Atrial FibrillationCathonABCNCT05635864
Impact of Catheter Ablation on ABC Risk Scores
An observational study of Atrial Fibrillation and Atrial Flutter, run by Hannover Medical School at 1 site in Germany.
Trial summary
The aim of this prospective, monocentric, non-randomized trial is to investigate the impact of catheter ablation of atrial tachyarrhythmias on the ABC-stroke and ABC-bleeding risk scores. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter, Stroke
- What is being tested?
- Catheter ablation
- Type of treatment
- Surgery or procedure
- How many people
- 167 participants
- Where
- 1 siteGermany
- Study dates
- 3 Jun 2021to 24 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients planned to undergo first catheter ablation for symptomatic atrial tachyarrhythmias (atrial fibrillation, atrial flutter) will be enrolled.
Who may be able to join
- Symptomatic atrial tachyarrhythmias (atrial fibrillation, atrial flutter)
- Planned for 1st right or left atrial ablation
- Informed consent
- at least 18 years
Who cannot join
- Previous left or right atrial ablation
- Ineligibility for catheter ablation
- History of TIA / stroke
- < 18 years
- LA thrombus formation or history of thrombus formation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Catheter Ablation of Atrial Tachyarrhythmias on ABC Stroke and ABC Bleeding Risk Scores
The aim of this prospective, monocentric, non-randomized trial is to investigate the impact of catheter ablation of atrial tachyarrhythmias on the ABC-stroke and ABC-bleeding risk scores.
Participants planned for first catheter ablation for symptomatic atrial tachyarrrhythmias (atrial fibrillation, atrial flutter) will be enrolled. Serial blood samples will be collected before and 3, 6 and 12 months after catheter ablation to calculate the ABC scores as well as the traditional bleeding and stroke risks. Following catheter ablation, continuous rhythm monitoring will be achieved using an insertable monitor or an implanted atrial lead of a cardiac implantable electronic device. Additionally, heart rate monitoring via photoplethysmography using a smartwatch and/or smartphone is performed for a period of six months.
Data are analyzed for differences in ABC scores before and after ablation in relation to possible AF/AT recurrences. Furthermore, we are going to compare the sensitivity and specificity of different follow-up modalities post ablation. The monitoring via ICM (gold standard) is compared to smartwatch-based monitoring alone, versus smartphone-based monitoring alone or a combination of both for AT/AF recurrences.
Read the detailed description
Atrial arrhythmias (e.g. atrial fibrillation, atrial flutter) are common arrhythmias in the general population and are associated with an increased risk for heart failure, stroke and systemic embolism. Guidelines recommend the start of oral anticoagulation for patients with atrial fibrillation and an increased risk for stroke, calculated using a common risk score, the CHA2DS2-VASc score, which is solely based on clinical variables (congestive heart failure, hypertension, diabetes mellitus, vascular disease, sex category, age and history of stroke). Clinical bleeding risk scores (e.g. HAS-BLED score) can be used to identify the bleeding risk for patients considered for the use of oral anticoagulation. Nevertheless, clinical based risk scores provide only moderate discrimination of risk for the individual patient. Recent studies have shown that biomarkers, such as NT-proBNP, hs-Troponin T, hemoglobin and GDF-15, are related to the risk of stroke and other outcomes of patients with atrial fibrillation. Combining the use of clinical parameters and the most important biomarkers named above, the ABC (age, biomarkers, clinical history)-stroke risk score and the ABC bleeding risk score were developed and internally as well as externally validated. Both, the ABC stroke risk score and the ABC bleeding risk score performed better than commonly used scores (CHA2DS2-VASc, HAS-BLED, ORBIT) and are suggested as useful tools for improved risk stratification and clinical decision making in patients with atrial fibrillation. For symptomatic atrial arrhythmias, catheter ablation is an accepted and recommended strategy for rhythm control. Registry data suggest a decrease in stroke rates following catheter ablation for atrial fibrillation. Prospective randomized trials are currently evaluating if oral anticoagulation can be stopped after successful catheter ablation. The impact of catheter ablation on the ABC scores as well as the usefulness of the ABC scores for clinical decision making after catheter ablation are unknown. We hypothesize that successful catheter ablation of atrial arrhythmia has an impact on biomarkers of the ABC scores and may alter ABC-predicted stroke and bleeding risk.
Serial blood samples during routine blood tests will be collected to calculate the ABC-stroke and bleeding scores after informed consent before and 3, 6 and 12 months after catheter ablation. Taken blood samples are going to be centrifugated and stored for possible further analysis. Clinical data will be collected to allow calculation of the CHADS2, CHA2DS2-VASc, HAS-BLED, ORBIT, HEMORR2HAGES and ATRIA scores. Additionally, patient characteristics, the clinical history, type of atrial tachycardia, concomitant medication, prescribed anticoagulation as well as the clinical history for atrial tachyarrhythmia recurrence, stroke, systemic embolism, bleeding 3, 6 and 12 months after catheter ablation are acquired. Patients undergo transthoracic echocardiogram on Day 0 as well as after 3, 6 and 12 months after catheter ablation analyzing echoparameters important for structural cardiac changes regarding atrial fibrillation following catheter ablation.
Following catheter ablation, an insertable cardiac monitor is going to be implanted (not necessary for patients with an implanted pacemaker with a functional atrial electrode) for monitoring of recurrences of atrial tachycardias during follow-up. Furthermore, additional heart rhythm monitoring via photoplethysmography (PPG) via the application "FibriCheck" (Fibricheck, Corda Campus, Kempische Steenweg 303/27, 3500 Hasselt, Belgium, www.fibricheck.com) is performed for a period of six months. Patients receive both a FibriCheck smartphone application and a Fitbit smartwatch with the semi-continuous monitoring solution. The smartwatch performs photoplethysmography-based recordings for one minute every nine minutes automatically. Patients are trained to manually record a photoplethysmography-based episode via the smartphone twice a day and in case of symptoms.
Furthermore, patient-reported outcomes are going to be evaluated at inclusion as well as at every follow-up asking the patients to fill in three validated questionnaires on quality of life: EQ-5D-5L, AFEQT and HADS.
Data are analyzed for differences in ABC scores before and after ablation in relation to possible AF-/AT recurrences. Furthermore, we are going to compare the sensitivity and specificity of different follow-up modalities post ablation. The monitoring via ICM (gold standard) is compared to smartwatch-based monitoring alone, versus smartphone-based monitoring alone or a combination of both for AT/AF recurrences.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Stroke, Bleeding, Atrial Remodeling, Recurrences
- Being tested
- Catheter ablation
- Keywords
- Atrial Fibrillation, Atrial Flutter, ABC score, Wearables, Stroke risk, Bleeding risk, Photoplethysmography, Implantable loop recorder
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter, Stroke, Hemorrhage, Atrial Remodeling, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationProcedure or surgery
Catheter ablation of atrial tachyarrhythmia (atrial fibrillation, atrial flutter)
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of catheter ablation of atrial tachycardias on the ABC stroke-score assessing the change 3,6 and 12 months after catheter ablation
Impact of catheter ablation of atrial tachycardias (atrial fibrillation, atrial flutter) on the ABC stroke-score assessing the change 3 months after catheter ablation
Measured: 3 months after catheter ablation
Impact of catheter ablation of atrial tachycardias on the ABC stroke-score assessing the change 3,6 and 12 months after catheter ablation
Impact of catheter ablation of atrial tachycardias (atrial fibrillation, atrial flutter) on the ABC stroke-score assessing the change 6 months after catheter ablation
Measured: 6 months after catheter ablation
Impact of catheter ablation of atrial tachycardias on the ABC stroke-score assessing the change 3,6 and 12 months after catheter ablation
Impact of catheter ablation of atrial tachycardias (atrial fibrillation, atrial flutter) on the ABC stroke-score assessing the change 12 months after catheter ablation
Measured: 12 months after catheter ablation
Impact of catheter ablation of atrial tachycardias on the ABC bleeding-score assessing the change 3,6 and 12 months after catheter ablation
Impact of catheter ablation of atrial tachycardias (atrial fibrillation, atrial flutter) on the ABC bleeding-score assessing the change 3 months after catheter ablation
Measured: 3 months after catheter ablation
Impact of catheter ablation of atrial tachycardias on the ABC bleeding-score assessing the change 3,6 and 12 months after catheter ablation
Impact of catheter ablation of atrial tachycardias (atrial fibrillation, atrial flutter) on the ABC bleeding-score assessing the change 6 months after catheter ablation
Measured: 6 months after catheter ablation
Impact of catheter ablation of atrial tachycardias on the ABC bleeding-score assessing the change 3,6 and 12 months after catheter ablation
Impact of catheter ablation of atrial tachycardias (atrial fibrillation, atrial flutter) on the ABC bleeding-score assessing the change 12 months after catheter ablation
Measured: 12 months after catheter ablation
Secondary outcomes (4)
Number of clinical events post catheter ablation in relation to ABC score-predicted risks
Number of clinical events (e.g. stroke, systemic embolism, bleeding) in regard to ABC score-predicte risks
Measured: 3,6 and 12 months after catheter ablation
Number of clinical events post catheter ablation in relation to traditional score-predicted risks
Number of clinical events (e.g. stroke, systemic embolism, bleeding) in regard to traditional score-predicted risks e.g. CHADS2, CHA2DS2-VASc, HAS-BLED, ORBIT, ATRIA, HEMORR2HAGES
Measured: 3,6 and 12 months after catheter ablation
Impact of the recurrence rate after catheter ablation on the ABC stroke- and bleeding risk scores
The impact of recurrence rate of atrial tachycardia after catheter ablation on the ABC-stroke and ABC-bleeding risk scores
Measured: 3,6 and 12 months after catheter ablation
Comparison of insertable cardiac monitor vs. smartwatch vs. smartphone-based follow-up with respect to atrial tachycardias (AT) / atrial fibrillation (AF) recurrences post catheter ablation
Comparison of detection of recurrences in regard to different tools, taking the implantable loop recorder as the gold standard and comparing it to semicontinuous and active photoplethysmography-based wearable tools
Measured: Wearables: within the first 6 months after catheter ablation, implantable loop recorder: 3,6 and 12 months after catheter ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start3 Jun 2021
- Primary completion24 Nov 2025
- Study completion24 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Sponsor
- Investigators
- David Duncker, Prof. Dr., Principal investigator, Hannover Medical School, Carl-Neuberg Str. 1, 30625 Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635864
- Sponsor's protocol ID
- 9112_BO_S_2020
- Acronym
- CathonABC
- Status last verified
- Sep 2025
- First submitted
- 4 Nov 2022
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brugada J, Katritsis DG, Arbelo E, Arribas F, Bax JJ, Blomstrom-Lundqvist C, Calkins H, Corrado D, Deftereos SG, Diller GP, Gomez-Doblas JJ, Gorenek B, Grace A, Ho SY, Kaski JC, Kuck KH, Lambiase PD, Sacher F, Sarquella-Brugada G, Suwalski P, Zaza A; ESC Scientific Document Group. 2019 ESC Guidelines for the management of patients with supraventricular tachycardiaThe Task Force for the management of patients with supraventricular tachycardia of the European Society of Cardiology (ESC). Eur Heart J. 2020 Feb 1;41(5):655-720. doi: 10.1093/eurheartj/ehz467. No abstract available.
PubMed 31504425Lip GY, Lane DA. Stroke prevention in atrial fibrillation: a systematic review. JAMA. 2015 May 19;313(19):1950-62. doi: 10.1001/jama.2015.4369.
PubMed 25988464Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines-CPG; Document Reviewers. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation--developed with the special contribution of the European Heart Rhythm Association. Europace. 2012 Oct;14(10):1385-413. doi: 10.1093/europace/eus305. Epub 2012 Aug 24. No abstract available.
PubMed 22923145Hijazi Z, Oldgren J, Siegbahn A, Granger CB, Wallentin L. Biomarkers in atrial fibrillation: a clinical review. Eur Heart J. 2013 May;34(20):1475-80. doi: 10.1093/eurheartj/eht024. Epub 2013 Feb 5.
PubMed 23386711Hijazi Z, Oldgren J, Andersson U, Connolly SJ, Ezekowitz MD, Hohnloser SH, Reilly PA, Vinereanu D, Siegbahn A, Yusuf S, Wallentin L. Cardiac biomarkers are associated with an increased risk of stroke and death in patients with atrial fibrillation: a Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) substudy. Circulation. 2012 Apr 3;125(13):1605-16. doi: 10.1161/CIRCULATIONAHA.111.038729. Epub 2012 Feb 28.
PubMed 22374183Hijazi Z, Lindback J, Alexander JH, Hanna M, Held C, Hylek EM, Lopes RD, Oldgren J, Siegbahn A, Stewart RA, White HD, Granger CB, Wallentin L; ARISTOTLE and STABILITY Investigators. The ABC (age, biomarkers, clinical history) stroke risk score: a biomarker-based risk score for predicting stroke in atrial fibrillation. Eur Heart J. 2016 May 21;37(20):1582-90. doi: 10.1093/eurheartj/ehw054. Epub 2016 Feb 25.
PubMed 26920728Hijazi Z, Oldgren J, Lindback J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Held C, Hylek EM, Lopes RD, Siegbahn A, Yusuf S, Granger CB, Wallentin L; ARISTOTLE and RE-LY Investigators. The novel biomarker-based ABC (age, biomarkers, clinical history)-bleeding risk score for patients with atrial fibrillation: a derivation and validation study. Lancet. 2016 Jun 4;387(10035):2302-2311. doi: 10.1016/S0140-6736(16)00741-8. Epub 2016 Apr 4.
PubMed 27056738Berg DD, Ruff CT, Jarolim P, Giugliano RP, Nordio F, Lanz HJ, Mercuri MF, Antman EM, Braunwald E, Morrow DA. Performance of the ABC Scores for Assessing the Risk of Stroke or Systemic Embolism and Bleeding in Patients With Atrial Fibrillation in ENGAGE AF-TIMI 48. Circulation. 2019 Feb 5;139(6):760-771. doi: 10.1161/CIRCULATIONAHA.118.038312.
PubMed 30586727Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.
PubMed 27567408Bunch TJ, May HT, Bair TL, Weiss JP, Crandall BG, Osborn JS, Mallender C, Anderson JL, Muhlestein BJ, Lappe DL, Day JD. Atrial fibrillation ablation patients have long-term stroke rates similar to patients without atrial fibrillation regardless of CHADS2 score. Heart Rhythm. 2013 Sep;10(9):1272-7. doi: 10.1016/j.hrthm.2013.07.002. Epub 2013 Jul 5.
PubMed 23835257Hunter RJ, McCready J, Diab I, Page SP, Finlay M, Richmond L, French A, Earley MJ, Sporton S, Jones M, Joseph JP, Bashir Y, Betts TR, Thomas G, Staniforth A, Lee G, Kistler P, Rajappan K, Chow A, Schilling RJ. Maintenance of sinus rhythm with an ablation strategy in patients with atrial fibrillation is associated with a lower risk of stroke and death. Heart. 2012 Jan;98(1):48-53. doi: 10.1136/heartjnl-2011-300720. Epub 2011 Sep 19.
PubMed 21930724Themistoclakis S, Corrado A, Marchlinski FE, Jais P, Zado E, Rossillo A, Di Biase L, Schweikert RA, Saliba WI, Horton R, Mohanty P, Patel D, Burkhardt DJ, Wazni OM, Bonso A, Callans DJ, Haissaguerre M, Raviele A, Natale A. The risk of thromboembolism and need for oral anticoagulation after successful atrial fibrillation ablation. J Am Coll Cardiol. 2010 Feb 23;55(8):735-43. doi: 10.1016/j.jacc.2009.11.039.
PubMed 20170810Verma A, Ha ACT, Kirchhof P, Hindricks G, Healey JS, Hill MD, Sharma M, Wyse DG, Champagne J, Essebag V, Wells G, Gupta D, Heidbuchel H, Sanders P, Birnie DH. The Optimal Anti-Coagulation for Enhanced-Risk Patients Post-Catheter Ablation for Atrial Fibrillation (OCEAN) trial. Am Heart J. 2018 Mar;197:124-132. doi: 10.1016/j.ahj.2017.12.007. Epub 2017 Dec 8.
PubMed 29447772Schrickel JW, Linhart M, Bansch D, Thomas D, Nickenig G. Rationale and design of the ODIn-AF Trial: randomized evaluation of the prevention of silent cerebral thromboembolism by oral anticoagulation with dabigatran after pulmonary vein isolation for atrial fibrillation. Clin Res Cardiol. 2016 Feb;105(2):95-105. doi: 10.1007/s00392-015-0933-1. Epub 2015 Oct 29.
PubMed 26514352
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Catheter Ablation of Atrial Tachyarrhythmias on ABC Stroke and ABC Bleeding Risk Scores
- ClinicalTrials.gov ID
- NCT05635864
- Acronym / sponsor ID
- CathonABC / 9112_BO_S_2020
- Conditions
- Atrial Fibrillation, Atrial Flutter, Stroke, Bleeding, Atrial Remodeling, Recurrences
- Keywords
- Atrial Fibrillation, Atrial Flutter, ABC score, Wearables, Stroke risk, Bleeding risk, Photoplethysmography, Implantable loop recorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 24 Nov 2025 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this prospective, monocentric, non-randomized trial is to investigate the impact of catheter ablation of atrial tachyarrhythmias on the ABC-stroke and ABC-bleeding risk scores.
Participants planned for first catheter ablation for symptomatic atrial tachyarrrhythmias (atrial fibrillation, atrial flutter) will be enrolled. Serial blood samples will be collected before and 3, 6 and 12 months after catheter ablation to calculate the ABC scores as well as the traditional bleeding and stroke risks. Following catheter ablation, continuous rhythm monitoring will be achieved using an insertable monitor or an implanted atrial lead of a cardiac implantable electronic device. Additionally, heart rate monitoring via photoplethysmography using a smartwatch and/or smartphone is performed for a period of six months.
Data are analyzed for differences in ABC scores before and after ablation in relation to possible AF/AT recurrences. Furthermore, we are going to compare the sensitivity and specificity of different follow-up modalities post ablation. The monitoring via ICM (gold standard) is compared to smartwatch-based monitoring alone, versus smartphone-based monitoring alone or a combination of both for AT/AF recurrences.
Detailed description
Atrial arrhythmias (e.g. atrial fibrillation, atrial flutter) are common arrhythmias in the general population and are associated with an increased risk for heart failure, stroke and systemic embolism. Guidelines recommend the start of oral anticoagulation for patients with atrial fibrillation and an increased risk for stroke, calculated using a common risk score, the CHA2DS2-VASc score, which is solely based on clinical variables (congestive heart failure, hypertension, diabetes mellitus, vascular disease, sex category, age and history of stroke). Clinical bleeding risk scores (e.g. HAS-BLED score) can be used to identify the bleeding risk for patients considered for the use of oral anticoagulation. Nevertheless, clinical based risk scores provide only moderate discrimination of risk for the individual patient. Recent studies have shown that biomarkers, such as NT-proBNP, hs-Troponin T, hemoglobin and GDF-15, are related to the risk of stroke and other outcomes of patients with atrial fibrillation. Combining the use of clinical parameters and the most important biomarkers named above, the ABC (age, biomarkers, clinical history)-stroke risk score and the ABC bleeding risk score were developed and internally as well as externally validated. Both, the ABC stroke risk score and the ABC bleeding risk score performed better than commonly used scores (CHA2DS2-VASc, HAS-BLED, ORBIT) and are suggested as useful tools for improved risk stratification and clinical decision making in patients with atrial fibrillation. For symptomatic atrial arrhythmias, catheter ablation is an accepted and recommended strategy for rhythm control. Registry data suggest a decrease in stroke rates following catheter ablation for atrial fibrillation. Prospective randomized trials are currently evaluating if oral anticoagulation can be stopped after successful catheter ablation. The impact of catheter ablation on the ABC scores as well as the usefulness of the ABC scores for clinical decision making after catheter ablation are unknown. We hypothesize that successful catheter ablation of atrial arrhythmia has an impact on biomarkers of the ABC scores and may alter ABC-predicted stroke and bleeding risk.
Serial blood samples during routine blood tests will be collected to calculate the ABC-stroke and bleeding scores after informed consent before and 3, 6 and 12 months after catheter ablation. Taken blood samples are going to be centrifugated and stored for possible further analysis. Clinical data will be collected to allow calculation of the CHADS2, CHA2DS2-VASc, HAS-BLED, ORBIT, HEMORR2HAGES and ATRIA scores. Additionally, patient characteristics, the clinical history, type of atrial tachycardia, concomitant medication, prescribed anticoagulation as well as the clinical history for atrial tachyarrhythmia recurrence, stroke, systemic embolism, bleeding 3, 6 and 12 months after catheter ablation are acquired. Patients undergo transthoracic echocardiogram on Day 0 as well as after 3, 6 and 12 months after catheter ablation analyzing echoparameters important for structural cardiac changes regarding atrial fibrillation following catheter ablation.
Following catheter ablation, an insertable cardiac monitor is going to be implanted (not necessary for patients with an implanted pacemaker with a functional atrial electrode) for monitoring of recurrences of atrial tachycardias during follow-up. Furthermore, additional heart rhythm monitoring via photoplethysmography (PPG) via the application "FibriCheck" (Fibricheck, Corda Campus, Kempische Steenweg 303/27, 3500 Hasselt, Belgium, www.fibricheck.com) is performed for a period of six months. Patients receive both a FibriCheck smartphone application and a Fitbit smartwatch with the semi-continuous monitoring solution. The smartwatch performs photoplethysmography-based recordings for one minute every nine minutes automatically. Patients are trained to manually record a photoplethysmography-based episode via the smartphone twice a day and in case of symptoms.
Furthermore, patient-reported outcomes are going to be evaluated at inclusion as well as at every follow-up asking the patients to fill in three validated questionnaires on quality of life: EQ-5D-5L, AFEQT and HADS.
Data are analyzed for differences in ABC scores before and after ablation in relation to possible AF-/AT recurrences. Furthermore, we are going to compare the sensitivity and specificity of different follow-up modalities post ablation. The monitoring via ICM (gold standard) is compared to smartwatch-based monitoring alone, versus smartphone-based monitoring alone or a combination of both for AT/AF recurrences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients planned to undergo first catheter ablation for symptomatic atrial tachyarrhythmias (atrial fibrillation, atrial flutter) will be enrolled.
Key inclusion criteria (4 listed)
- Symptomatic atrial tachyarrhythmias (atrial fibrillation, atrial flutter)
- Planned for 1st right or left atrial ablation
- Informed consent
- at least 18 years
Key exclusion criteria (5 listed)
- Previous left or right atrial ablation
- Ineligibility for catheter ablation
- History of TIA / stroke
- < 18 years
- LA thrombus formation or history of thrombus formation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter ablationCatheter ablation of atrial tachyarrhythmia (atrial fibrillation, atrial flutter) | Procedure or surgery | – |
Primary outcome
Impact of catheter ablation of atrial tachycardias on the ABC stroke-score assessing the change 3,6 and 12 months after catheter ablation
Time frame: 3 months after catheter ablation
Impact of catheter ablation of atrial tachycardias (atrial fibrillation, atrial flutter) on the ABC stroke-score assessing the change 3 months after catheter ablation
Impact of catheter ablation of atrial tachycardias on the ABC stroke-score assessing the change 3,6 and 12 months after catheter ablation
Time frame: 6 months after catheter ablation
Impact of catheter ablation of atrial tachycardias (atrial fibrillation, atrial flutter) on the ABC stroke-score assessing the change 6 months after catheter ablation
Impact of catheter ablation of atrial tachycardias on the ABC stroke-score assessing the change 3,6 and 12 months after catheter ablation
Time frame: 12 months after catheter ablation
Impact of catheter ablation of atrial tachycardias (atrial fibrillation, atrial flutter) on the ABC stroke-score assessing the change 12 months after catheter ablation
Impact of catheter ablation of atrial tachycardias on the ABC bleeding-score assessing the change 3,6 and 12 months after catheter ablation
Time frame: 3 months after catheter ablation
Impact of catheter ablation of atrial tachycardias (atrial fibrillation, atrial flutter) on the ABC bleeding-score assessing the change 3 months after catheter ablation
Impact of catheter ablation of atrial tachycardias on the ABC bleeding-score assessing the change 3,6 and 12 months after catheter ablation
Time frame: 6 months after catheter ablation
Impact of catheter ablation of atrial tachycardias (atrial fibrillation, atrial flutter) on the ABC bleeding-score assessing the change 6 months after catheter ablation
Impact of catheter ablation of atrial tachycardias on the ABC bleeding-score assessing the change 3,6 and 12 months after catheter ablation
Time frame: 12 months after catheter ablation
Impact of catheter ablation of atrial tachycardias (atrial fibrillation, atrial flutter) on the ABC bleeding-score assessing the change 12 months after catheter ablation
4 secondary outcomes
Number of clinical events post catheter ablation in relation to ABC score-predicted risks
Time frame: 3,6 and 12 months after catheter ablation
Number of clinical events post catheter ablation in relation to traditional score-predicted risks
Time frame: 3,6 and 12 months after catheter ablation
Impact of the recurrence rate after catheter ablation on the ABC stroke- and bleeding risk scores
Time frame: 3,6 and 12 months after catheter ablation
Comparison of insertable cardiac monitor vs. smartwatch vs. smartphone-based follow-up with respect to atrial tachycardias (AT) / atrial fibrillation (AF) recurrences post catheter ablation
Time frame: Wearables: within the first 6 months after catheter ablation, implantable loop recorder: 3,6 and 12 months after catheter ablation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Background: PubMed 31504425Brugada J, Katritsis DG, Arbelo E, Arribas F, Bax JJ, Blomstrom-Lundqvist C, Calkins H, Corrado D, Deftereos SG, Diller GP, Gomez-Doblas JJ, Gorenek B, Grace A, Ho SY, Kaski JC, Kuck KH, Lambiase PD, Sacher F, Sarquella-Brugada G, Suwalski P, Zaza A; ESC Scientific Document Group. 2019 ESC Guidelines for the management of patients with supraventricular tachycardiaThe Task Force for the management of patients with supraventricular tachycardia of the European Society of Cardiology (ESC). Eur Heart J. 2020 Feb 1;41(5):655-720. doi: 10.1093/eurheartj/ehz467. No abstract available.
- Background: PubMed 25988464Lip GY, Lane DA. Stroke prevention in atrial fibrillation: a systematic review. JAMA. 2015 May 19;313(19):1950-62. doi: 10.1001/jama.2015.4369.
- Background: PubMed 22923145Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines-CPG; Document Reviewers. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation--developed with the special contribution of the European Heart Rhythm Association. Europace. 2012 Oct;14(10):1385-413. doi: 10.1093/europace/eus305. Epub 2012 Aug 24. No abstract available.
- Background: PubMed 23386711Hijazi Z, Oldgren J, Siegbahn A, Granger CB, Wallentin L. Biomarkers in atrial fibrillation: a clinical review. Eur Heart J. 2013 May;34(20):1475-80. doi: 10.1093/eurheartj/eht024. Epub 2013 Feb 5.
- Background: PubMed 22374183Hijazi Z, Oldgren J, Andersson U, Connolly SJ, Ezekowitz MD, Hohnloser SH, Reilly PA, Vinereanu D, Siegbahn A, Yusuf S, Wallentin L. Cardiac biomarkers are associated with an increased risk of stroke and death in patients with atrial fibrillation: a Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) substudy. Circulation. 2012 Apr 3;125(13):1605-16. doi: 10.1161/CIRCULATIONAHA.111.038729. Epub 2012 Feb 28.
- Background: PubMed 26920728Hijazi Z, Lindback J, Alexander JH, Hanna M, Held C, Hylek EM, Lopes RD, Oldgren J, Siegbahn A, Stewart RA, White HD, Granger CB, Wallentin L; ARISTOTLE and STABILITY Investigators. The ABC (age, biomarkers, clinical history) stroke risk score: a biomarker-based risk score for predicting stroke in atrial fibrillation. Eur Heart J. 2016 May 21;37(20):1582-90. doi: 10.1093/eurheartj/ehw054. Epub 2016 Feb 25.
- Background: PubMed 27056738Hijazi Z, Oldgren J, Lindback J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Held C, Hylek EM, Lopes RD, Siegbahn A, Yusuf S, Granger CB, Wallentin L; ARISTOTLE and RE-LY Investigators. The novel biomarker-based ABC (age, biomarkers, clinical history)-bleeding risk score for patients with atrial fibrillation: a derivation and validation study. Lancet. 2016 Jun 4;387(10035):2302-2311. doi: 10.1016/S0140-6736(16)00741-8. Epub 2016 Apr 4.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Duncker, Prof. Dr. principal investigator
Hannover Medical School, Carl-Neuberg Str. 1, 30625 Hannover
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Flutter, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of catheter ablation of atrial tachycardias on the ABC stroke-score assessing the change 3,6 and 12 months after catheter ablation (time frame: 3 months after catheter ablation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05635864, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.