TAVINCT04298593
Assessment of Arrhythmic BuRdEn With Post-ProCedural COntinuous ElectRocarDiographic Monitoring in Patients Undergoing Transcatheter Aortic Valve Implantation: The RECORD Study
A study testing Cardiostat in people with TAVI and ECG Monitoring, run by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval at 1 site in Canada.
Trial summary
TAVI recipients exhibit a high burden of arrhythmic events early after the procedure. ECG continuous monitoring could be useful to diagnose and facilitate early implementation of specific therapeutic measures in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TAVI, ECG Monitoring
- What is being tested?
- Cardiostat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jun 2019to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients with severe aortic stenosis undergoing TAVI with either balloon or self-expandable valves.
Who cannot join
- Failure to provide informed consent.
- Prior or post-procedural pacemaker
- In-hospital death
- Logistic reasons precluding ECG monitoring within the 4 weeks after the procedure
- Participation in another continuous ECG monitoring post-TAVI trial
Trial locations and contacts
1 site in 1 country.
About this study
TAVI recipients exhibit a high burden of arrhythmic events early after the procedure. ECG continuous monitoring could be useful to diagnose and facilitate early implementation of specific therapeutic measures in these patients.
Read the detailed description
Prospective registry including patients accepted by the heart team for a TAVI procedure. Patients will undergo a prolonged continuous ECG monitoring using the CardioSTAT® device after hospital discharge. Following the TAVI procedure, continuous ECG monitoring will start just before hospital discharge and prolonged up to 4 weeks. There won't be any restriction regarding the type of valve and approach used for the TAVI procedure.
All type of arrhythmic events will be recorded, as well as the specific therapeutic measures implemented upon the diagnosis of the arrhythmic event.
Analyses of the CardioSTAT will be done at 2 and 4 weeks following hospital discharge. Clinical follow-up will be performed at 14 days (analysis of CardioSTAT® record), 28 days (analysis of CardioSTAT record), 1 year post-TAVI and yearly thereafter up to 5-year follow-up.
- Conditions
- TAVI, ECG Monitoring
- Being tested
- Cardiostat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardiostatDevice
This is a prospective observational study including patients accepted by the heart team for a TAVI procedure. There will be no restriction regarding the type of valve and approach used for the TAVI procedure. Following the TAVI procedure, the patients will be under telemetry until hospital discharge and, at hospital discharge, they will be monitorized up to 4 more weeks using the CardioSTAT® device.
| Study group | Role | What they receive |
|---|---|---|
| ECG monitoring | Other | All patient will be under telemetry Receives: Device: Cardiostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of arrhythmic events
Incidence of arrhythmic events after discharge in TAVI recipients.
Measured: within the first weeks after the procedure, an average of 4 weeks
Type of arrhythmic events
Type of arrhythmic events after discharge in TAVI recipients.
Measured: within the first weeks after the procedure, an average of 4 weeks
Incidence of arrhythmic events and treatment modification
Incidence of arrhythmic events leading to a specific change in treatment.
Measured: within the first weeks after the procedure, an average of 4 weeks
Type of arrhythmic events and treatment modification
Type of arrhythmic events leading to a specific change in treatment.
Measured: within the first weeks after the procedure, an average of 4 weeks
Secondary outcomes (2)
Number of participants with pacemaker
Incidence of permanent pacemaker implantation after the procedure.
Measured: Through study completion, an average of 5 years
Number of participants with treatment modification
Number of participants who required change in their medication (anticoagulation, antiarrhythmic) after the procedure.
Measured: Through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start28 Jun 2019
- Primary completion31 Dec 2021
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for TAVIStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective registry
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep Rodes-Cabau, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298593
- Sponsor's protocol ID
- RECORD
- Status last verified
- Mar 2026
- First submitted
- 12 Jan 2020
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Munoz DR, Rosenhek R, Sjogren J, Mas PT, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL. 2017 ESC/EACTS Guidelines for the Management of Valvular Heart Disease. Rev Esp Cardiol (Engl Ed). 2018 Feb;71(2):110. doi: 10.1016/j.rec.2017.12.013. No abstract available. English, Spanish.
PubMed 29425605Auffret V, Puri R, Urena M, Chamandi C, Rodriguez-Gabella T, Philippon F, Rodes-Cabau J. Conduction Disturbances After Transcatheter Aortic Valve Replacement: Current Status and Future Perspectives. Circulation. 2017 Sep 12;136(11):1049-1069. doi: 10.1161/CIRCULATIONAHA.117.028352.
PubMed 28893961Urena M, Rodes-Cabau J. Conduction Abnormalities: The True Achilles' Heel of Transcatheter Aortic Valve Replacement? JACC Cardiovasc Interv. 2016 Nov 14;9(21):2217-2219. doi: 10.1016/j.jcin.2016.09.040. No abstract available.
PubMed 27832847Moreno R, Dobarro D, Lopez de Sa E, Prieto M, Morales C, Calvo Orbe L, Moreno-Gomez I, Filgueiras D, Sanchez-Recalde A, Galeote G, Jimenez-Valero S, Lopez-Sendon JL. Cause of complete atrioventricular block after percutaneous aortic valve implantation: insights from a necropsy study. Circulation. 2009 Aug 4;120(5):e29-30. doi: 10.1161/CIRCULATIONAHA.109.849281. No abstract available.
PubMed 19652115Siontis GCM, Praz F, Lanz J, Vollenbroich R, Roten L, Stortecky S, Raber L, Windecker S, Pilgrim T. New-onset arrhythmias following transcatheter aortic valve implantation: a systematic review and meta-analysis. Heart. 2018 Jul;104(14):1208-1215. doi: 10.1136/heartjnl-2017-312310. Epub 2017 Dec 23.
PubMed 29275399Rodes-Cabau J, Urena M, Nombela-Franco L, Amat-Santos I, Kleiman N, Munoz-Garcia A, Atienza F, Serra V, Deyell MW, Veiga-Fernandez G, Masson JB, Canadas-Godoy V, Himbert D, Castrodeza J, Elizaga J, Francisco Pascual J, Webb JG, de la Torre JM, Asmarats L, Pelletier-Beaumont E, Philippon F. Arrhythmic Burden as Determined by Ambulatory Continuous Cardiac Monitoring in Patients With New-Onset Persistent Left Bundle Branch Block Following Transcatheter Aortic Valve Replacement: The MARE Study. JACC Cardiovasc Interv. 2018 Aug 13;11(15):1495-1505. doi: 10.1016/j.jcin.2018.04.016. Epub 2018 Jul 18.
PubMed 30031719Mautner RK, Phillips JH. Atrioventricular and intraventricular conduction disturbances in aortic valvular disease. South Med J. 1980 May;73(5):572-8, 581. doi: 10.1097/00007611-198005000-00008.
PubMed 7375971Widgren V, Dencker M, Juhlin T, Platonov P, Willenheimer R. Aortic stenosis and mitral regurgitation as predictors of atrial fibrillation during 11 years of follow-up. BMC Cardiovasc Disord. 2012 Oct 18;12:92. doi: 10.1186/1471-2261-12-92.
PubMed 23075140MacMillan RM, Demorizi NM, Gessman LJ, Maranhao V. Correlates of prolonged HV conduction in aortic stenosis. Am Heart J. 1985 Jul;110(1 Pt 1):56-60. doi: 10.1016/0002-8703(85)90514-9.
PubMed 4013990Fischer Q, Nault I, Cepas-Guillen P, Avvedimento M, Benavent-Garcia C, Pelletier-Beaumont E, Philippon F, Rodes-Cabau J. Systematic Ambulatory ECG Monitoring for Preventing Life-Threatening Cardiovascular Events Following TAVR. Circ Cardiovasc Interv. 2026 Apr 30:e016288. doi: 10.1161/CIRCINTERVENTIONS.125.016288. Online ahead of print.
PubMed 42059075
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Arrhythmic BuRdEn With Post-ProCedural COntinuous ElectRocarDiographic Monitoring in Patients Undergoing Transcatheter Aortic Valve Implantation: The RECORD Study
- ClinicalTrials.gov ID
- NCT04298593
- Acronym / sponsor ID
- RECORD
- Conditions
- TAVI, ECG Monitoring
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University LavalUniversity, hospital or other
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Mar 2020 (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.
TAVI recipients exhibit a high burden of arrhythmic events early after the procedure. ECG continuous monitoring could be useful to diagnose and facilitate early implementation of specific therapeutic measures in these patients.
Detailed description
Prospective registry including patients accepted by the heart team for a TAVI procedure. Patients will undergo a prolonged continuous ECG monitoring using the CardioSTAT® device after hospital discharge. Following the TAVI procedure, continuous ECG monitoring will start just before hospital discharge and prolonged up to 4 weeks. There won't be any restriction regarding the type of valve and approach used for the TAVI procedure.
All type of arrhythmic events will be recorded, as well as the specific therapeutic measures implemented upon the diagnosis of the arrhythmic event.
Analyses of the CardioSTAT will be done at 2 and 4 weeks following hospital discharge. Clinical follow-up will be performed at 14 days (analysis of CardioSTAT® record), 28 days (analysis of CardioSTAT record), 1 year post-TAVI and yearly thereafter up to 5-year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective registry
| Arm | Type | Receives |
|---|---|---|
| ECG monitoring | Other | Device: CardiostatAll patient will be under telemetry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with severe aortic stenosis undergoing TAVI with either balloon or self-expandable valves.
Key exclusion criteria (5 listed)
- Failure to provide informed consent.
- Prior or post-procedural pacemaker
- In-hospital death
- Logistic reasons precluding ECG monitoring within the 4 weeks after the procedure
- Participation in another continuous ECG monitoring post-TAVI trial
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 |
|---|---|---|
| CardiostatThis is a prospective observational study including patients accepted by the heart team for a TAVI procedure. There will be no restriction regarding the type of valve and approach used for the TAVI procedure. Following the TAVI procedure, the patients will be under telemetry until hospital discharge and, at hospital discharge, they will be monitorized up to 4 more weeks using the CardioSTAT® device. | Device | ECG monitoring |
Primary outcome
Incidence of arrhythmic events
Time frame: within the first weeks after the procedure, an average of 4 weeks
Incidence of arrhythmic events after discharge in TAVI recipients.
Type of arrhythmic events
Time frame: within the first weeks after the procedure, an average of 4 weeks
Type of arrhythmic events after discharge in TAVI recipients.
Incidence of arrhythmic events and treatment modification
Time frame: within the first weeks after the procedure, an average of 4 weeks
Incidence of arrhythmic events leading to a specific change in treatment.
Type of arrhythmic events and treatment modification
Time frame: within the first weeks after the procedure, an average of 4 weeks
Type of arrhythmic events leading to a specific change in treatment.
2 secondary outcomes
Number of participants with pacemaker
Time frame: Through study completion, an average of 5 years
Number of participants with treatment modification
Time frame: Through study completion, an average of 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 29425605Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Munoz DR, Rosenhek R, Sjogren J, Mas PT, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL. 2017 ESC/EACTS Guidelines for the Management of Valvular Heart Disease. Rev Esp Cardiol (Engl Ed). 2018 Feb;71(2):110. doi: 10.1016/j.rec.2017.12.013. No abstract available. English, Spanish.
- Background: PubMed 28893961Auffret V, Puri R, Urena M, Chamandi C, Rodriguez-Gabella T, Philippon F, Rodes-Cabau J. Conduction Disturbances After Transcatheter Aortic Valve Replacement: Current Status and Future Perspectives. Circulation. 2017 Sep 12;136(11):1049-1069. doi: 10.1161/CIRCULATIONAHA.117.028352.
- Background: PubMed 27832847Urena M, Rodes-Cabau J. Conduction Abnormalities: The True Achilles' Heel of Transcatheter Aortic Valve Replacement? JACC Cardiovasc Interv. 2016 Nov 14;9(21):2217-2219. doi: 10.1016/j.jcin.2016.09.040. No abstract available.
- Background: PubMed 19652115Moreno R, Dobarro D, Lopez de Sa E, Prieto M, Morales C, Calvo Orbe L, Moreno-Gomez I, Filgueiras D, Sanchez-Recalde A, Galeote G, Jimenez-Valero S, Lopez-Sendon JL. Cause of complete atrioventricular block after percutaneous aortic valve implantation: insights from a necropsy study. Circulation. 2009 Aug 4;120(5):e29-30. doi: 10.1161/CIRCULATIONAHA.109.849281. No abstract available.
- Background: PubMed 29275399Siontis GCM, Praz F, Lanz J, Vollenbroich R, Roten L, Stortecky S, Raber L, Windecker S, Pilgrim T. New-onset arrhythmias following transcatheter aortic valve implantation: a systematic review and meta-analysis. Heart. 2018 Jul;104(14):1208-1215. doi: 10.1136/heartjnl-2017-312310. Epub 2017 Dec 23.
- Background: PubMed 30031719Rodes-Cabau J, Urena M, Nombela-Franco L, Amat-Santos I, Kleiman N, Munoz-Garcia A, Atienza F, Serra V, Deyell MW, Veiga-Fernandez G, Masson JB, Canadas-Godoy V, Himbert D, Castrodeza J, Elizaga J, Francisco Pascual J, Webb JG, de la Torre JM, Asmarats L, Pelletier-Beaumont E, Philippon F. Arrhythmic Burden as Determined by Ambulatory Continuous Cardiac Monitoring in Patients With New-Onset Persistent Left Bundle Branch Block Following Transcatheter Aortic Valve Replacement: The MARE Study. JACC Cardiovasc Interv. 2018 Aug 13;11(15):1495-1505. doi: 10.1016/j.jcin.2018.04.016. Epub 2018 Jul 18.
- Background: PubMed 7375971Mautner RK, Phillips JH. Atrioventricular and intraventricular conduction disturbances in aortic valvular disease. South Med J. 1980 May;73(5):572-8, 581. doi: 10.1097/00007611-198005000-00008.
- Background: PubMed 23075140Widgren V, Dencker M, Juhlin T, Platonov P, Willenheimer R. Aortic stenosis and mitral regurgitation as predictors of atrial fibrillation during 11 years of follow-up. BMC Cardiovasc Disord. 2012 Oct 18;12:92. doi: 10.1186/1471-2261-12-92.
- Background: PubMed 4013990MacMillan RM, Demorizi NM, Gessman LJ, Maranhao V. Correlates of prolonged HV conduction in aortic stenosis. Am Heart J. 1985 Jul;110(1 Pt 1):56-60. doi: 10.1016/0002-8703(85)90514-9.
- Derived from this study: PubMed 42059075Fischer Q, Nault I, Cepas-Guillen P, Avvedimento M, Benavent-Garcia C, Pelletier-Beaumont E, Philippon F, Rodes-Cabau J. Systematic Ambulatory ECG Monitoring for Preventing Life-Threatening Cardiovascular Events Following TAVR. Circ Cardiovasc Interv. 2026 Apr 30:e016288. doi: 10.1161/CIRCINTERVENTIONS.125.016288. Online ahead of print.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiostat in people with TAVI and ECG Monitoring, run by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval at 1 site in Canada.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 27 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of arrhythmic events (time frame: within the first weeks after the procedure, an average of 4 weeks). The study lists 4 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 NCT04298593, which also lists 10 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 27 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.