Atrial Fibrillation - SymptomaticNCT03355456
Low Voltage-Directed Catheter Ablation for Atrial Fibrillation
A study testing Radiofrequency ablation in people with Atrial Fibrillation - Symptomatic, run by Ohad Ziv at 1 site in United States.
Trial summary
A two-pronged approach to evaluate long term success of non-paroxysmal ablation when using a: 1. specified low voltage-directed with pulmonary vein isolation (LD+PVI) approach compared to , 2. an approach of pulmonary vein isolation (PVI) alone. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation - Symptomatic
- What is being tested?
- Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2019to 31 Dec 2027
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria:
- Non-Paroxysmal Atrial Fibrillation.
- Failed or intolerable to at least 1 one antiarrhythmic drug (AAD).
- 18-85 year of age at time of consent.
- Scheduled to undergo a clinically indicated AF ablation procedure.
- Able and willing to comply with all protocol visit requirements.
- Signed Patient Informed Consent (ICF).
- Presence of low voltage in the left atrium on 3-D map during index catheter ablation procedure
Who cannot join
- Subjects will be excluded if any of the follow criteria are present:
- History of prior left-sided catheter or surgical ablation for AF or atypical atrial flutter, including MAZE or mini MAZE.
- Prior ablation for typical atrial flutter or left-sided ablation for WPW, AV node reentry tachycardia or focal ectopic atrial tachycardia may be included.
- Uncontrolled heart Failure or NYHA Class IIIb or IV heart failure.
- Ejection Fraction < 0.20.
- Active ventricular tachycardia requiring treatment with catheter ablation or anti-arrhythmic drug within the last 6 months.
Show all 23Show fewer
- Left atrial size > 60 mm diameter on echocardiogram.
- "Long standing" persistent AF defined as > or = 1 year of continuous atrial fibrillation at the time of enrollment.
- Severe pulmonary hypertension (PAP > 70 mmHg)
- Unstable valvular disease.
- AF secondary to electrolyte imbalance, thyroid disease or reversible non- cardiac cause.
- Poor candidate for general anesthesia.
- Anticipated survival < 1 year.
- MI or CABG within 3 months.
- Left atrial thrombus in pre-procedure imaging within 4 weeks of the ablation procedure.
- Any documented thromboembolic event within 6 months of the ablation procedure.
- Contraindication to anticoagulation.
- Inability to have implantable monitoring device for atrial fibrillation burden with no pre-existing cardiac device that can monitor atrial arrhythmias OR inability to wear external Holter Monitor continuously for 4 weeks.
- Significant congenital anomaly or medical condition that may affect the integrity of study data.
- Women who are pregnant - pregnancy test required if pre-menopausal or non-sterile.
- Active enrollment in another investigational study involving a drug or device.
- Inability to undergo complete voltage mapping in normal sinus rhythm - see intraprocedural protocol.
- Presence of any medical or psychological condition or medical non-compliance history that may adversely impact study outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MetroHealth Medical Center
Cleveland, Ohio, 44109
Peter Leo BS, RN, 216-778-2714, pleo@metrohealth.org
About this study
Official title: Prospective, Multi-center, Randomized, Evaluation Comparing the Protocol Specified Ablation Approach to the Current Standardized Ablation Approach in the Treatment of Non-paroxysmal Atrial Fibrillation.
A two-pronged approach to evaluate long term success of non-paroxysmal ablation when using a:
- specified low voltage-directed with pulmonary vein isolation (LD+PVI) approach compared to ,
- an approach of pulmonary vein isolation (PVI) alone.
Read the detailed description
Patients that meet both inclusion and exclusion criteria will be randomized by the study clinical center upon determination of low-voltage being present using 3-D mapping during index. Enrolled subjects who do not have low voltage will be followed in a registry and their data will be evaluated separately. Low-voltage patients will be randomized 1:1 into one of the following arms:
- PVI with additional total left atrial low voltage-directed ablation.
- PVI alone.
All patients will receive the best conventional medical therapy and anticoagulation use based upon HRS consensus recommendations taking into account their baseline risk factors for stroke. The need for interruption of anticoagulation and antiarrhythmic drug therapy for the procedure will be determined by the operator and their center guidelines.
The trial requires continuous monitoring for atrial arrhythmias. Investigators will recommend the use of implantable loop recorders (ILR) but continuous 30 day monitoring with auto-trigger function may be substituted at the 6, 9 and 12 month time points. The ILR device will be implanted under sterile conditions at the manufacture's recommended site on the precordium for arrhythmia monitoring. Implantation will occur between 1 month prior and 3 months post ablation since there will be a 3 month post ablation blanking period. If a dual chamber device is already present, implantation will not be required. iWatch, Kardia or other non-FDA approved cardiac monitoring can be used to preliminarily identify AF recurrence but AF recurrence must be separately verifiable by ECG or other FDA-certified monitoring system.
One year follow-up is planned. Post procedure care is per standard of care with follow-up at 1 month, 3 months, 6 months, 9 months and 12 months. ECG at every follow-up is performed. Download of arrhythmia data will occur at each of these visits as well. Investigators will use the typical post ablation blanking period for recurrence of atrial fibrillation of 3 months. Antiarrhythmic medications can be used during the typical "blanking period" of 3 months post procedure. But per protocol are stopped at 3 months post procedure (2 months post procedure in case of amiodarone).
Investigators will compare time freedom from first arrhythmia event, defined as a sustained episode of atrial fibrillation or atrial tachycardia. Secondary endpoints will be compared as well (see secondary end point defined). Re-initiation of an antiarrhythmic drug after 3 months will be considered a failure of primary endpoint of arrhythmia free survival. However, Anti-arrhythmic medication use after the blanking period for ventricular arrhythmias will not be included as an event. Anticoagulation is continued and monitored based on previous guidelines with use stratified by baseline stroke risk. A recording (CD) of the mapping during the procedure is to be obtained and retained for possible future analysis.
- Conditions
- Atrial Fibrillation - Symptomatic
- Being tested
- Radiofrequency ablation
- Keywords
- Persistent atrial fibrillation, Medication refractory atrial fibrillation, Pulmonary vein isolation procedure, Low voltage directed ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationProcedure or surgery
Also called Pulmonary vein isolation, low-voltage ablation
Ablation procedure to eliminate atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary vein isolation (PVI) alone | Active comparator | Radiofrequency ablation procedure to isolate pulmonary veins without other intervention performed.. Receives: Procedure: Radiofrequency ablation |
| PVI+Total LT Atrial low voltage ablation | Active comparator | PVI radiofrequency ablation along with ablation of areas of "low voltage" identified. Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from first arrhythmia recurrence defined as sustained symptomatic or asymptomatic atrial fibrillation, atrial flutter or atrial tachycardia.
The primary endpoint is freedom from sustained symptomatic or asymptomatic atrial arrhythmia (atrial fibrillation, atrial flutter or atrial tachycardia - AT/AF) i.e.; NO change from sinus rhythm to atrial arrhythmia between 3 -12 months after ablation. Recurrence of AF/AT excludes the 3 month blanking period. Sustained AF/AT is defined as >30 seconds as recorded on a monitoring device.
Measured: Any event between the 3 month blanking period and 1 year post-ablation.
Secondary outcomes (4)
Reduced arrhythmia burden (frequency that arrhythmia occurs).
Comparison of arrhythmia burden as determined by the composite percent of atrial arrhythmia during the total time recorded on implantable monitoring devices.
Measured: Between the 3 month blocking period and 1 year post-ablation.
Freedom from sustained AF/AT
Freedom from sustained AF/AT is defined as >30 seconds as recorded on a monitoring device.
Measured: Any event between the 3 month blocking period and 1 year post-ablation.
Freedom from any symptomatic AF/AT
Freedom from any symptomatic AF/AT is defined regardless of duration as recorded on a monitoring device.
Measured: Any event between the 3 month blocking period and 1 year post-ablation.
Reduced need for antiarrhythmic drugs (AAD)
Comparison of the use of AAD therapy to control atrial arrhythmias after a successful ablation.
Measured: Any event between the 3 month blocking period and 1 year post-ablation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start14 Jul 2019
- Primary completion31 May 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation - SymptomaticStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized comparison of two ablation techniques: 1. Pulmonary vein isolation (PVI) alone to 2. PVI plus total left atrial low voltage-directed ablation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohad Ziv
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor-investigator, Ohad Ziv, MetroHealth Medical Center
- Investigators
- Ohad Ziv, MD, Principal investigator, MetroHealth System, Ohio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355456
- Sponsor's protocol ID
- IRB17-00025
- Status last verified
- Jun 2024
- First submitted
- 16 Nov 2017
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.
PubMed 24685669Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D. 2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design. J Interv Card Electrophysiol. 2012 Mar;33(2):171-257. doi: 10.1007/s10840-012-9672-7.
PubMed 22382715Themistoclakis S, Raviele A, China P, Pappone C, De Ponti R, Revishvili A, Aliot E, Kuck KH, Hoff PI, Shah D, Almendral J, Manolis AS, Chierchia GB, Oto A, Vatasescu RG, Sinkovec M, Cappato R; Atrial Fibrillation Survey Investigators. Prospective European survey on atrial fibrillation ablation: clinical characteristics of patients and ablation strategies used in different countries. J Cardiovasc Electrophysiol. 2014 Oct;25(10):1074-81. doi: 10.1111/jce.12462. Epub 2014 Jul 8.
PubMed 24891043Lin YJ, Chang SL, Lo LW, Hu YF, Chong E, Chao TF, Chung FP, Liao J, Li CH, Tsao HM, Kao T, Chen YY, Huang JL, Chen SA. A prospective and randomized comparison of limited versus extensive atrial substrate modification after circumferential pulmonary vein isolation in nonparoxysmal atrial fibrillation. J Cardiovasc Electrophysiol. 2014 Aug;25(8):803-812. doi: 10.1111/jce.12407. Epub 2014 Apr 9.
PubMed 24628987Nademanee K, McKenzie J, Kosar E, Schwab M, Sunsaneewitayakul B, Vasavakul T, Khunnawat C, Ngarmukos T. A new approach for catheter ablation of atrial fibrillation: mapping of the electrophysiologic substrate. J Am Coll Cardiol. 2004 Jun 2;43(11):2044-53. doi: 10.1016/j.jacc.2003.12.054.
PubMed 15172410Hwang C, Chen PS. Ligament of Marshall: why it is important for atrial fibrillation ablation. Heart Rhythm. 2009 Dec;6(12 Suppl):S35-40. doi: 10.1016/j.hrthm.2009.08.034.
PubMed 19959141
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center, Randomized, Evaluation Comparing the Protocol Specified Ablation Approach to the Current Standardized Ablation Approach in the Treatment of Non-paroxysmal Atrial Fibrillation.
- ClinicalTrials.gov ID
- NCT03355456
- Acronym / sponsor ID
- IRB17-00025
- Conditions
- Atrial Fibrillation - Symptomatic
- Keywords
- Persistent atrial fibrillation, Medication refractory atrial fibrillation, Pulmonary vein isolation procedure, Low voltage directed ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Ohad ZivUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- 14 Jul 2019 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Nov 2017 (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.
A two-pronged approach to evaluate long term success of non-paroxysmal ablation when using a:
- specified low voltage-directed with pulmonary vein isolation (LD+PVI) approach compared to ,
- an approach of pulmonary vein isolation (PVI) alone.
Detailed description
Patients that meet both inclusion and exclusion criteria will be randomized by the study clinical center upon determination of low-voltage being present using 3-D mapping during index. Enrolled subjects who do not have low voltage will be followed in a registry and their data will be evaluated separately. Low-voltage patients will be randomized 1:1 into one of the following arms:
- PVI with additional total left atrial low voltage-directed ablation.
- PVI alone.
All patients will receive the best conventional medical therapy and anticoagulation use based upon HRS consensus recommendations taking into account their baseline risk factors for stroke. The need for interruption of anticoagulation and antiarrhythmic drug therapy for the procedure will be determined by the operator and their center guidelines.
The trial requires continuous monitoring for atrial arrhythmias. Investigators will recommend the use of implantable loop recorders (ILR) but continuous 30 day monitoring with auto-trigger function may be substituted at the 6, 9 and 12 month time points. The ILR device will be implanted under sterile conditions at the manufacture's recommended site on the precordium for arrhythmia monitoring. Implantation will occur between 1 month prior and 3 months post ablation since there will be a 3 month post ablation blanking period. If a dual chamber device is already present, implantation will not be required. iWatch, Kardia or other non-FDA approved cardiac monitoring can be used to preliminarily identify AF recurrence but AF recurrence must be separately verifiable by ECG or other FDA-certified monitoring system.
One year follow-up is planned. Post procedure care is per standard of care with follow-up at 1 month, 3 months, 6 months, 9 months and 12 months. ECG at every follow-up is performed. Download of arrhythmia data will occur at each of these visits as well. Investigators will use the typical post ablation blanking period for recurrence of atrial fibrillation of 3 months. Antiarrhythmic medications can be used during the typical "blanking period" of 3 months post procedure. But per protocol are stopped at 3 months post procedure (2 months post procedure in case of amiodarone).
Investigators will compare time freedom from first arrhythmia event, defined as a sustained episode of atrial fibrillation or atrial tachycardia. Secondary endpoints will be compared as well (see secondary end point defined). Re-initiation of an antiarrhythmic drug after 3 months will be considered a failure of primary endpoint of arrhythmia free survival. However, Anti-arrhythmic medication use after the blanking period for ventricular arrhythmias will not be included as an event. Anticoagulation is continued and monitored based on previous guidelines with use stratified by baseline stroke risk. A recording (CD) of the mapping during the procedure is to be obtained and retained for possible future analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized comparison of two ablation techniques: 1. Pulmonary vein isolation (PVI) alone to 2. PVI plus total left atrial low voltage-directed ablation.
| Arm | Type | Receives |
|---|---|---|
| Pulmonary vein isolation (PVI) alone | Active comparator | Procedure: Radiofrequency ablationRadiofrequency ablation procedure to isolate pulmonary veins without other intervention performed.. |
| PVI+Total LT Atrial low voltage ablation | Active comparator | Procedure: Radiofrequency ablationPVI radiofrequency ablation along with ablation of areas of "low voltage" identified. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Non-Paroxysmal Atrial Fibrillation.
- Failed or intolerable to at least 1 one antiarrhythmic drug (AAD).
- 18-85 year of age at time of consent.
- Scheduled to undergo a clinically indicated AF ablation procedure.
- Able and willing to comply with all protocol visit requirements.
Key exclusion criteria (23 listed)
- History of prior left-sided catheter or surgical ablation for AF or atypical atrial flutter, including MAZE or mini MAZE.
- Uncontrolled heart Failure or NYHA Class IIIb or IV heart failure.
- Ejection Fraction < 0.20.
- Active ventricular tachycardia requiring treatment with catheter ablation or anti-arrhythmic drug within the last 6 months.
- Left atrial size > 60 mm diameter on echocardiogram.
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 |
|---|---|---|
| Radiofrequency ablationAlso: Pulmonary vein isolation, low-voltage ablationAblation procedure to eliminate atrial fibrillation | Procedure or surgery | PVI+Total LT Atrial low voltage ablation, Pulmonary vein isolation (PVI) alone |
Primary outcome
Freedom from first arrhythmia recurrence defined as sustained symptomatic or asymptomatic atrial fibrillation, atrial flutter or atrial tachycardia.
Time frame: Any event between the 3 month blanking period and 1 year post-ablation.
The primary endpoint is freedom from sustained symptomatic or asymptomatic atrial arrhythmia (atrial fibrillation, atrial flutter or atrial tachycardia - AT/AF) i.e.; NO change from sinus rhythm to atrial arrhythmia between 3 -12 months after ablation. Recurrence of AF/AT excludes the 3 month blanking period. Sustained AF/AT is defined as >30 seconds as recorded on a monitoring device.
4 secondary outcomes
Reduced arrhythmia burden (frequency that arrhythmia occurs).
Time frame: Between the 3 month blocking period and 1 year post-ablation.
Freedom from sustained AF/AT
Time frame: Any event between the 3 month blocking period and 1 year post-ablation.
Freedom from any symptomatic AF/AT
Time frame: Any event between the 3 month blocking period and 1 year post-ablation.
Reduced need for antiarrhythmic drugs (AAD)
Time frame: Any event between the 3 month blocking period and 1 year post-ablation.
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 10 Jun 2024.
- Background: PubMed 24685669January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014 Dec 2;64(21):e1-76. doi: 10.1016/j.jacc.2014.03.022. Epub 2014 Mar 28. No abstract available.
- Background: PubMed 22382715Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D. 2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design. J Interv Card Electrophysiol. 2012 Mar;33(2):171-257. doi: 10.1007/s10840-012-9672-7.
- Background: PubMed 24891043Themistoclakis S, Raviele A, China P, Pappone C, De Ponti R, Revishvili A, Aliot E, Kuck KH, Hoff PI, Shah D, Almendral J, Manolis AS, Chierchia GB, Oto A, Vatasescu RG, Sinkovec M, Cappato R; Atrial Fibrillation Survey Investigators. Prospective European survey on atrial fibrillation ablation: clinical characteristics of patients and ablation strategies used in different countries. J Cardiovasc Electrophysiol. 2014 Oct;25(10):1074-81. doi: 10.1111/jce.12462. Epub 2014 Jul 8.
- Background: PubMed 24628987Lin YJ, Chang SL, Lo LW, Hu YF, Chong E, Chao TF, Chung FP, Liao J, Li CH, Tsao HM, Kao T, Chen YY, Huang JL, Chen SA. A prospective and randomized comparison of limited versus extensive atrial substrate modification after circumferential pulmonary vein isolation in nonparoxysmal atrial fibrillation. J Cardiovasc Electrophysiol. 2014 Aug;25(8):803-812. doi: 10.1111/jce.12407. Epub 2014 Apr 9.
- Background: PubMed 15172410Nademanee K, McKenzie J, Kosar E, Schwab M, Sunsaneewitayakul B, Vasavakul T, Khunnawat C, Ngarmukos T. A new approach for catheter ablation of atrial fibrillation: mapping of the electrophysiologic substrate. J Am Coll Cardiol. 2004 Jun 2;43(11):2044-53. doi: 10.1016/j.jacc.2003.12.054.
- Background: PubMed 19959141Hwang C, Chen PS. Ligament of Marshall: why it is important for atrial fibrillation ablation. Heart Rhythm. 2009 Dec;6(12 Suppl):S35-40. doi: 10.1016/j.hrthm.2009.08.034.
- 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.
Ohad Ziv, MD principal investigator
MetroHealth System, Ohio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation in people with Atrial Fibrillation - Symptomatic, run by Ohad Ziv at 1 site in United States.
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 8 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 10 Jun 2024. 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 United States. 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?
Contact Peter Leo BS, RN (216-778-2714, pleo@metrohealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from first arrhythmia recurrence defined as sustained symptomatic or asymptomatic atrial fibrillation, atrial flutter or atrial tachycardia. (time frame: Any event between the 3 month blanking period and 1 year post-ablation.). 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 NCT03355456, which also lists 6 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 10 Jun 2024.