Comparative Effectiveness of Different Techniques for Repeat Ablation of Atrial Fibrillation
NCT ID: NCT06988202
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
630 participants
INTERVENTIONAL
2025-11-30
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Repeat PVI without LA PWI
Pulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI)
A doctor inserts a thin, flexible tube (called a catheter) through a blood vessel, usually in the groin, and guides it to the heart.
Once the catheter is in place, the doctor uses pulsed field electroporation, heat (radiofrequency) or cold (cryoablation) to create small scars in the area where the pulmonary veins connect to the left atrium of the heart.
These scars block the faulty electrical signals that cause AF, helping the heart maintain a normal rhythm.
Repeat PVI with LA PWI
Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI)
PVI with an additional step where the doctor also isolates the back wall (posterior wall) of the left atrium.
Interventions
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Pulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI)
A doctor inserts a thin, flexible tube (called a catheter) through a blood vessel, usually in the groin, and guides it to the heart.
Once the catheter is in place, the doctor uses pulsed field electroporation, heat (radiofrequency) or cold (cryoablation) to create small scars in the area where the pulmonary veins connect to the left atrium of the heart.
These scars block the faulty electrical signals that cause AF, helping the heart maintain a normal rhythm.
Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI)
PVI with an additional step where the doctor also isolates the back wall (posterior wall) of the left atrium.
Eligibility Criteria
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Inclusion Criteria
* One prior PVI ablation procedure \> 3 months prior for persistent AF
* Recurrent paroxysmal or persistent symptomatic AF confirmed on ECG despite prior PVI
* Eligible for repeat ablation procedure
* Willingness to comply with all post-procedural follow-up requirements and to sign informed consent
Exclusion Criteria
* Prior ablation that included non-PVI LA ablation, or more than one prior PVI ablation procedure for persistent AF
* Prior surgical ablation for AF
* Contraindication to systematic anticoagulation
* LA diameter on echocardiogram \> 6.0 cms
* LV ejection fraction \< 35%
* NYHA class III-IV congestive heart failure
* Acute coronary syndrome or coronary artery bypass surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within 3 calendar months prior to consent date
* Enzyme-positive myocardial infarction within the past 3 calendar months prior to consent
* Severe aortic or mitral valvular heart disease eligible for percutaneous or surgical repair/replacement procedures
* Prior valve replacement with mechanical prosthesis
* Angiographic evidence of coronary disease that requires coronary revascularization and with likelihood of undergoing a CABG or PCI in the next 3 calendar months following consent date
* Stroke within 3 calendar months prior to consent date
* Any medical condition likely to limit survival to \< 1 year
* Renal failure requiring dialysis at time of consent
* Pregnancy
* History of non-compliance to medical therapy
* Participation in other clinical trials (observational/lead registries are allowed) without approval from the CCRC
* Inability or unwillingness to provide informed consent
* Resides at such a distance from the enrolling site so travel to follow-up visits would be unusually difficult
* Does not anticipate residing in the vicinity of the enrolling site for the duration of the trial
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Rochester
OTHER
Responsible Party
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Jonathan Steinberg
Research Professor of Medicine
Principal Investigators
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Johnathan Steinberg, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Wojciech Zareba, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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University of Rochester Clinical Cardiovascular Research Center
Rochester, New York, United States
Countries
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Central Contacts
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Other Identifiers
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STUDY00010537
Identifier Type: -
Identifier Source: org_study_id