Endocardial Vs Epicardial Ablation for Recurrent Paroxysmal AF

Withdrawn before enrolling · Not applicable

Conditions studied: Recurrent Paroxysmal Atrial Fibrillation Despite Prior Pulmonary Vein Isolation

In brief

There is no current accepted and predictably effective ablative therapy for patients with recurrent paroxysmal atrial fibrillation after prior pulmonary vein isolation (PVI). This study will compare redo PVI with hybrid epicardial ablation incorporating posterior wall isolation and LAA clip, and redo PVI.

Key facts

Study ID

NCT04506814

Run by

University of Rochester

People needed

0

Starts

2025-01-01

Expected to finish

2028-01-01

Last updated by the study team

2023-11-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years
• Symptomatic paroxysmal AF despite prior 1 or 2 PVI procedures within past 10 years (paroxysmal AF lasting up to 7 days before spontaneous termination)
• Eligible for referral for re-ablation based on current guidelines
• LA diameter < 6.0 cms on transthoracic echo
• Willingness to comply with post-procedural follow-up requirements and to sign informed consent

You may not qualify if…

• Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to anticoagulation)
• Prior history of open heart surgery
• Prior history of pericarditis or pericardiocentesis
• Prior history of stroke/TIA/systemic embolism
• NYHA class IV congestive heart failure or LVEF < 25%
• Persistent or longstanding persistent AF (duration > 1 year)
• Coronary revascularization or valve surgery within 3 months
• Prior valve surgery using a mechanical prosthesis
• An estimated glomerular filtration rate (eGFR) < 45mL/min/1.73m2, using the MDRD calculation
• Life expectancy <1 year for any medical condition
• AF due to reversible cause e.g. hyperthyroid state
• Women who are pregnant or plan to become pregnant during the course of the trial** Note: Women of childbearing potential must have a negative pregnancy test within 7 days prior to randomization.
• Participation in other clinical trials that will affect the objectives of this study
• History of non-compliance to medical therapy
• 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

Where it is running

• University of Rochester — Short Hills, New Jersey, United States

Full record on ClinicalTrials.gov

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