Comparative Effectiveness of Different Techniques for Repeat Ablation of Atrial Fibrillation

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT06988202
Status
Enrolling By Invitation

Conditions

  • Atrial Fibrillation (AF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI) — PROCEDURE
    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) — PROCEDURE
    PVI with an additional step where the doctor also isolates the back wall (posterior wall) of the left atrium.

Study Details

Atrial fibrillation (AF) is the most common type of irregular heartbeat doctors see. People with AF sometimes have a procedure called an ablation to help get their heart back into a normal rhythm. However, this treatment doesn't always work. This study is looking at whether adding an extra step to the usual ablation-specifically treating another area of the heart called the left atrial (LA) posterior wall-can help people feel better overall, compared to just repeating the standard pulmonary vein isolation ablation procedure.

Key Dates

Start date
Mar 18, 2026
Status verified
Mar 2026
Primary completion
Jan 1, 2030
Completion
Dec 31, 2031

Study Design

Enrollment
630 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: Repeat PVI without LA PWI
  • Other: Repeat PVI with LA PWI

Primary Outcome Measure

Mean Change of Symptom Score on the Atrial Fibrillation Severity Scale (AFSS) [ Time Frame: From Baseline to Month 12 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Rochester Clinical Cardiovascular Research CenterRochesterNew York14642-

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By research site
University of Rochester Clinical Cardiovascular Research Center· Rochester, NY

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