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Enrolling by invitation NCT06988202

Comparative Effectiveness of Different Techniques for Repeat Ablation of Atrial Fibrillation

No phase Interventional Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pulmonary Vein Isolation (PVI) without Left Atrial Posterior Wall Isolation (PWI), Pulmonary Vein Isolation (PVI) with Left Atrial Posterior Wall Isolation (PWI).
Who it may be relevant to
Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparative Effectiveness of Different Techniques for Repeat Ablation After Failed Initial Ablation for Persistent Atrial Fibrillation

Overview

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.

Interventions

  • Procedure 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.
  • Procedure 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.

Primary outcome measures

  • Mean Change of Symptom Score on the Atrial Fibrillation Severity Scale (AFSS) [Time frame: From Baseline to Month 12]
Secondary outcome measures (4)
  • Time to First Atrial Fibrillation Episode Lasting > 30 Seconds [Time frame: Up to 24 Months Following Randomization]
  • Mean Total Atrial Fibrillation Burden from Serial Holter Recordings [Time frame: From Randomization through Month 24]
  • Mean Total Number of Cardiovascular Health Care Utilization Events [Time frame: From Randomization through Month 48]
  • Mean Total Number of Major Clinical Events [Time frame: From Randomization through Month 48]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years on date of consent
  • 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

  • Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus)
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

United States · 1 center
  • University of Rochester Clinical Cardiovascular Research Center — Rochester

Identifiers

NCT: NCT06988202 · STUDY00010537

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗