Sign in

NCT06098989Not yet recruiting

A Prospective Study of REPeat Ablation In Patients With Recurrent PERSistent Atrial Fibrillation: Pulmonary Vein Isolation vs. Adjunct Posterior Wall Isolation (REPAIR PERS-AF Study)

Source: ClinicalTrials.gov · Last updated 25 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This study aims to investigate the best strategy for repeat ablation of recurrent persistent atrial fibrillation (AF) after previous persistent AF ablation involving pulmonary vein isolation (PVI) along. Patients with low voltage areas on the posterer wall will be randomized to PVI alone or the posterer wall isoaltion (PWI) in addition to PVI.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
150 (estimated)
First submitted
2 Oct 2023
Start date
15 Nov 2023
Primary completion date
15 Nov 2026
Lead sponsor
Haukeland University Hospital
NCT number
NCT06098989

What you commit to

  • Study type: Interventional
  • Planned participants: 150
  • From 15 Nov 2023 to the primary completion date, 15 Nov 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous ablation procedures for AF involving ablation strategies beyond PVI

Other illness

  • Uncontrolled heart failure
  • Severe valvular disease
  • Structural heart disease involving more than moderate valvular stenosis and/or
  • Rheumatic heart disease
  • Cardiac surgery for valvopathy or for congenital heart disease

Age

  • Duration of persistent AF \>3 years

Other

  • Patients with \>2 ablation procedures in the LA for AF or atrial flutter
  • Presence of atrial flutter or atrial tachycardia
  • Presence of an intracavitary thrombus
  • LA diameter \> 60 mm
  • Insufficiencies
  • Patients with contraindications to systemic anticoagulation
  • Severe renal dysfunction
  • Patients who are or may potentially be pregnant.
  • Patient not able to be followed up.

Who the study is looking for

  • Symptomatic patients with persistent AF and indication for repeat ablation
  • procedure.
  • Patients with recurrent persistent AF (with a duration \<3 year, at least one episode longer than 7 days during the last 6 months and have been electrically cardioverted at least once during the last 12 months) after previous catheter ablation.
  • Patients with up to two previous catheter ablations for AF are included if the procedures only involved PVI. Previous PVI procedure(s) with both cryoablation and radiofrequency ablation are accepted.
  • Patients have taken at least one antiarrhythmic drug.
  • Patients are willing to participate in the study and sign the patient information form.
  • Age: 18-80 years old.
  • Patients must be on continuous anticoagulation with warfarin (INR 2-3) or direct oral anticoagulant for \>4 weeks prior to the ablation.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.