Pulsed Field Ablation Versus Conventional Radiofrequency Catheter Ablation for Repeat PVI in Patients With Paroxysmal AF

NCT06199180 | Recruiting

• 1 other identifier: REPEAT-AF trial
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

Various methods exist for performing pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF), including thermal ablation and pulse-field ablation (PFA). However, in cases requiring a second PVI for recurrent AF, radiofrequency ablation (RFA) is utilized in nearly 95% of instances post-acquiring a 3D high-density map from the left atrium (LA). Up to 85% of patients experiencing recurrent AF after the initial PVI exhibit pulmonary vein (PV) reconnections, often identified as the cause of AF. PFA has demonstrated its safety and efficiency compared to RFA as a swift technique for performing ablation. Yet, whether PFA or RFA stands out as superior or safer when applied for a second PVI remains unclear, as no randomized controlled trial has investigated this comparison. The proposed REPEAT-AF trial aims to randomize 154 AF patients experiencing recurrent AF after the initial PVI, assigning them in a 1:1 ratio to either RFA or PFA. Each patient will receive an implantable cardiac monitor to precisely detect any AF recurrences.

Conditions

Atrial Fibrillation Recurrent

Keywords

pulmonary vein isolation; pulsed field ablation; radiofrequency ablation; implantable cardiac monitor

Outcome Measures

Primary Outcomes (1)

• To compare the efficacy of repeat pulmonary vein isolation (PVI) with PFA or point-by-point RF ablation.

  12-month incidence of AF/AFl/AT recurrence.

  12 months

Secondary Outcomes (9)

• To compare the efficacy of repeat pulmonary vein isolation (PVI) with PFA or point-by-point RF ablation.

  24 months

• Repeat PVI within 12 and 24 months of randomization

  12 and 24 months

• AF burden with and without 3 months blanking period

  12 and 24 months

• Change in quality of life

  12 and 24 months

• Change in quality of life as affected by AF

  12 and 24 months

Study Arms (2)

Radiofrequency ablation

ACTIVE COMPARATOR

In this group, patients will undergo the acquisition of a 3D high-density map. If pulmonary vein (PV) reconnection is identified, radiofrequency ablation (RFA) will be employed for pulmonary vein isolation (PVI). Should PV reconnection not be detected, the operator will have the discretion to determine the necessary ablation strategies. Patients falling into this category will be included in a concurrent registry.

Device: pulmonary vein isolation with RFA

Pulsed field ablation

EXPERIMENTAL

In this group, pulmonary vein (PV) reconnection is identified by the FARAWAVE system. If reconnection is observed, pulsed field ablation (PFA) will be employed for pulmonary vein isolation (PVI). Should PV reconnection not be detected, the operator will have the discretion to determine the necessary ablation strategies. Patients falling into this category will be included in a concurrent registry.

Device: pulmonary vein isolation with PFA

Interventions

pulmonary vein isolation with RFA DEVICE

Patients randomised to RFA will undergo PVI with point-by-point RFA.

Radiofrequency ablation

pulmonary vein isolation with PFA DEVICE

Patients randomised to PFA will undergo PVI with PFA.

Pulsed field ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient had 1 previous PVI with either cryoballoon, RF ablation or PFA
• Index PVI occurred within \<5 years prior to enrolment
• Documented AF recurrence \>30 seconds
• Symptomatic AF
• Paroxysmal AF
• Age \>18 and \<80 years
• Willing and capable to provide informed consent
• Able and willing to participate in all examinations and follow-up visits and tests associated with this clinical study

You may not qualify if:

• Persistent AF (by diagnosis of duration \>7 days)
• Underwent additional ablations outside the pulmonary veins during index AF ablation
• AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes
• Contraindication to, or unwillingness to use, systematic anticoagulation
• Left ventricular ejection fraction (LVEF) \<30% as documented by transthoracic echo (TTE) (within \<3 months prior)
• Left atrial volume index \>60 ml/m2
• Clinically significant arrhythmias other than AF
• Previous surgery for AF
• New York Heart Association (NYHA) Functional Class III or IV
• Presence of intramural thrombus, tumour or other abnormality that precludes safe catheter introduction or manipulation
• BMI \>35 kg/m2
• Significant or symptomatic hypotension, bradycardia, or chronotropic incompetence
• Chronic renal insufficiency of \<15 mL/min/1.73 m2 or any history of renal dialysis, or history of renal transplant
• Hemodynamically significant valvular disease
• Presence of patent foramen ovale (PFO) or atrial septal defect (ASD) closure device

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

UMCG

Groningen, 9713GZ, Netherlands

RECRUITING

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Yuri Blaauw, Dr.

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuri Blaauw, Dr.

CONTACT

+31503616161; y.blaauw01@umcg.nl

Nick van Vreeswijk, drs.

CONTACT

+31503616161; n.l.van.vreeswijk@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients know their treatment arm. All endpoints will be adjudicated by a blinded endpoint committee.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: patients will be randomised to PFA or RFA for redo PVI

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: January 10, 2024
• Study Start: September 20, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)