Persistent AF Catheter Ablation: Re-PVI Vs. Re-PVI + Continuous Complex Activity Mapping and Ablation - AF-CAM

NCT05496088 | Completed

• 1 other identifier: #3759
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 3

Brief Summary

Major objective is to compare the efficacy of adding additional ablation step (targeting areas of complex, continuous electrical activity in LA) beyond Re-PVI during catheter ablation of Atrial Fibrillation (AF) in patients undergoing 2nd ablation procedure. Underlying hypothesis that in addition, to Re-PVI, an ablation step targeting areas of complex continuous activity will increase atrial arrhythmias freedom compared to Re-PVI only ablation.

Conditions

Atrial Fibrillation

Keywords

Ablation strategy

Outcome Measures

Primary Outcomes (1)

• Freedom from atrial arrhythmia

  Freedom from any form of sustained atrial arrhythmia (\>30 s) follow-up on either a 12 lead ECG on visits or on 48h holter monitoring or on symptom driven event monitoring

  through 3 to 12 months

Study Arms (2)

Group 1: Re-PVI only

ACTIVE COMPARATOR

Repeat ablation of pulmonary veins (Re-PVI), followed by electrical cardioversion if AF persists, n=100 pts

Procedure: Re-PVI only

Group 2: Re-PVI + substrate ablation

ACTIVE COMPARATOR

Repeat ablation of pulmonary veins (Re-PVI) + mapping \& ablation of areas of continuous, complex activity, n=100 pts

Procedure: Re-PVI only; Procedure: Re-PVI + substrate ablation

Interventions

Re-PVI only PROCEDURE

Comparison of two treatment strategies of persistent AF catheter ablation: Re-PVI vs. Re-PVI + continuous complex activity mapping and ablation.

Also known as: Repeat-PVI followed by electrocardioversion if AF persists

Group 1: Re-PVI only; Group 2: Re-PVI + substrate ablation

Re-PVI + substrate ablation PROCEDURE

Comparison of two treatment strategies of persistent AF catheter ablation: Re-PVI vs. Re-PVI + continuous complex activity mapping and ablation.

Also known as: Repeat-PVI followed by mapping & ablation of areas of continuous, complex activity

Group 2: Re-PVI + substrate 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:

• Patients with persistent atrial fibrillation, defined as atrial fibrillation which is:
• Sustained beyond 7 days but no more than one year.
• Or lasting less than 7 days, but with at least one episode longer than 48 h and necessitating pharmacologic or electrical cardioversion.
• Documentation of atrial fibrillation on either a 12-lead ECG or ambulatory holter monitoring or telemetry strip.
• One previous PVI only procedure in 3 years previous, but not within the last 3 months.
• Age 18 - 80 years.
• Patient is willing to participate in the study (signed written informed consent)
• Patient is willing and available to perform all follow ups.

You may not qualify if:

• Atrial fibrillation due to reversible causes.
• Continuous AF \> 12 months.
• Any cardiac surgery within the past 2 months (60 days).
• Documented LA thrombus on imaging.
• LA size \>60 mm.
• Contraindication to anticoagulation (heparin or warfarin).
• Myocardial infarction within the past 2 months (60 days).
• Documented thromboembolic event (including TIA) within the past 12 months.
• Rheumatic Heart Disease.
• Uncontrolled heart failure or NYHA function class III or IV.
• Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days).
• Unstable angina.
• Acute illness or active systemic infection or sepsis.
• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• Diagnosed atrial myxoma.

Sponsors & Collaborators

• Asklepios proresearch: lead
• Asklepios Klinik St. Georg: collaborator

Study Sites (3)

Vivantes - Klinikum Am Urban

Berlin, 10967, Germany

Location

Evangelisches Krankenhaus Duesseldorf

Düsseldorf, 40217, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a prospective, randomized, open-label, blinded endpoint, multi-center study to compare the efficacy of adding additional ablation step (targeting areas of complex, continuous electrical activity in LA) beyond Re-PVI during catheter ablation of Atrial Fibrillation (AF) in patients undergoing 2nd ablation procedure. Trial flow Patients fitting the enrollment criteria and signing the informed consent form will be included and will undergo the Redo procedure for catheter ablation of pers. AF. After Re-PVI only patients with ongoing or inducted AF will be randomized. Patients, who do not fulfill this intraprocedural criteria for randomization will not be randomized but be treated as dropouts. Randomization is based on a 1:1 ratio into two study arms: 1. RePVI only: Re-PVI (followed by cardioversion if AF persists) 2. RePVI + substrate ablation: Re-PVI followed by ablation of areas of complex, continuous activity (followed by cardioversion if AF persists).

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: August 11, 2022
• Study Start: June 3, 2021
• Primary Completion: October 31, 2024
• Study Completion: January 31, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

DE (3)