A Global Randomized Trial Evaluating the FARAFLEX™ Mapping and Pulsed Field Ablation System With Electrographic Flow Mapping in Patients Undergoing Repeat Ablation for Atrial Fibrillation

NCT07820930 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: PF340
• Study Type: interventional
• Target: 650
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of the ReDEFINE-AF Clinical Study is to evaluate the safety and effectiveness of the FARAFLEX™ Mapping and Pulsed Field Ablation System with electrographic flow mapping in subjects undergoing repeat ablation for atrial fibrillation (AF).

Conditions

Persistent Atrial Fibrillation (PersAF); Atrial Fibrillation (AF); Paroxysmal Atrial Fibrillation (PAF)

Keywords

Pulsed Field Ablation; Electrographic Flow Mapping; FARAFLEX; OptiMap; Catheter Ablation; EGF; Repeat Ablation; Pulmonary Vein Isolation; Posterior Wall Ablation; ICM

Outcome Measures

Primary Outcomes (1)

• The Primary Effectiveness Endpoint (PEE) is the Proportion of Randomized Subjects in the Main Study Cohort achieving Treatment Success through the Day 365 Assessment.

  The Primary Effectiveness Endpoint analysis will compare Treatment Success between the Treatment Arm and the Control Arm in randomized subjects in the Main Study Cohort.

  Day 180 through Day 365 Assessment

Secondary Outcomes (1)

• The Secondary Safety Endpoint is the rate of protocol-defined device- or procedure-related Composite Serious Adverse Events (CSAE).

  Day 0 through Day 60

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Subjects will undergo EGF mapping using the OptiMap™ Catheter and System, followed by ablation of eligible EGF-identified extra-pulmonary vein sources using the FARAFLEX™ Mapping and PFA System.

Device: FARAFLEX Mapping and Pulsed Field Ablation System

Control Arm

ACTIVE COMPARATOR

Subjects will undergo EGF mapping using the OptiMap™ Catheter and System. For Control Arm subjects who have not previously undergone posterior wall ablation/isolation and who do not have documented durable posterior wall isolation, protocol-defined de novo posterior wall ablation will be performed using the FARAFLEX™ Mapping and PFA System.

Device: FARAFLEX Mapping and Pulsed Field Ablation System

Interventions

FARAFLEX Mapping and Pulsed Field Ablation System DEVICE

Catheter used for electrophysiological mapping of cardiac structures and the treatment of paroxysmal or persistent atrial fibrillation.

Control Arm; Treatment Arm

Eligibility Criteria

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

You may qualify if:

• At least 18 years old, or older if required by local law.
• Subjects with symptomatic atrial fibrillation who have documented Persistent Atrial Fibrillation (PersAD) or Paroxysmal Atrial Fibrillation (PAF) with at least one documented symptomatic AF episode lasting at least 24 hours.
• AND Undergone one failed endocardial atrial fibrillation ablation procedure OR undergone no more than two prior endocardial atrial fibrillation ablation procedures that were both limited to PV and/or PW ablation.
• Willing and capable of providing informed consent.
• Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center.
• Willing to receive a LUX-Dx insertable cardiac monitor (ICM) during the study or already has a LUX-Dx ICM that was inserted within 6 months prior to consent, and willing to comply with the LUX-Dx Latitude Clarity transmission instructions.

You may not qualify if:

• Any of the following atrial conditions:
• Left atrial anteroposterior (LA) diameter ≥ 6.5 cm, or if LA diameter is not available, non-indexed LA volume \>100 mL.
• Current atrial myxoma.
• Current left atrial thrombus.
• Any PV abnormality, stenosis, or stenting. Common and middle PVs are admissible.
• Any of the following cardiovascular conditions:
• History of sustained ventricular tachycardia or any ventricular fibrillation.
• Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data.
• Atrial Fibrillation (AF) that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes.
• Presence of any of the following:
• Current or anticipated pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy device.
• Implantable loop recorder other than a LUX-Dx device
• Interatrial baffle, atrial septal defect or patent foramen ovale closure device or patch
• Left Atrial Appendage Closure or Occlusion Device
• Presence of any of the following:

Sponsors & Collaborators

• Boston Scientific Corporation: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Eliza Lawrence

CONTACT

(650) 215-1267; Eliza.Lawrence@bsci.com

Monika Bushko

CONTACT

(617)218-3963; monika.bushko@bsci.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 15, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2031
• Last Updated: September 28, 2026

Record last verified: 2026-09