RHYTHMIA vs CARTO in Redo Ablation Procedures for Atrial Fibrillation

Active, not recruiting

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Device: CARTO; Device: RHYTHMIA

• Registration Number: NCT04835844
• Lead Sponsor: The Cleveland Clinic

Brief Summary

The MAP-AF study will compare RHYTHMIA vs CARTO in redo ablation of paroxysmal AF with assessment of both acute procedural profiles and clinical outcomes.

Detailed Description

Pulmonary venous conduction recovery is found in most patients undergoing redo ablation procedures for atrial fibrillation (AF). Identifying gaps in prior ablation lines is essential to achieve successful outcomes. High density mapping systems have been proposed to allow the identification of such gaps with speed and accuracy.

The MAP-AF study will compare RHYTHMIA vs CARTO in redo ablation of paroxysmal AF with assessment of both acute procedural profiles and clinical outcomes.

Study Timeline

• Study Start: 2020-07-24
• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-04-05
• Study First Posted: 2021-04-08
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-12-31
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Adult patients (18-90 years of age) undergoing redo ablation procedures for paroxysmal AF regardless of the systems or energy sources used during the pre-study ablation procedure(s).
• Paroxysmal AF: defined as AF terminating within 7 days of onset either spontaneously or with electrical or medical cardioversion.

Exclusion Criteria

• Persistent AF
• Prior cardiac surgery
• Patients with only AFL or AT as the documented recurrent arrhythmia after the pre-study AF ablation(s).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mapping with CARTO	CARTO	CARTO (Biosense Webster) in conjunction with CONFIDENSE mapping module and PENTARRAY catheter
Mapping with RHYTHMIA	RHYTHMIA	RHYTHMIA (Boston Scientific) in conjunction with the 64-electrodes ORION mini-basket catheter.

Primary Outcome Measures

Name	Time	Method
System is able to accurately identify gaps	At the time of procedure	Incidence of accurate identification of gaps in prior ablation lines by the system

Secondary Outcome Measures

Name	Time	Method
Treatment success	Up to 12 months	Freedom from AF recurrence

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States