RHYTHMIA vs CARTO in Redo Ablation Procedures for Atrial Fibrillation

NCT ID: NCT04835844

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 49 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-24
• Study Completion Date: 2026-07-01

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.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Mapping with CARTO

CARTO (Biosense Webster) in conjunction with CONFIDENSE mapping module and PENTARRAY catheter

CARTO

Intervention Type: DEVICE

Redo-ablation of paroxysmal AF with high density mapping system, CARTO, in conjunction with CONFIDENSE mapping module and PENTARRAY catheter

Mapping with RHYTHMIA

RHYTHMIA (Boston Scientific) in conjunction with the 64-electrodes ORION mini-basket catheter.

RHYTHMIA

Intervention Type: DEVICE

Redo-ablation of paroxysmal AF with high density mapping system, RHYTHMIA, in conjunction with the 64-electrodes ORION mini-basket catheter.

Interventions

CARTO

Redo-ablation of paroxysmal AF with high density mapping system, CARTO, in conjunction with CONFIDENSE mapping module and PENTARRAY catheter

Intervention Type: DEVICE

RHYTHMIA

Redo-ablation of paroxysmal AF with high density mapping system, RHYTHMIA, in conjunction with the 64-electrodes ORION mini-basket catheter.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ayman Hussein, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

IRB 20-461

Identifier Type: -

Identifier Source: org_study_id