RHYTHMIA vs CARTO in Redo Ablation Procedures for Atrial Fibrillation

Paroxysmal Atrial Fibrillation Clinical Trial

— MAP-AF  

Official title:

RHYTHMIA vs CARTO in Redo Ablation Procedures for Atrial Fibrillation: MAP-AF Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04835844
• Other study ID #: IRB 20-461
• Status: Recruiting
• Start date: July 24, 2020
• Est. completion date: July 1, 2026

Study information

• Verified date: May 2024
• Source: The Cleveland Clinic
• Contact: Ayman Hussein, MD
• Phone: 216-444-6171
• Email: husseia[@]ccf.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 1, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• CARTO
Redo-ablation of paroxysmal AF with high density mapping system, CARTO, in conjunction with CONFIDENSE mapping module and PENTARRAY catheter
• RHYTHMIA
Redo-ablation of paroxysmal AF with high density mapping system, RHYTHMIA, in conjunction with the 64-electrodes ORION mini-basket catheter.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	System is able to accurately identify gaps	Incidence of accurate identification of gaps in prior ablation lines by the system	At the time of procedure
Secondary	Treatment success	Freedom from AF recurrence	Up to 12 months