RHYTHMIA vs CARTO in Redo Ablation Procedures for Atrial Fibrillation (MAP-AF)

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

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 Overview

• Status: Recruiting
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Device: CARTO; Device: RHYTHMIA

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 Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Ayman Hussein, MD; Phone Number: 216-444-6171; Email: husseia@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Ayman Hussein, MD; Phone Number: 216-444-6171; Email: husseia@ccf.org
      • Principal Investigator: Ayman Hussein, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Electrophysiology clinic patients who are considered candidates for redo paroxysmal AF ablation.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mapping with CARTO; CARTO (Biosense Webster) in conjunction with CONFIDENSE mapping module and PENTARRAY catheter	Device: CARTO; 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.	Device: RHYTHMIA; Redo-ablation of paroxysmal AF with high density mapping system, RHYTHMIA, in conjunction with the 64-electrodes ORION mini-basket catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment success	Freedom from AF recurrence	Up to 12 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Ayman Hussein, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2020
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 25, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: IRB 20-461

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No