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

March 26, 2026 updated by: The Cleveland Clinic

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

Completed

Conditions

Intervention / Treatment

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 (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: At the time of procedure
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
Time Frame: Up to 12 months
Freedom from AF recurrence
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Ayman Hussein, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2020

Primary Completion (Actual)

July 11, 2025

Study Completion (Actual)

July 11, 2025

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)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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