RHYTHMIA vs CARTO in Redo Ablation Procedures for Atrial Fibrillation

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04835844

Acronym

MAP-AF

Enrollment

Registered

2021-04-08

Start date

2020-07-24

Completion date

2025-07-11

Last updated

2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Atrial Fibrillation

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.

Interventions

DEVICECARTO

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

DEVICERHYTHMIA

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAyman Hussein, MD

The Cleveland Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026