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

NeuroTherapia, Inc.

Status: Active, not recruiting

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: RHYTHMIA; Device: CARTO

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04835844

IRB 20-461

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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).

Trial design

49 participants in 2 patient groups

Mapping with CARTO

Description:

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

Treatment:

Device: CARTO

Mapping with RHYTHMIA

Description:

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

Treatment:

Device: RHYTHMIA