Safety and Efficacy of Radiofrequency Catheter Ablation of Atrial Fibrillation Drivers as Identified by Fractionated Atrial Potentials (FrAP) Mapping, Using the Rhythmia 3-D Mapping System in Patients with Recurrent Atrial Fibrillation After Prior Pulmonary Vein Isolation Procedure

Safety and Efficacy of Radiofrequency Catheter Ablation of Atrial Fibrillation Drivers as Identified by Fractionated Atrial Potentials (FrAP) Mapping, Using the Rhythmia 3-D Mapping System in Patients with Recurrent Atrial Fibrillation After Prior Pulmonary Vein Isolation Procedure - FrAP- Ablation Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000044793

Enrollment

150

Registered

2021-08-01

Start date

2021-08-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

atrial fibrillation

Interventions

In addition to pulmonary vein re-isolation, Frap ablation is performed.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) patients, having histories of prior catheter ablation (mainly PV isolation), with Symptomatic atrial fibrillation. 2) Documentation of AF between the previous session and the enrollment of the study. 3) Refractory or intolerent to antiarrhythmic drugs.

Exclusion criteria

Exclusion criteria: 1)Initial procedure failed to isolate one or more PVs 2)Left atrial size > 6.1 cm (Anterior-Posterior Dimension) 3)LVEF <35 % 4)Severe mitral regurgitation 5)Prior mitral valve surgery with mechanical valve replacement 6)Intracardiac thrombus present on pre-procedure TTE, TEE. or CT 7)Preexisting severe pulmonary vein stenosis (>75% narrowing) 8)Comorbidity with life-expectancy < 2 years 9)Unable to be on anticoagulation for the purpose of stroke prevention 10)Untreated thyroild dysfunction 11)End-stage renal disease (eGFR<15 or requirement of hemodialysis)

Design outcomes

Primary

Measure	Time frame
Freedom from atrial fibrillation, atrial flutter or atrial tachycardia during 1-year after catheter ablation procedure.	—

Countries

Japan,North America

Contacts

Public ContactYuichiro Sakamoto

Toyohashi Heart Center Cardiovascular medicine

sakamoto@heart-center.or.jp0532373377

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026