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Clinical Trials/JPRN-UMIN000044793
JPRN-UMIN000044793
Completed
未知

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

Toyohashi Heart Center0 sites150 target enrollmentAugust 1, 2021

Overview

Phase
未知
Intervention
Not specified
Conditions
atrial fibrillation
Sponsor
Toyohashi Heart Center
Enrollment
150
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 1, 2021
End Date
January 31, 2025
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

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)

Outcomes

Primary Outcomes

Not specified

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