The Comparison Between the PVAM and CPVI for the Patients of PAF

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Pulmonary Vein Isolation
• Interventions: Procedure: pulmonary vein antrum modification

• Registration Number: NCT03026413
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

To compare the efficacy and safety of circumferential pulmonary vein isolation without contact force with the pulmonary vein antrum modification for patients of paroxysmal atrial fibrillation.

Detailed Description

This is a single centre, prospective control study. The study will enroll 180 patients with 2:1 grouped.

Study Timeline

• Study Start: 2015-03
• Primary Completion: 2016-03
• Study Completion: 2016-09
• Study First Submitted: 2016-12-27
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-20
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• patients with paroxysmal atrial fibrillation refractory to drugs
• with consent

Exclusion Criteria

• LVEF<50%
• history of cardiac surgery
• valvular heart disease
• abnormal thyroid function
• left atrial thrombus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVAM	pulmonary vein antrum modification	pulomonary vein antrum modification with contact force monitoring for AF
Control arm	pulmonary vein antrum modification	pulmonary vein isolation without contact force

Primary Outcome Measures

Name	Time	Method
any recorded atrial arrhythmias proved by 7-day holter	at least 18 months follow up	sustained at least 30s

Secondary Outcome Measures

Name	Time	Method
procedure time	time during patient enrollment	time that the patient spend in the procedure room
x ray time	time during patient enrollment	x ray spent during the procedure
adverse event	at least 18 months follow up