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

The First Affiliated Hospital with Nanjing Medical University180 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

180

Conditions

Atrial Fibrillation Pulmonary Vein Isolation

Interventions

pulmonary vein antrum modificationPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

any recorded atrial arrhythmias proved by 7-day holter

sustained at least 30s

Time frame: at least 18 months follow up

Secondary Outcomes

procedure time

time that the patient spend in the procedure room

Time frame: time during patient enrollment

x ray time

x ray spent during the procedure

Time frame: time during patient enrollment

adverse event

Time frame: at least 18 months follow up

Data from ClinicalTrials.gov

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