The Comparison Between the PVAM and CPVI for the Patients of PAF (FORCE-PVA)

Nanjing Medical University

Status: Completed

Conditions: Atrial Fibrillation; Pulmonary Vein Isolation

Treatments: Procedure: pulmonary vein antrum modification

Study type: Interventional

Funder types: Other

Identifiers

NCT03026413

NJ01

Details and patient eligibility

About

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.

Full description

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

Enrollment: 180 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

180 participants in 2 patient groups

PVAM

Experimental group

Description:

pulomonary vein antrum modification with contact force monitoring for AF

Treatment:

Procedure: pulmonary vein antrum modification

Control arm

Active Comparator group

Description:

pulmonary vein isolation without contact force

Treatment:

Procedure: pulmonary vein antrum modification