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

The Comparison Between the Pulmonary Vein Antrum Modification by SmartTouch Ablation Catheter With Contact Force Monitoring and Circumferential Pulmonary Vein Isolation by That Without Contact Force Monitoring Plus Lasso Catheter for the Patients of Paroxysmal Atrial Fibrillation: a Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03026413

Acronym

FORCE-PVA

Enrollment

180

Registered

2017-01-20

Start date

2015-03-31

Completion date

2016-09-30

Last updated

2018-07-20

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

Conditions

Atrial Fibrillation, Pulmonary Vein Isolation

Keywords

atrial fibrillation, pulmonary vein isolation, Contact Force, antrum

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.

Interventions

PROCEDUREpulmonary vein antrum modification

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026