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

July 19, 2018 updated by: Minglong Chen, The First Affiliated Hospital with Nanjing Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PVAM
pulomonary vein antrum modification with contact force monitoring for AF
Procedure: pulmonary vein antrum modification
Active Comparator: Control arm
pulmonary vein isolation without contact force
Procedure: pulmonary vein antrum modification

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
procedure time
Time Frame: time during patient enrollment
time that the patient spend in the procedure room
time during patient enrollment
x ray time
Time Frame: time during patient enrollment
x ray spent during the procedure
time during patient enrollment
adverse event
Time Frame: at least 18 months follow up
at least 18 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

December 27, 2016

First Submitted That Met QC Criteria

January 17, 2017

First Posted (Estimate)

January 20, 2017

Study Record Updates

Last Update Posted (Actual)

July 20, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJ01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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