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OpenTrials
Completed

NCT Number: NCT03026413

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

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.

Completed

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Vein Isolation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pulmonary vein antrum modification

Procedure

Primary outcomes

  1. any recorded atrial arrhythmias proved by 7-day holter

    Time frame: at least 18 months follow up

    sustained at least 30s

Secondary outcomes

  1. procedure time

    Time frame: time during patient enrollment

    time that the patient spend in the procedure room

  2. x ray time

    Time frame: time during patient enrollment

    x ray spent during the procedure

  3. adverse event

    Time frame: at least 18 months follow up

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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

Acronym: FORCE-PVA

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 20, 2017
Registry last updated
Jul 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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