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

Atrial Fibrillation Clinical Trial

— FORCE-PVA  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03026413
• Other study ID #: NJ01
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: September 2016

Study information

• Verified date: July 2018
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Pulmonary Vein Isolation

Intervention

Procedure:
• pulmonary vein antrum modification

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

References & Publications (2)

Neuzil P, Reddy VY, Kautzner J, Petru J, Wichterle D, Shah D, Lambert H, Yulzari A, Wissner E, Kuck KH. Electrical reconnection after pulmonary vein isolation is contingent on contact force during initial treatment: results from the EFFICAS I study. Circ — View Citation

Reddy VY, Shah D, Kautzner J, Schmidt B, Saoudi N, Herrera C, Jaïs P, Hindricks G, Peichl P, Yulzari A, Lambert H, Neuzil P, Natale A, Kuck KH. The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial f — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	any recorded atrial arrhythmias proved by 7-day holter	sustained at least 30s	at least 18 months follow up
Secondary	procedure time	time that the patient spend in the procedure room	time during patient enrollment
Secondary	x ray time	x ray spent during the procedure	time during patient enrollment
Secondary	adverse event		at least 18 months follow up

External Links

•   an article about the contact force role in ablation for AF