The Comparison Between the PVAM and CPVI for the Patients of PAF (FORCE-PVA)
Primary Purpose
Atrial Fibrillation, Pulmonary Vein Isolation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pulmonary vein antrum modification
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, pulmonary vein isolation, Contact Force, antrum
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PVAM
Control arm
Arm Description
pulomonary vein antrum modification with contact force monitoring for AF
pulmonary vein isolation without contact force
Outcomes
Primary Outcome Measures
any recorded atrial arrhythmias proved by 7-day holter
sustained at least 30s
Secondary Outcome Measures
procedure time
time that the patient spend in the procedure room
x ray time
x ray spent during the procedure
adverse event
Full Information
NCT ID
NCT03026413
First Posted
December 27, 2016
Last Updated
July 19, 2018
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03026413
Brief Title
The Comparison Between the PVAM and CPVI for the Patients of PAF
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Pulmonary Vein Isolation
Keywords
atrial fibrillation, pulmonary vein isolation, Contact Force, antrum
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PVAM
Arm Type
Experimental
Arm Description
pulomonary vein antrum modification with contact force monitoring for AF
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
pulmonary vein isolation without contact force
Intervention Type
Procedure
Intervention Name(s)
pulmonary vein antrum modification
Primary Outcome Measure Information:
Title
any recorded atrial arrhythmias proved by 7-day holter
Description
sustained at least 30s
Time Frame
at least 18 months follow up
Secondary Outcome Measure Information:
Title
procedure time
Description
time that the patient spend in the procedure room
Time Frame
time during patient enrollment
Title
x ray time
Description
x ray spent during the procedure
Time Frame
time during patient enrollment
Title
adverse event
Time Frame
at least 18 months follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23515263
Citation
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 Arrhythm Electrophysiol. 2013 Apr;6(2):327-33. doi: 10.1161/CIRCEP.113.000374. Epub 2013 Mar 20.
Results Reference
result
PubMed Identifier
22820056
Citation
Reddy VY, Shah D, Kautzner J, Schmidt B, Saoudi N, Herrera C, Jais 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 fibrillation in the TOCCATA study. Heart Rhythm. 2012 Nov;9(11):1789-95. doi: 10.1016/j.hrthm.2012.07.016. Epub 2012 Jul 20.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/22820056
Description
an article about the contact force role in ablation for AF
Learn more about this trial
The Comparison Between the PVAM and CPVI for the Patients of PAF
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