The Comparison Between the PVAM and CPVI for the Patients of PAF
FORCE-PVA
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
1 other identifier
interventional
180
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Mar 2015
Shorter than P25 for not_applicable atrial-fibrillation
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 27, 2016
CompletedFirst Posted
Study publicly available on registry
January 20, 2017
CompletedJuly 20, 2018
July 1, 2018
1 year
December 27, 2016
July 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
any recorded atrial arrhythmias proved by 7-day holter
sustained at least 30s
at least 18 months follow up
Secondary Outcomes (3)
procedure time
time during patient enrollment
x ray time
time during patient enrollment
adverse event
at least 18 months follow up
Study Arms (2)
PVAM
EXPERIMENTALpulomonary vein antrum modification with contact force monitoring for AF
Control arm
ACTIVE COMPARATORpulmonary vein isolation without contact force
Interventions
Eligibility Criteria
You may qualify if:
- patients with paroxysmal atrial fibrillation refractory to drugs
- with consent
You may not qualify if:
- LVEF\<50%
- history of cardiac surgery
- valvular heart disease
- abnormal thyroid function
- left atrial thrombus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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 Arrhythm Electrophysiol. 2013 Apr;6(2):327-33. doi: 10.1161/CIRCEP.113.000374. Epub 2013 Mar 20.
PMID: 23515263RESULTReddy 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.
PMID: 22820056RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Director of Cardiac EP Vice Director of Dept. of Cardiology
Study Record Dates
First Submitted
December 27, 2016
First Posted
January 20, 2017
Study Start
March 1, 2015
Primary Completion
March 1, 2016
Study Completion
September 1, 2016
Last Updated
July 20, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share