CAPA-VU Trial Catheter Ablation in Paroxymal Atrial Fibrillation Based on UNIVU
CAPA-VU
1 other identifier
interventional
100
1 country
2
Brief Summary
CartoUnivu™ module easily integrates into the workflow of PVI with the endpoint of unexcitability of the ablation line without prolonging the procedure time. It is associated with a marked reduction in fluoroscopic dose when compared to a conventional 3D-mapping system. The aim of this prospective randomized study is to evaluate during pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) whether the use of the IIM is: 1. feasible, 2. can help to reduce fluoroscopy time and burden and 3. has an influence on the procedure duration. Study design Prospective, randomized controlled multicenter trial, open label. Randomization 1:1
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2016
Typical duration for not_applicable
2 active sites
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
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 18, 2016
CompletedFirst Posted
Study publicly available on registry
June 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedApril 30, 2019
April 1, 2019
1.9 years
April 18, 2016
April 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Radiation duration
Reduction of radiation duration during ablation
1 year follow up
Secondary Outcomes (1)
procedure duration
1 year follow up
Study Arms (2)
Ablation with Carto® 3 System
OTHERAblation with Carto® 3 System
Ablation CartoUnivu™
OTHERAblation CartoUnivu™
Interventions
Ablation with Carto® 3 System and image integration module = IIM, CartoUnivu™
usual Pulmonary vein isolation Ablation with Carto® 3 System only
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Written informed consent
- Symptomatic Paroxysmal Atrial Fibrillation with indication for ablation
You may not qualify if:
- Age \< 18 years
- Persistent or Permanent Atrial Fibrillation (failed Cardioversion or episode duration \> 12 months)
- Previous surgical or interventional therapy of atrial fibrillation
- BMI \> 30
- Pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment
- History of hemorrhagic diathesis or other coagulopathies
- Contraindications for oral anticoagulation
- Hyper- or hypothyroidism
- Has any condition that would make participation not be in the best interest of the subject
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitätsklinikum Hamburg-Eppendorflead
- Biosense Webster, Inc.collaborator
Study Sites (2)
Herzzentrum der Universität zu Köln
Cologne, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephan Willems, MD
Universitätsklinikum Hamburg-Eppendorf
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Open Label
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2016
First Posted
June 26, 2017
Study Start
April 1, 2016
Primary Completion
March 1, 2018
Study Completion
March 1, 2019
Last Updated
April 30, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share