Paroxysmal Atrial Fibrillation Clinical Trial
— CAPA-VUOfficial title:
CAPA-VU Trial Catheter Ablation in Paroxymal Atrial Fibrillation Based on UNIVU
NCT number | NCT03198858 |
Other study ID # | PV4975 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | March 2019 |
Verified date | April 2019 |
Source | Universitätsklinikum Hamburg-Eppendorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 100 |
Est. completion date | March 2019 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age = 18 years - Written informed consent - Symptomatic Paroxysmal Atrial Fibrillation with indication for ablation Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Herzzentrum der Universität zu Köln | Cologne | |
Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf | Biosense Webster, Inc. |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Radiation duration | Reduction of radiation duration during ablation | 1 year follow up | |
Secondary | procedure duration | Reduction of procedure duration during ablation | 1 year follow up |
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