CAPA-VU Trial Catheter Ablation in Paroxymal Atrial Fibrillation Based on UNIVU (CAPA-VU)
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CartoUnivu™
Ablation with Carto® 3 System
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Paroxysmal Atrial Fibrillation
Eligibility Criteria
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
Sites / Locations
- Herzzentrum der Universität zu Köln
- Universitätsklinikum Hamburg-Eppendorf
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Ablation with Carto® 3 System
Ablation CartoUnivu™
Arm Description
Ablation with Carto® 3 System
Ablation CartoUnivu™
Outcomes
Primary Outcome Measures
Radiation duration
Reduction of radiation duration during ablation
Secondary Outcome Measures
procedure duration
Reduction of procedure duration during ablation
Full Information
NCT ID
NCT03198858
First Posted
April 18, 2016
Last Updated
April 28, 2019
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
Biosense Webster, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03198858
Brief Title
CAPA-VU Trial Catheter Ablation in Paroxymal Atrial Fibrillation Based on UNIVU
Acronym
CAPA-VU
Official Title
CAPA-VU Trial Catheter Ablation in Paroxymal Atrial Fibrillation Based on UNIVU
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
Biosense Webster, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
Catheter ablation (CA) has been established as a standard treatment especially in the setting of symptomatic paroxysmal atrial fibrillation (PAF) by means of pulmonary vein isolation (PVI) as recommended in the current guidelines. However, limitations regarding the success rate but also the x-ray burden with regard to patient and operator remain. One of the fundamental disadvantages of CA as it is routinely performed today, based on sequential application of radiofrequency current (RFC), is the need to verify the catheter position throughout the procedure by using fluoroscopy. Catheter guidance in the left atrium has been facilitated by the introduction of three-dimensional mapping systems allowing catheter localization by either weak magnetic or electrical fields with a consecutive reduction of fluoroscopy burden. Nevertheless, despite these 3D mapping systems the fluoroscopy exposure to patient and particularly electrophysiologists is considerable over time. Potential complications associated with radiation exposure include acute and subacute skin injury as well as radiation-induced cancer and genetic abnormalities.
Recently, a new image integration module (IIM, CartoUnivu™ Module) has been introduced allowing the combination and integration of fluoroscopic images within the 3D electroanatomic map. Thus, an accurate navigation without the use of fluoroscopy after acquisition of a left atrial (LA) angiography is possible throughout the procedure. This implies the generation of the 3D left atrial map and catheter navigation for mapping and ablation.
The potential benefit of the new image integration module has been showing the recent pilot study.
The procedural endpoint is the unexcitability of the ablation line after isolation of the pulmonary veins, as described in detail previously. Catheter manipulation should be guided by 3D mapping if safe and feasible to minimize fluoroscopy time in both groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
Paroxysmal Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ablation with Carto® 3 System
Arm Type
Other
Arm Description
Ablation with Carto® 3 System
Arm Title
Ablation CartoUnivu™
Arm Type
Other
Arm Description
Ablation CartoUnivu™
Intervention Type
Procedure
Intervention Name(s)
CartoUnivu™
Intervention Description
Ablation with Carto® 3 System and image integration module = IIM, CartoUnivu™
Intervention Type
Procedure
Intervention Name(s)
Ablation with Carto® 3 System
Intervention Description
usual Pulmonary vein isolation Ablation with Carto® 3 System only
Primary Outcome Measure Information:
Title
Radiation duration
Description
Reduction of radiation duration during ablation
Time Frame
1 year follow up
Secondary Outcome Measure Information:
Title
procedure duration
Description
Reduction of procedure duration during ablation
Time Frame
1 year follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Willems, MD
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herzzentrum der Universität zu Köln
City
Cologne
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CAPA-VU Trial Catheter Ablation in Paroxymal Atrial Fibrillation Based on UNIVU
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