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CAPA-VU Trial Catheter Ablation in Paroxymal Atrial Fibrillation Based on UNIVU (CAPA-VU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03198858
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : April 30, 2019
Biosense Webster, Inc.
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

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

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Procedure: CartoUnivu™ Procedure: Ablation with Carto® 3 System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: CAPA-VU Trial Catheter Ablation in Paroxymal Atrial Fibrillation Based on UNIVU
Actual Study Start Date : April 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Ablation with Carto® 3 System
Ablation with Carto® 3 System
Procedure: Ablation with Carto® 3 System
usual Pulmonary vein isolation Ablation with Carto® 3 System only

Ablation CartoUnivu™
Ablation CartoUnivu™
Procedure: CartoUnivu™
Ablation with Carto® 3 System and image integration module = IIM, CartoUnivu™

Primary Outcome Measures :
  1. Radiation duration [ Time Frame: 1 year follow up ]
    Reduction of radiation duration during ablation

Secondary Outcome Measures :
  1. procedure duration [ Time Frame: 1 year follow up ]
    Reduction of procedure duration during ablation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03198858

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Herzzentrum der Universität zu Köln
Cologne, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Biosense Webster, Inc.
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Principal Investigator: Stephan Willems, MD Universitätsklinikum Hamburg-Eppendorf

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf Identifier: NCT03198858     History of Changes
Other Study ID Numbers: PV4975
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Paroxysmal Atrial Fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes