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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03198858|
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : June 26, 2017
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|
|Paroxysmal Atrial Fibrillation||Procedure: CartoUnivu™ Procedure: Ablation with Carto® 3 System|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||CAPA-VU Trial Catheter Ablation in Paroxymal Atrial Fibrillation Based on UNIVU|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||April 2018|
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 with Carto® 3 System and image integration module = IIM, CartoUnivu™
- Radiation duration [ Time Frame: 1 year follow up ]Reduction of radiation duration during ablation
- procedure duration [ Time Frame: 1 year follow up ]Reduction of procedure duration during ablation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198858
|Contact: Stephan Willems, MDfirstname.lastname@example.org|
|Contact: Ruken Özge Akbulakemail@example.com|
|Herzzentrum der Universität zu Köln||Recruiting|
|Contact: Jakob Lueker|
|Contact: Elena Terentieva|
|Principal Investigator: Daniel Steven|
|Sub-Investigator: Jakob Lüker|
|Hamburg, Germany, 20246|
|Contact: Kathrin Heitmann 40741059471 firstname.lastname@example.org|
|Contact: Ruken Özge Akbulak +4940741059471 email@example.com|
|Principal Investigator: Stephan Willems|
|Sub-Investigator: Rukeb Özge Akbulak|
|Sub-Investigator: Nele Geßler|
|Principal Investigator:||Stephan Willems, MD||Universitätsklinikum Hamburg-Eppendorf|