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

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

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Procedure: Ablation with Carto® 3 System; Procedure: CartoUnivu™

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany
    • Herzzentrum der Universität zu Köln
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Ablation with Carto® 3 System	Procedure: Ablation with Carto® 3 System; usual Pulmonary vein isolation Ablation with Carto® 3 System only
Other: Ablation CartoUnivu™	Procedure: CartoUnivu™; Ablation with Carto® 3 System and image integration module = IIM, CartoUnivu™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation duration	Reduction of radiation duration during ablation	1 year follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
procedure duration	Reduction of procedure duration during ablation	1 year follow up

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Biosense Webster, Inc.
• Investigators: Principal Investigator: Stephan Willems, MD, Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: April 18, 2016
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (Actual): June 26, 2017

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 28, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Paroxysmal Atrial Fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: PV4975

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No