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

NCT03198858 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-04-30

No results posted yet for this study

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

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

PROCEDURE

CartoUnivu™

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

PROCEDURE

Ablation with Carto® 3 System

usual Pulmonary vein isolation Ablation with Carto® 3 System only

Sponsors & Collaborators

  • Biosense Webster, Inc.

    collaborator INDUSTRY

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Stephan Willems, MD · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-03-31
Completion
2019-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03198858 on ClinicalTrials.gov