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Real-Time Assessment of Cryoballoon Pulmonary Vein Isolation Using a Novel Circular Mapping Catheter

NCT01448265 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-07-25

No results posted yet for this study

Summary

Background: Atrial fibrillation (AF) is the most frequent sustained cardiac arrhythmia, impairs quality of life and increases stroke risk and mortality. Recent clinical experience with the Arctic Front™ cryoballoon ablation catheter system (Medtronic) suggests that it can be used to isolate the pulmonary veins (PVs) safely and effectively in patients with AF, thereby eliminating the recurrence of AF.

Hypothesis: Our hypotheses are (1) that visualization of real-time pulmonary vein conduction during cryoballoon ablation of atrial fibrillation using a novel spiral circumferential mapping catheter (Achieve™) is feasible and safe, and (2) that procedure and fluoroscopy times decrease with experience.

Objective: The purpose of this study is to assess safety, feasibility, and a learning curve associated with cryoballoon catheter ablation using a novel circular mapping catheter (Achieve™, Medtronic) inserted through the lumen of the cryoballoon in patients with symptomatic paroxysmal atrial fibrillation.

The primary goal is to evaluate successful pulmonary vein isolation using the Achieve™ mapping catheter. The reduction of procedure and fluoroscopy times during the first 40 patients treated with this approach will be analyzed to evaluate a potential learning curve upon introduction of the technique.

Conditions

Interventions

PROCEDURE

Cryoballoon ablation.

Cryoballoon ablation using a novel circular mapping catheter.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Dierk Thomas, MD · Department of Cardiology, University of Heidelberg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

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 NCT01448265 on ClinicalTrials.gov