Primary Anatomical Versus Primary Electrophysiological Approach in Circumferential Pulmonary Vein Ablation (CPVA-PAF)

November 9, 2007 updated by: University Hospital, Bonn

Circumferential Pulmonary Vein Ablation in Paroxysmal Atrial Fibrillation: Randomized Comparison Between a Primary Anatomical Versus a Primary Electrophysiological Approach

Randomized comparison between 2 techniques of circumferential pulmonary vein ablation in paroxysmal atrial fibrillation: Primary anatomical ablation with secondary closure of possible electrical gaps versus primary electrophysiological ablation at the sites of atrio-venous electrical breakthroughs with secondary circumferential ablation around the pulmonary vein orifice

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • paroxysmal atrial fibrillation
  • age over 18 years

Exclusion Criteria:

  • persistent atrial fibrillation
  • reversible cause of atrial fibrillation
  • inability to comply with follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
primary electrophysiological approach
Procedure: primary electrophysiological approach
primary ablation of atrio-venous breakthrough sites followed by circumferential ablation around pulmonary vein orifice
Active Comparator: 2
primary anatomical approach
Procedure: primary anatomical approach
primary circumferential ablation around the pulmonary vein orifice followed by ablation of possible conduction gaps

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom from atrial tachyarrhythmias at 6-months follow-up
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of procedural characteristics (duration, fluoroscopy time, ablation time, ablation energy, complications)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Investigators

  • Principal Investigator: Lars M Lickfett, MD, University Hospital Bonn, Department of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

November 9, 2007

First Submitted That Met QC Criteria

November 9, 2007

First Posted (Estimate)

November 12, 2007

Study Record Updates

Last Update Posted (Estimate)

November 12, 2007

Last Update Submitted That Met QC Criteria

November 9, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPVA-PAF
  • IRB 160/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Paroxysmal Atrial Fibrillation

Clinical Trials on primary electrophysiological approach

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe