Continuous Versus Discontinuous Design of Encircling Lesions During Ablation for Atrial Fibrillation (CDAF)

November 1, 2017 updated by: Bashar Aldhoon, Institute for Clinical and Experimental Medicine

Acute Efficacy of Point-by-point Radiofrequency Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation: a Randomized Comparison of Continuous Versus Discontinuous Design of Encircling Lesions

Acute efficacy of point-by-point radiofrequency ablation for pulmonary vein isolation in patients with atrial fibrillation are comparable independantly of the ablation strategy (continous versus discontinuous ablation) under the same condition of power delivery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The number of pulmonary vein isolation (PVI) therapy for atrial fibrillation (AF) is increasing. Durable PVI is cornerstone for long-term freedom of AF. In one previous study continuous ablation was suggested to be more efficient in durable PVI. However, this hypothesis has not been proven in randomized fashion.

The current study is to confirm whether continuous versus discontinuous design of encircling lesions are comparable under the same conditions of power delivery.

The study design is a two-centre prospective randomized trial to compare the acute efficacy by using the above described approaches.

Study Type

Interventional

Enrollment (Anticipated)

30

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.

Study Contact

  • Name: Bashar Aldhoon, MD, PhD
  • Phone Number: +420739528025
  • Email: baaĺ@ikem.cz

Study Locations

  • Czechia
      • Praha, Czechia
        • Recruiting
        • Institute for Clinical and Experimental Medicine
        • Contact:
          • Bashar Aldhoon, MD,PhD

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing pulmonary vein isolation with radiofrequency catheter ablation for paroxysmal atrial fibrillation treatment.

Exclusion Criteria:

-

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: Discontinuous ablation
perform discontinuous ablation of ipsilateral pulmunary veins.
Procedure: catheter ablation
catheter ablation for atrial fibrillation treatment
Active Comparator: Continuous ablation
perform continuous ablation of ipsilateral pulmunary veins.
Procedure: catheter ablation
catheter ablation for atrial fibrillation treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined unsuccessful PVI or PV reconnection
Time Frame: 30 min after ablation
Combined unsuccessfuk PVI after completeing the primary lesion set or PV reconnection during the waiting time
30 min after ablation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early pulmunary veins reconnection
Time Frame: 10 min.
Early pulmunary veins reconnection within the first 10 min after PVI
10 min.

Collaborators and Investigators

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

Sponsor

Institute for Clinical and Experimental Medicine

Collaborators

Charles University, Czech Republic
3rd Department of Internal Medicine - Cardiology

Investigators

  • Principal Investigator: Bashar Aldhoon, MD, PhD, Institute for Clinical and Experimental Medicine

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 (Actual)

September 15, 2017

Primary Completion (Anticipated)

December 31, 2017

Study Completion (Anticipated)

January 31, 2018

Study Registration Dates

First Submitted

November 1, 2017

First Submitted That Met QC Criteria

November 1, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G-17-06-22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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