search
Back to results

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

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
catheter ablation
Sponsored by
Institute for Clinical and Experimental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Catheter Ablation, Atrial Fibrillation, Contact Force, Continuous Ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Institute for Clinical and Experimental MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Discontinuous ablation

Continuous ablation

Arm Description

perform discontinuous ablation of ipsilateral pulmunary veins.

perform continuous ablation of ipsilateral pulmunary veins.

Outcomes

Primary Outcome Measures

Combined unsuccessful PVI or PV reconnection
Combined unsuccessfuk PVI after completeing the primary lesion set or PV reconnection during the waiting time

Secondary Outcome Measures

Early pulmunary veins reconnection
Early pulmunary veins reconnection within the first 10 min after PVI

Full Information

First Posted
November 1, 2017
Last Updated
November 1, 2017
Sponsor
Institute for Clinical and Experimental Medicine
Collaborators
Charles University, Czech Republic, 3rd Department of Internal Medicine - Cardiology
search

1. Study Identification

Unique Protocol Identification Number
NCT03332862
Brief Title
Continuous Versus Discontinuous Design of Encircling Lesions During Ablation for Atrial Fibrillation
Acronym
CDAF
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
January 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute for Clinical and Experimental Medicine
Collaborators
Charles University, Czech Republic, 3rd Department of Internal Medicine - Cardiology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Catheter Ablation, Atrial Fibrillation, Contact Force, Continuous Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Discontinuous ablation
Arm Type
Experimental
Arm Description
perform discontinuous ablation of ipsilateral pulmunary veins.
Arm Title
Continuous ablation
Arm Type
Active Comparator
Arm Description
perform continuous ablation of ipsilateral pulmunary veins.
Intervention Type
Procedure
Intervention Name(s)
catheter ablation
Intervention Description
catheter ablation for atrial fibrillation treatment
Primary Outcome Measure Information:
Title
Combined unsuccessful PVI or PV reconnection
Description
Combined unsuccessfuk PVI after completeing the primary lesion set or PV reconnection during the waiting time
Time Frame
30 min after ablation
Secondary Outcome Measure Information:
Title
Early pulmunary veins reconnection
Description
Early pulmunary veins reconnection within the first 10 min after PVI
Time Frame
10 min.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing pulmonary vein isolation with radiofrequency catheter ablation for paroxysmal atrial fibrillation treatment. Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bashar Aldhoon, MD, PhD
Phone
+420739528025
Email
baaĺ@ikem.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bashar Aldhoon, MD, PhD
Organizational Affiliation
Institute for Clinical and Experimental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Clinical and Experimental Medicine
City
Praha
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bashar Aldhoon, MD,PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
34988847
Citation
Aldhoon B, Peichl P, Osmancik P, Konecny P, Kautzner J, Wichterle D. Acute efficacy of contiguous versus temporally discontiguous point-by-point radiofrequency pulmonary vein isolation in patients with paroxysmal atrial fibrillation: a randomized study. J Interv Card Electrophysiol. 2022 Sep;64(3):661-667. doi: 10.1007/s10840-021-01113-9. Epub 2022 Jan 6.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs