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
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
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
NCT ID
NCT03332862
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
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
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Continuous Versus Discontinuous Design of Encircling Lesions During Ablation for Atrial Fibrillation
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