Back to resultsProspective Randomized Study on Clinical Effectiveness of Carvo-Tricuspid Isthmus Block in Patients With Paroxysmal Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PVI, CTI block
PVI
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, atrial flutter, catheter ablation, cavo-tricuspid isthmus block
Eligibility Criteria
Inclusion Criteria:
- patients with documented AF
- Drug refractory AF
- Non-valvular AF
- No structural cardiac disease
- No intracardiac thrombi in cardiac CT and TEE
Exclusion Criteria:
- permanent AF refractory to electrical cardioversion
- LA size >55 mm as measured by echocardiography
- AF with valvular disease
- associated structural heart disease other than left ventricular hypertrophy
- prior AF ablation.
Sites / Locations
- ivision of Cardiology, Yonsei University Health System, Yonsei University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CTI group
Non CTI group
Arm Description
CTI(Cavo-Tricuspid Isthmus)
Non CTI (Cavo-Tricuspid Isthmus)
Outcomes
Primary Outcome Measures
Recurrence of Atrial fibrillation (AF free survival)
clinical recurrence of AF after catheter ablation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02019407
Brief Title
Prospective Randomized Study on Clinical Effectiveness of Carvo-Tricuspid Isthmus Block in Patients With Paroxysmal Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
April 26, 2018 (Actual)
Study Completion Date
April 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective Randomized Study on Clinical Effectiveness of Carvo-Tricuspid Isthmus (CTI) Block in Patients with Paroxysmal Atrial Fibrillation (PAF) will be performed. Study will be composed with two arms including 4 pulmonary vein isolation and pulmonary vein isolation with CTI block. After that all patients will be followed up by HRS(Heart Rhythm Society) 2010 expert consensus guideline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, atrial flutter, catheter ablation, cavo-tricuspid isthmus block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CTI group
Arm Type
Experimental
Arm Description
CTI(Cavo-Tricuspid Isthmus)
Arm Title
Non CTI group
Arm Type
Placebo Comparator
Arm Description
Non CTI (Cavo-Tricuspid Isthmus)
Intervention Type
Procedure
Intervention Name(s)
PVI, CTI block
Other Intervention Name(s)
radiofrequency catheter ablation (RFCA), Catheter ablation of cavo-tricuspid isthmus line for treatment of atrial flutter
Intervention Description
PVI (pulmonary isolation)
Catheter ablation of cavo-tricuspid isthmus line for treatment of atrial fibrillation
Catheter is inserted into inferior venacava (IVC) and right atrium (RA) via femoral vein. And the procedure is to block bidirectionally between inferior venacava (IVC) and the annulus of tricuspid valve (TV) by using electrical energy of catheter tip.
Intervention Type
Procedure
Intervention Name(s)
PVI
Intervention Description
PVI (pulmonary isolation)
Primary Outcome Measure Information:
Title
Recurrence of Atrial fibrillation (AF free survival)
Description
clinical recurrence of AF after catheter ablation
Time Frame
3 month after catheter ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with documented AF
Drug refractory AF
Non-valvular AF
No structural cardiac disease
No intracardiac thrombi in cardiac CT and TEE
Exclusion Criteria:
permanent AF refractory to electrical cardioversion
LA size >55 mm as measured by echocardiography
AF with valvular disease
associated structural heart disease other than left ventricular hypertrophy
prior AF ablation.
Facility Information:
Facility Name
ivision of Cardiology, Yonsei University Health System, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
23572499
Citation
Mohanty S, Mohanty P, Di Biase L, Bai R, Santangeli P, Casella M, Dello Russo A, Tondo C, Themistoclakis S, Raviele A, Rossillo A, Corrado A, Pelargonio G, Forleo G, Natale A. Results from a single-blind, randomized study comparing the impact of different ablation approaches on long-term procedure outcome in coexistent atrial fibrillation and flutter (APPROVAL). Circulation. 2013 May 7;127(18):1853-60. doi: 10.1161/CIRCULATIONAHA.113.001855. Epub 2013 Apr 9.
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Prospective Randomized Study on Clinical Effectiveness of Carvo-Tricuspid Isthmus Block in Patients With Paroxysmal Atrial Fibrillation
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