Prospective Randomized Study on Clinical Effectiveness of Carvo-Tricuspid Isthmus Block in Patients With Paroxysmal Atrial Fibrillation
1 other identifier
interventional
128
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Jan 2015
Typical duration for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2013
CompletedFirst Posted
Study publicly available on registry
December 24, 2013
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2018
CompletedMarch 27, 2019
December 1, 2018
3.3 years
December 6, 2013
March 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence of Atrial fibrillation (AF free survival)
clinical recurrence of AF after catheter ablation
3 month after catheter ablation
Study Arms (2)
CTI group
EXPERIMENTALCTI(Cavo-Tricuspid Isthmus)
Non CTI group
PLACEBO COMPARATORNon CTI (Cavo-Tricuspid Isthmus)
Interventions
* 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.
Eligibility Criteria
You may qualify if:
- patients with documented AF
- Drug refractory AF
- Non-valvular AF
- No structural cardiac disease
- No intracardiac thrombi in cardiac CT and TEE
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ivision of Cardiology, Yonsei University Health System, Yonsei University College of Medicine
Seoul, 120-752, South Korea
Related Publications (1)
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.
PMID: 23572499BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2013
First Posted
December 24, 2013
Study Start
January 1, 2015
Primary Completion
April 26, 2018
Study Completion
April 26, 2018
Last Updated
March 27, 2019
Record last verified: 2018-12