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NCT02019407 Clinical Trial

Prospective Randomized Study on Clinical Effectiveness of Carvo-Tricuspid Isthmus Block in Patients With Paroxysmal Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02019407
Other study ID # 4-2013-0639
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date April 26, 2018

Study information
Verified date December 2018
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 128
Est. completion date April 26, 2018
Est. primary completion date April 26, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• PVI, CTI block
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.
• PVI
PVI (pulmonary isolation)

Locations
Country Name City State
Korea, Republic of ivision of Cardiology, Yonsei University Health System, Yonsei University College of Medicine Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence of Atrial fibrillation (AF free survival) clinical recurrence of AF after catheter ablation 3 month after catheter ablation
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