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

NCT ID: NCT02019407

Last Updated: 2019-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-04-26

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CTI group

CTI(Cavo-Tricuspid Isthmus)

Group Type EXPERIMENTAL

PVI, CTI block

Intervention Type PROCEDURE

* 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.

Non CTI group

Non CTI (Cavo-Tricuspid Isthmus)

Group Type PLACEBO_COMPARATOR

PVI

Intervention Type PROCEDURE

PVI (pulmonary isolation)

Interventions

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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.

Intervention Type PROCEDURE

PVI

PVI (pulmonary isolation)

Intervention Type PROCEDURE

Other Intervention Names

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radiofrequency catheter ablation (RFCA), Catheter ablation of cavo-tricuspid isthmus line for treatment of atrial flutter

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ivision of Cardiology, Yonsei University Health System, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 23572499 (View on PubMed)

Other Identifiers

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4-2013-0639

Identifier Type: -

Identifier Source: org_study_id

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