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

Yonsei University

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: PVI; Procedure: PVI, CTI block

Study type: Interventional

Funder types: Other

Identifiers

NCT02019407

4-2013-0639

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups, including a placebo group

CTI group

Experimental group

Description:

CTI(Cavo-Tricuspid Isthmus)

Treatment:

Procedure: PVI, CTI block

Non CTI group

Placebo Comparator group

Description:

Non CTI (Cavo-Tricuspid Isthmus)

Treatment:

Procedure: PVI