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NCT Number: NCT02019407

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrial Flutter Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PVI, CTI block

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.

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

PVI

Procedure

PVI (pulmonary isolation)

Primary outcomes

  1. Recurrence of Atrial fibrillation (AF free survival)

    Time frame: 3 month after catheter ablation

    clinical recurrence of AF after catheter ablation

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 24, 2013
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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