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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02019407
Enrollment
128
Registered
2013-12-24
Start date
2015-01-31
Completion date
2018-04-26
Last updated
2019-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, atrial flutter, catheter ablation, cavo-tricuspid isthmus block

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.

Interventions

PROCEDUREPVI, 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.

PROCEDUREPVI

PVI (pulmonary isolation)

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Recurrence of Atrial fibrillation (AF free survival)3 month after catheter ablationclinical recurrence of AF after catheter ablation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026