Hybrid Catheter Ablation for Persistent Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT02979847|
Recruitment Status : Unknown
Verified November 2016 by Young-Hoon Kim, Korea University Anam Hospital.
Recruitment status was: Recruiting
First Posted : December 2, 2016
Last Update Posted : December 2, 2016
prospective randomized controlled trial
In repeat procedure for persistent atrial fibrillation, Hybrid group (Epicardial ablation + Endocardial ablation) versus control group (conventional Endocardial ablation)
Freedom from AF/Atrial tachycardia and safety
|Condition or disease||Intervention/treatment||Phase|
|Persistent Atrial Fibrillation||Procedure: hybrid catheter ablation Procedure: conventional endocardial ablation||Not Applicable|
Epicardial (EPI) catheter approach is considered as an accessory to endocardial (ENDO) ablation for persistent atrial fibrillation (PeAF). We evaluated the effectiveness and safety of EPI ablation as first option to the patients who had previous endocardial ablation for PeAF.
This is prospective randomized controlled, single center study. study population is recurred AF patient with failed previous ENDO catheter ablation for PeAF. The investigators randomized study population to both groups: Hybrid group (EpI + ENDO ablation) versus control group (conventional ENDO ablation). Clinical outcome (Freedom from AF/Atrial tachycardia) and procedural safety will be compared.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Epicardial Catheter Ablation in Repeated Procedure for Persistent Atrial Fibrillation: Prospective Randomized Controlled Trial|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2018|
hybrid catheter ablation (both epicardial and endocardial mapping and ablation)
Procedure: hybrid catheter ablation
trans-xyphoid epicardial puncture is performed and 20-pole catheter via SL-1 sheath is inserted. Voltage mapping or activation mapping or CFAE mapping is performed as rhythm status. Epicardial and Endocardial side ablation were performed.
Active Comparator: Control
conventional mapping and ablation in endocardial side
Procedure: conventional endocardial ablation
trans-femoral puncture is performed. Voltage mapping or activation mapping or CFAE mapping is performed as rhythm status. Endocardial side ablation were performed and Epicardial side is not assessed.
- Freedom from AF/AT recurrence [ Time Frame: 12 months ]Freedom from sustained AF/AT recurrence without using anti-arrhythmic drug Sustained AF/AT: sustained more than 30 sec documentation in clinical electrocardiography, Holter, event recorder
- Number of participants with treatment-related adverse events [ Time Frame: 12 months ]Procedure related complication requiring surgical manage, transfusion, medical treatment
- Predictor for recurrence of AF/AT [ Time Frame: 12 months ]To evaluate predictor for recurrence of atrial tachyarrhythmia after repeated catheter ablation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02979847
|Contact: Seung-Young Roh, MDemail@example.com|
|Contact: Kwang No Lee, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Korea University Medical Center Anam hospital||Recruiting|
|Seoul, Korea, Republic of, 02841|
|Contact: Young-Hoon Kim, President +82-2-920-5445 email@example.com|
|Principal Investigator:||Young-Hoon Kim, MD, PhD||Korea University|