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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02984371
Other study ID # ASTR_0789
Secondary ID
Status Recruiting
Phase Phase 2
First received December 2, 2016
Last updated December 2, 2016
Start date June 2016
Est. completion date February 2018

Study information

Verified date December 2016
Source Meshalkin Research Institute of Pathology of Circulation
Contact Alexander Romanov, MD, PhD
Phone +73833327655
Email abromanov@mail.ru
Is FDA regulated No
Health authority Russia: Ethics Committee
Study type Interventional

Clinical Trial Summary

The aim of this prospective randomized study was to assess the efficacy of ablation of the ganglionated plexi localized in the epicardial fat pads for preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass grafting.


Recruitment information / eligibility

Status Recruiting
Enrollment 264
Est. completion date February 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- History of paroxysmal atrial fibrillation (recurrent episodes for at least 1 years, with 2 documented episodes over the last 6 months)

- Indication for cardiac surgery (e.g. coronary artery bypass grafting, valve repair/replacement) according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for cardiac surgery

Exclusion Criteria:

Previous heart surgery or atrial fibrillation ablation procedure Emergency coronary artery bypass grafting Unstable angina or heart failure Persistent atrial fibrillation Planned maze procedure or pulmonary vein isolation Unwillingness to participate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Procedure:
Coronary artery bypass grafting

Epicardial ganglionated plexi ablation

implantable loop recorder


Locations

Country Name City State
Russian Federation State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation Novosibirsk
Russian Federation Cardiology Research Institute Tomsk

Sponsors (1)

Lead Sponsor Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence of any atrial tachyarrhythmia, including atrial fibrillation and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug 12 month Yes
Secondary atrial fibrillation burden 12 month Yes
Secondary incidence of congestive heart failure 12 month Yes
Secondary incidence of sustained ventricular arrhythmias 12 month Yes
Secondary rehospitalization 12 month Yes
Secondary stroke or transient ischemic attack 12 month Yes
Secondary number of Deaths 12 month Yes
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