Surgical Ablation of Long-standing Persistent AF During CABG

Surgical Ablation of Long-standing Persistent Atrial Fibrillation During CABG Through Continuous Subcutaneous Monitoring

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02246790

Acronym

LABARFA

Enrollment

116

Registered

2014-09-23

Start date

2014-12-31

Completion date

2017-12-31

Last updated

2015-11-13

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

Conditions

Coronary Artery Disease

Keywords

ablation, CABG, Long-standing persistent Atrial Fibrillation

Brief summary

Purpose. Comparison of outcomes in patients underwent CABG combined with left atrial and biatrial radiofrequency ablation of long-standing persistent atrial fibrillation. Hypothesis of the study - patients with long-standing persistent atrial fibrillation and coronary artery disease after CABG in combination with biatrial RFA have a better outcomes for the freedom of AF compared with patients undergoing left atrial RFA during CABG.

Detailed description

This is a single blinded prospective randomized study involving 116 patients with long-standing persistent AF and coronary artery disease. 116 patients are required to have a 80% chance of detecting, as significant at the 5% level, an increase in the primary outcome (freedom fro AF) measure by 12% in the biatrial group over left atrial group. Patients are divided into two groups, group I - biatrial + CABG (58 patients), and group II - left atrial + CABG (58 patients). Randomization is conducted by using accidental sampling before operation. The blinding process is applied to a patient, who is informed about received coronary artery bypass grafting, but don't know about kind of surgical ablation. Subcutaneous cardiac monitor is implanted to all patients for cardiac rhythm monitoring.

Interventions

PROCEDUREBiatrial radiofrequency ablation and CABG

Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant biatrial RFA during CPB.

PROCEDURELeft atrial radiofrequency ablation and CABG

Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant left atrial RFA during CPB.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* American College of Cardiology (ACC)/ American Heart Association (AHA) Indications for CABG * At least 2 ECG-verified (12-channel ECG, Holter telemetry) long-term persistent AF within last 12 months * The patient's consent to participate in the study

Exclusion criteria

* Intolerance of antiarrhythmic drugs * Heart valve disease requiring invasive treatment * Left atria more than 6.5 cm * Prior cardiac surgery * Active pacemaker treatment * Active anti-arrhythmic treatment (AAD) class I and III * Contraindication to oral anticoagulant/heparin treatment * Ejection fraction less than 30 % (EF \< 30 %) assessed by transthoracic echocardiography

Design outcomes

Primary

Measure	Time frame	Description
Freedom from atrial fibrillation	up to 36 months	Freedom from AF. All cases of AF after surgical intervention. Atrial fibrillation is defined as atrial fibrillation paroxysm lasting at least 60 seconds. Patients with AF\>0.5% were classified as non-responders.

Secondary

Measure	Time frame	Description
Cardiovascular events	Within three years after surgery	All cases of stroke, cardiac infarction, thromboembolism, bleeding and death

Countries

Russia

Contacts

Primary ContactSardor Rakhmonov

sardor5507@mail.ru+79231278557

Outcome results

None listed

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