Surgical Ablation for Atrial Fibrillation

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT04398979
• Lead Sponsor: Nanjing Medical University

Brief Summary

Minimally invasive approaches for surgical treatment have been advocated as a treatment option for stand-alone atrial fibrillation (AF). This study will investigate the clinical outcomes after minimally invasive surgical ablation of both paroxysmal and persistent/longstanding persistent AF.

Detailed Description

Atrial fibrillation (AF) patients with a previous stroke are often at a high risk of recurrent stroke and bleeding. Minimally invasive approaches for surgical treatment have been advocated as a treatment option for stand-alone AF. This study will investigate the clinical outcomes after minimally invasive surgical ablation of both paroxysmal and persistent/longstanding persistent AF. Neurological safety will be assessed by cerebral magnetic resonance, neuropsychological examination and periprocedural transcranial Doppler measurement.

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-02-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-19
• Study First Submitted QC: 2020-05-19
• Last Update Submitted: 2020-05-19
• Study First Posted: 2020-05-22
• Last Update Posted: 2020-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients age > 18 years
• Patients with paroxysmal, or persistent/long-standing persistent AF according to the standard EHRA definition.
• Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication.
• Absence of significant structural heart disease (dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular heart disease, untreated coronary artery disease)

Exclusion Criteria

• AF secondary to a reversible cause (i.e., thyreopathy, etc.) Indication for open-heart surgery (coronary artery bypass grafting, valve surgery, etc.)
• Severe left ventricle dysfunction that is clearly caused by some other cardiac disease (dilated cardiomyopathy, ischaemic heart disease, etc.) where the AF is clearly of secondary etiology
• Known severe pericardial and pleural adhesions (e.g., history of cardiac surgery)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy - sinus rhythm	1 year	Number of patients with sinus rhythm, without detections of atrial arrhythmias (episodes longer than 30 seconds)

Secondary Outcome Measures

Name	Time	Method
periprocedural complications - surgery	30 days after surgery	conversion to sternotomy, bleeding, thromboembolic events, tamponade, haemothorax, pneumothorax, pleural effusion, pneumonia