Surgical Ablation for Atrial Fibrillation

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Thoracoscopic Atrial fibrillation Ablation

Procedure

After blunt dissection of the oblique and transverse sinus, an AtriCure Lumitip Dissector was introduced around the pulmonary veins. Pulmonary vein isolation was achieved with an AtriCure Isolator Synergy ablation clamp around the pulmonary vein antrum at least six times for each side. Ganglionated plexus identification and ablation were performed using an AtriCure Synergy ablation pen. The additional superior and inferior ablation lines connecting the bilateral pulmonary vein isolations were created by applying the AtriCure Synergy ablation pen. Following completion of the ablation on the right side, ablation on the left side was accomplished in a similar manner. The ligament of Marshall was dissected by electrical cautery. Conduction block was confirmed upon completion of the ablation procedure on the left side.

Primary outcomes

efficacy - sinus rhythm

Time frame: 1 year

Number of patients with sinus rhythm, without detections of atrial arrhythmias (episodes longer than 30 seconds)

Secondary outcomes

periprocedural complications - surgery

Time frame: 30 days after surgery

conversion to sternotomy, bleeding, thromboembolic events, tamponade, haemothorax, pneumothorax, pleural effusion, pneumonia

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

Minimally Invasive Surgical Ablation for Standalone Atrial Fibrillation

Important dates

Study start: 2012
Primary completion: 2019
Study completion: 2020
First posted: May 22, 2020
Registry last updated: May 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed