Surgical Ablation for Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Minimally Invasive Surgical Ablation for Standalone Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04398979
• Other study ID #: JPSH-AF2012
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: February 1, 2020

Study information

• Verified date: May 2020
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 1, 2020
• Est. primary completion date: December 31, 2019
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Thoracoscopic Atrial fibrillation Ablation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

References & Publications (1)

Tanaka K, Koga M, Lee KJ, Kim BJ, Park EL, Lee J, Mizoguchi T, Yoshimura S, Cha JK, Lee BC, Nakahara J, Suzuki N, Bae HJ, Toyoda K; CRCS-K Investigators and the SAMURAI Study Investigators. Atrial Fibrillation-Associated Ischemic Stroke Patients With Prior Anticoagulation Have Higher Risk for Recurrent Stroke. Stroke. 2020 Apr;51(4):1150-1157. doi: 10.1161/STROKEAHA.119.027275. Epub 2020 Feb 26. Erratum in: Stroke. 2020 May;51(5):e99. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy - sinus rhythm	Number of patients with sinus rhythm, without detections of atrial arrhythmias (episodes longer than 30 seconds)	1 year
Secondary	periprocedural complications - surgery	conversion to sternotomy, bleeding, thromboembolic events, tamponade, haemothorax, pneumothorax, pleural effusion, pneumonia	30 days after surgery