Surgical Ablation for Atrial Fibrillation

NCT ID: NCT04398979

Last Updated: 2020-05-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2020-02-01

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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hong Liu

Investigator of the First Hospital of Nanjing Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 32098607 (View on PubMed)

Other Identifiers

JPSH-AF2012

Identifier Type: -

Identifier Source: org_study_id