Surgical Ablation for Atrial Fibrillation

NCT04398979 | Completed DMC

• 1 other identifier: JPSH-AF2012
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• efficacy - sinus rhythm

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

  1 year

Secondary Outcomes (1)

• periprocedural complications - surgery

  30 days after surgery

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with symptomatic, drug-resistant, stand-alone, paroxysmal, persistent or long-standing persistent atrial fibrillation

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nanjing Medical University: lead

Related 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.

  PMID: 32098607 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator of the First Hospital of Nanjing Medical University

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: January 1, 2012
• Primary Completion: December 31, 2019
• Study Completion: February 1, 2020
• Last Updated: May 22, 2020

Record last verified: 2020-05