Thoracoscopic Ablation for Lone Atrial Fibrillation

NCT05708027 | Unknown Phase 3

• 1 other identifier: TA-AF
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Thoracoscopic ablation is an effective treatment of patients with atrial fibrillation. Nowadays, 2 types of ablative devices are available in clinical practice allowing one to perform the thoracoscopic procedure - Medtronic and AtriCure. However, the contemporary clinical literature does not have enough data that would compare these two approaches. Aims: to perform a comparative analysis of the short-term results of two minimally invasive strategies in thoracoscopic ablation for atrial fibrillation. Methods: The retrospective study was performed in which included 232 patients underwent thoracoscopic ablation for atrial fibrillation in two clinical centers for the period from 2016 to August 2021. The patients were divided into 2 groups. The first group was represented by those patients to whom a Medtronic device was applied (n=140), the second group was treated with an AtriCure device (n=92). The patients were comparable in their age, gender, initial severity of the condition. The follow-up consisted of laboratory tests, chest Х-ray, electrocardiography, 24-hour Holter monitor, echocardiography. The structure and prevalence of intraoperative and postoperative complications, specifics of the postoperative period were compared between the two groups.

Conditions

Atrial Fibrillation; Heart Diseases

Keywords

Thoracoscopic ablation; Atrial Fibrillation; Ablation technique

Outcome Measures

Primary Outcomes (3)

• The number of intraoperative complications

  The number of intraoperative complications (Mortality, Stroke, Transient ischaemic attack, Sternotomy for bleeding, Mini-sternotomy for bleeding, Mini-thoracotomy for bleeding, Bleeding with discontinuation of procedure)

  Day 1

• Postoperative complications

  Postoperative complications: Major complications (Death, Reinterventions, Re-intubation without haemodynamic instability, Re-intubation due to haemodynamic instability, Venous lung infarction, Lung emboli, Permanent phrenic nerve paralysis, Stroke, Transient ischaemic attack, Atrium-oesophagus fistula, Myocardial infarction, Renal failure necessitating dialysis, Sepsis) and Minor complications (Pericardial fluid necessitating pericardiocentesis, Permanent pacemaker implantation, Thoracostomy drain, Infections, Delirium, Gastrointestinal bleeding)

  1 mounth

• Heart rhythm

  Heart rhythm (sinus rhythm, atrial fibrillation, pacemaker rhythm)

  at the time of discharge

Secondary Outcomes (5)

• Recurrence of atrial fibrillation

  period after 3 month - 5 year.

• Cardiac Remodeling

  after discharge - 5 year

• Functional class of heart failure

  1-5 year.

• Stroke and Transitory ischemic attack

  after discharge - 5 year

• Unplanned cardiovascular hospitalization

  after discharge - 5 year

Study Arms (2)

AtriCure

EXPERIMENTAL

Group of patients to whom was applied AtriCure device during thoracoscopic ablation.

Procedure: Thoracoscopic surgical ablation

Medtronic

ACTIVE COMPARATOR

Group of patients to whom was applied Medtronic device during thoracoscopic ablation.

Procedure: Thoracoscopic surgical ablation

Interventions

Thoracoscopic surgical ablation PROCEDURE

Thoracoscopic surgical ablation is a minimally invasive procedure used to treat atrial fibrillation by creation Box Lesion Set using Radio Frequency Energy. Pulmonary veins isolation was performed using ablation clamps, whereas isolation of the posterior left atrium (box) was performed using a clamping Medtronic or a linear nonclamping AtriCure device.

AtriCure; Medtronic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• persistent or long-lasting persistent form of atrial fibrillation;
• age over 18 years;
• failure of conservative therapy with the use of Class I and III antiarrhythmic drugs (Vaughan Williams classification);
• absence of marked structural pathology of the heart, requiring surgical treatment.

You may not qualify if:

• secondary atrial fibrillation due to reversible cause (pericarditis, hyperthyroidism, TELA, pneumonia, hypokalemia, etc.);
• surgical interventions on thoracic or mediastinal organs;
• age less than 18 years;
• presence of indications for open heart surgery under conditions of artificial circulation;
• heart failure with ejection fraction less than 30%;
• acute cerebral circulation disorder less than 3 months old;
• acute myocardial infarction or coronary stenting less than 3 months old;
• active systemic infection;
• left atrial appendage thrombosis detected one day before surgery;
• hemodynamically significant atherosclerotic lesion of coronary arteries and myocardial ischemia at the time of indications for surgery (confirmed by functional tests and coronarography);
• presence of contraindications for direct and indirect anticoagulants;
• presence of concomitant diseases of other organs and systems, which can lead to death within the first 2 years after the operation.

Sponsors & Collaborators

• Federal Research Clinical Center of Federal Medical & Biological Agency, Russia: lead
• Federal State Budget Institution Clinical Hospital, Moscow, Russia: collaborator

Study Sites (2)

Federal State Budget Institution Clinical hospital

Moscow, 107143, Russia

Location

Federal Research Clinical Center of Federal Medical & Biological Agency

Moscow, 115682, Russia

Location

Related Publications (1)

• Zotov AS, Troitsky AV, Silaev AA, Sakharov ER, Sukhotin VN, Shelest OO, Khabazov RI, Timashkov DA. Short-Term Results of Two Strategies in Thoracoscopic Ablation for Lone Atrial Fibrillation. Journal of Clinical Practice. 2022;13(3):5-16.doi: https://doi.org/10.17816/clinpract110719

  BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Heart Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Alexander V Troitskiy, MD, SD

  Federal Research and Clinical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: February 1, 2023
• Study Start: January 6, 2021
• Primary Completion: August 31, 2022
• Study Completion: September 30, 2023
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)