Thoracoscopic Ablation for Lone Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Two Strategies in Thoracoscopic Ablation for Lone Atrial Fibrillation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05708027
• Other study ID #: TA-AF
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 6, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: January 2023
• Source: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients of the thoracoscopic group were divided into 3 subgroups: I - low (no HF), II - medium (possible) and III - high risk of HF (HF confirmed) (Table 1). A statistically significant difference was found for the indicator: age (in the "high probability" group in relation to the "low probability" group by an average of 5.5 years; p=0.002) (Table 1). The clinical characteristics of patients in the studied subgroups are presented in Table 2, no significant difference was found for any of the compared indicators. The nature of the cardiac arrhythmia and the severity of clinical symptoms are presented in Table 3. Significant differences were obtained for the following indicators: CHADS2VASc (in group III, "high probability" in relation to group I, "low probability" by an average of 1 point; p=0.008); HFA-PEFF (in group III, "high probability" by relative to group I "low probability" by an average of 5 points; p<0.001). Also, significant dynamics was obtained by the frequency of diagnosis of paroxysmal and long-lasting persistent forms of AF (p=0.025). Significant differences were obtained in the number of patients with 3 FC of heart failure (in group III, compared with group I, 5.3% vs 0.0%, respectively)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 232
• Est. completion date: September 30, 2023
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Diseases

Intervention

Procedure:
• Thoracoscopic surgical ablation
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.

Locations

Country	Name	City	State
Russian Federation	Federal Research Clinical Center of Federal Medical & Biological Agency	Moscow
Russian Federation	Federal State Budget Institution Clinical hospital	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia	Federal State Budget Institution Clinical Hospital, Moscow, Russia

Country where clinical trial is conducted

Russian Federation, 

References & 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Heart rhythm	Heart rhythm (sinus rhythm, atrial fibrillation, pacemaker rhythm)	at the time of discharge
Secondary	Recurrence of atrial fibrillation	Development of recurrence of atrial fibrillation after thoracoscopic ablation	period after 3 month - 5 year.
Secondary	Cardiac Remodeling	Assessment cardiac remodeling after thoracoscopic ablation (indexed left atrial volume, ejection fraction, systolic pulmonary artery pressure)	after discharge - 5 year
Secondary	Functional class of heart failure	Assessment of the functional class of heart failure after thoracoscopic ablation	1-5 year.
Secondary	Stroke and Transitory ischemic attack	Development of Stroke and Transitory ischemic attack after thoracoscopic ablation	after discharge - 5 year
Secondary	Unplanned cardiovascular hospitalization	Unplanned non-cardiovascular hospitalization after thoracoscopic ablation	after discharge - 5 year