Back to resultsThoracoscopic Ablation for Lone Atrial Fibrillation
Primary Purpose
Atrial Fibrillation, Heart Diseases
Status
Active
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Thoracoscopic surgical ablation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Thoracoscopic ablation, Atrial Fibrillation, Ablation technique
Eligibility Criteria
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.
Sites / Locations
- Federal State Budget Institution Clinical hospital
- Federal Research Clinical Center of Federal Medical & Biological Agency
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AtriCure
Medtronic
Arm Description
Group of patients to whom was applied AtriCure device during thoracoscopic ablation.
Group of patients to whom was applied Medtronic device during thoracoscopic ablation.
Outcomes
Primary Outcome Measures
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)
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)
Heart rhythm
Heart rhythm (sinus rhythm, atrial fibrillation, pacemaker rhythm)
Secondary Outcome Measures
Recurrence of atrial fibrillation
Development of recurrence of atrial fibrillation after thoracoscopic ablation
Cardiac Remodeling
Assessment cardiac remodeling after thoracoscopic ablation (indexed left atrial volume, ejection fraction, systolic pulmonary artery pressure)
Functional class of heart failure
Assessment of the functional class of heart failure after thoracoscopic ablation
Stroke and Transitory ischemic attack
Development of Stroke and Transitory ischemic attack after thoracoscopic ablation
Unplanned cardiovascular hospitalization
Unplanned non-cardiovascular hospitalization after thoracoscopic ablation
Full Information
NCT ID
NCT05708027
First Posted
October 26, 2022
Last Updated
January 24, 2023
Sponsor
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Collaborators
Federal State Budget Institution Clinical Hospital, Moscow, Russia
1. Study Identification
Unique Protocol Identification Number
NCT05708027
Brief Title
Thoracoscopic Ablation for Lone Atrial Fibrillation
Official Title
Two Strategies in Thoracoscopic Ablation for Lone Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 6, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Collaborators
Federal State Budget Institution Clinical Hospital, Moscow, Russia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Heart Diseases
Keywords
Thoracoscopic ablation, Atrial Fibrillation, Ablation technique
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
232 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AtriCure
Arm Type
Experimental
Arm Description
Group of patients to whom was applied AtriCure device during thoracoscopic ablation.
Arm Title
Medtronic
Arm Type
Active Comparator
Arm Description
Group of patients to whom was applied Medtronic device during thoracoscopic ablation.
Intervention Type
Procedure
Intervention Name(s)
Thoracoscopic surgical ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
The number of intraoperative complications
Description
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)
Time Frame
Day 1
Title
Postoperative complications
Description
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)
Time Frame
1 mounth
Title
Heart rhythm
Description
Heart rhythm (sinus rhythm, atrial fibrillation, pacemaker rhythm)
Time Frame
at the time of discharge
Secondary Outcome Measure Information:
Title
Recurrence of atrial fibrillation
Description
Development of recurrence of atrial fibrillation after thoracoscopic ablation
Time Frame
period after 3 month - 5 year.
Title
Cardiac Remodeling
Description
Assessment cardiac remodeling after thoracoscopic ablation (indexed left atrial volume, ejection fraction, systolic pulmonary artery pressure)
Time Frame
after discharge - 5 year
Title
Functional class of heart failure
Description
Assessment of the functional class of heart failure after thoracoscopic ablation
Time Frame
1-5 year.
Title
Stroke and Transitory ischemic attack
Description
Development of Stroke and Transitory ischemic attack after thoracoscopic ablation
Time Frame
after discharge - 5 year
Title
Unplanned cardiovascular hospitalization
Description
Unplanned non-cardiovascular hospitalization after thoracoscopic ablation
Time Frame
after discharge - 5 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander V Troitskiy, MD, SD
Organizational Affiliation
Federal Research and Clinical Center
Official's Role
Study Director
Facility Information:
Facility Name
Federal State Budget Institution Clinical hospital
City
Moscow
ZIP/Postal Code
107143
Country
Russian Federation
Facility Name
Federal Research Clinical Center of Federal Medical & Biological Agency
City
Moscow
ZIP/Postal Code
115682
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no current plan to share individual participant data (IPD).
Citations:
Citation
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
Results Reference
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Thoracoscopic Ablation for Lone Atrial Fibrillation
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