Thoracoscopic Ablation Versus Catheter Ablation in Patients With Atrial Fibrillation (TACAAF)
Primary Purpose
Atrial Fibrillation, Persistent
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Ablation Index Guided endocardial catheter radiofrequency ablation
minimally invasive thoracoscopic surgical epicardial ablation.
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation, Persistent focused on measuring persistent atrial fibrillation, catheter ablation, thoracoscopic ablation, LAA removal, Box-lesion, ablation index, high-density mapping, hybrid procedure
Eligibility Criteria
Inclusion Criteria:
- Patient is older than 18 years old
- Patient has nonparoxismal atrial fibrillation
- Sympthomatic AF
- Patient is refractory to at least one antiarrhythmic drug
- Indications for catheter or thoracoscopic ablation
- Absence of previous failed catheter or surgical AF ablations
- Patients agreement
Exclusion Criteria:
- Patient is younger than 18 years old
- Contraindications for catheter or thoracoscopic ablation
- Any previous heart surgeries (open/interventional)
- Congenital heart diseases
- Paroxismal AF
Sites / Locations
- A.V. Vishnevsky National Medical Research Center of SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ablation Index guided catheter radiofrequency ablation
Thoracoscopic surgical epicardial ablation
Arm Description
30 patients, who undergo Ablation Index (AI) guided catheter RF ablation
30 patients, who undergo thoracoscopic ablation using "Box-lesion" set
Outcomes
Primary Outcome Measures
Freedom from AF and other atrial tachycardia
Freedom from AF and other atrial tachycardias, lasting more than 60 sec, determined by 24-hour Holter monitoring.
Other atrial tachycardias include left atrial flutters, typical atrial flutters
Major adverse cardiac and cerebral events (MACCE)
MACCE include death, stroke, transitory ischemic attack, hemopericarditis, implantation if pacemaker.
Secondary Outcome Measures
Freedom of AAD
Freedom from any AAD and anticoagulation
Postoperative hospitalization duration
The ammount of days after the procedure, wich were spent in the hospital
Decrease in the frequency of AF episodes
Decrease of the ammount of AF episodes
Full Information
NCT ID
NCT04237389
First Posted
January 15, 2020
Last Updated
January 22, 2020
Sponsor
National Research Center of Surgery, Russia
1. Study Identification
Unique Protocol Identification Number
NCT04237389
Brief Title
Thoracoscopic Ablation Versus Catheter Ablation in Patients With Atrial Fibrillation
Acronym
TACAAF
Official Title
Comparative Assessment of Catheter and Thoracoscopic Approaches in Patients With Persistent and Long-standing Persistent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2019 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Center of Surgery, Russia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Despite good progress in the management of patients with atrial fibrillation (AF), this arrhythmia remains one of the major causes of stroke, heart failure, sudden death, and cardiovascular morbidity in the world. Furthermore, the number of patients with AF is predicted to rise steply in the coming years.
Even if the amount of antiarrhythmic drugs (AAD) is constantly increasing, there is a group of patients who has AF, resistant to AAD therapy. In such cases they are being offered alternative minimally invasive procedures, such as catheter or thoracoscopic ablation. With the discovery that AF often is initiated and maintained by electrical instability inside and around the pulmonary veins (PV) catheter and thoracoscopic ablation are now widely accepted invasive strategies to cure AF.
Even though the results of both of the procedures are very promising in treating patients with paroxysmal AF, the decision making process, which approach should be used in patients with persistant or LSPAF, is still very controversial.
According to 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS, catheter or surgical ablation should be considered in patients with symptomatic persistent or long-standing persistent (LSP) AF refractory to AAD therapy to improve symptoms, considering patient choice, benefit and risk, supported by an AF Heart Team (IIaC).
Since, there is no actual evidence base, which approach is more effective and save in patients with persistant and LSP AF, the aim of the investigator's study is to evaluate the results of both of the approaches in such group of patients.
Detailed Description
The aim of this study is to compare 2 approaches for AF treatment, endocardial catheter isolation of the pulmonary veins (PV) versus minimally invasive thoracoscopic surgical epicardial ablation.
The patients in both groups will be comparable and have persistant or LSP AF only. Patients with previous catheter ablations or any interventions or open heart procedures in the anamnesis will be excluded. The catheter ablation will be Ablation Index-guided, which means that every ablation point will be taken according to ablation quality marker which corporates power, delivery time, contact force (CF), and catheter stability, called Ablation Index (AI). Both of the procedures will be performed by a single identical protocol including wide complete circumferential ablation around the right and left PVs, and additional lines between the lower and upper PVs. The thoracoscopic procedure will be supplemented with removal of left atrial appendage (LAA).
In cases of AF or other atrial tachycardia recurrence after both procedures, every patient will undergo the opposite procedure (for example, if patient after thoracoscopic ablation will be diagnosed an AF recurrence, he will undergo catheter ablation). That is why there will be the third group, the so-called Hybrid procedure group of patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Persistent
Keywords
persistent atrial fibrillation, catheter ablation, thoracoscopic ablation, LAA removal, Box-lesion, ablation index, high-density mapping, hybrid procedure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ablation Index guided catheter radiofrequency ablation
Arm Type
Active Comparator
Arm Description
30 patients, who undergo Ablation Index (AI) guided catheter RF ablation
Arm Title
Thoracoscopic surgical epicardial ablation
Arm Type
Active Comparator
Arm Description
30 patients, who undergo thoracoscopic ablation using "Box-lesion" set
Intervention Type
Procedure
Intervention Name(s)
Ablation Index Guided endocardial catheter radiofrequency ablation
Intervention Description
Ablation Index (AI) guided catheter RF ablation with circumferential ablation around the right and left PVs and 2 additional lines between the lower and upper PVs (endoBox-lesion).
Intervention Type
Procedure
Intervention Name(s)
minimally invasive thoracoscopic surgical epicardial ablation.
Intervention Description
Description: minimally invasive thoracoscopic surgical epicardial ablation using "Box-lesion" set, which includes isolation of the right and left PVs, roof and posterior wall lines and removal of the LAA.
Primary Outcome Measure Information:
Title
Freedom from AF and other atrial tachycardia
Description
Freedom from AF and other atrial tachycardias, lasting more than 60 sec, determined by 24-hour Holter monitoring.
Other atrial tachycardias include left atrial flutters, typical atrial flutters
Time Frame
12 month
Title
Major adverse cardiac and cerebral events (MACCE)
Description
MACCE include death, stroke, transitory ischemic attack, hemopericarditis, implantation if pacemaker.
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Freedom of AAD
Description
Freedom from any AAD and anticoagulation
Time Frame
12 month
Title
Postoperative hospitalization duration
Description
The ammount of days after the procedure, wich were spent in the hospital
Time Frame
2 month
Title
Decrease in the frequency of AF episodes
Description
Decrease of the ammount of AF episodes
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is older than 18 years old
Patient has nonparoxismal atrial fibrillation
Sympthomatic AF
Patient is refractory to at least one antiarrhythmic drug
Indications for catheter or thoracoscopic ablation
Absence of previous failed catheter or surgical AF ablations
Patients agreement
Exclusion Criteria:
Patient is younger than 18 years old
Contraindications for catheter or thoracoscopic ablation
Any previous heart surgeries (open/interventional)
Congenital heart diseases
Paroxismal AF
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irina A Taymasova
Phone
+7(916)6028095
Email
irina-tame@yandex.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena A Artyukhina
Organizational Affiliation
A.V. Vishnevsky National Medical Research Center of Surgery
Official's Role
Study Chair
Facility Information:
Facility Name
A.V. Vishnevsky National Medical Research Center of Surgery
City
Moscow
ZIP/Postal Code
11799
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yulia Stepanova
Phone
+7(916)654-84-85
Email
stepanovaua@mail.ru
First Name & Middle Initial & Last Name & Degree
Amiran Sh Revishvili, Academician
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30715255
Citation
Castella M, Kotecha D, van Laar C, Wintgens L, Castillo Y, Kelder J, Aragon D, Nunez M, Sandoval E, Casellas A, Mont L, van Boven WJ, Boersma LVA, van Putte BP. Thoracoscopic vs. catheter ablation for atrial fibrillation: long-term follow-up of the FAST randomized trial. Europace. 2019 May 1;21(5):746-753. doi: 10.1093/europace/euy325.
Results Reference
result
Learn more about this trial
Thoracoscopic Ablation Versus Catheter Ablation in Patients With Atrial Fibrillation
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