Thoracoscopic Ablation Versus Catheter Ablation in Patients With Atrial Fibrillation
TACAAF
Comparative Assessment of Catheter and Thoracoscopic Approaches in Patients With Persistent and Long-standing Persistent Atrial Fibrillation
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 22, 2019
CompletedFirst Submitted
Initial submission to the registry
January 15, 2020
CompletedFirst Posted
Study publicly available on registry
January 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedJanuary 23, 2020
January 1, 2020
3.4 years
January 15, 2020
January 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
12 month
Major adverse cardiac and cerebral events (MACCE)
MACCE include death, stroke, transitory ischemic attack, hemopericarditis, implantation if pacemaker.
12 month
Secondary Outcomes (3)
Freedom of AAD
12 month
Postoperative hospitalization duration
2 month
Decrease in the frequency of AF episodes
12 month
Study Arms (2)
Ablation Index guided catheter radiofrequency ablation
ACTIVE COMPARATOR30 patients, who undergo Ablation Index (AI) guided catheter RF ablation
Thoracoscopic surgical epicardial ablation
ACTIVE COMPARATOR30 patients, who undergo thoracoscopic ablation using "Box-lesion" set
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient is younger than 18 years old
- Contraindications for catheter or thoracoscopic ablation
- Any previous heart surgeries (open/interventional)
- Congenital heart diseases
- Paroxismal AF
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
A.V. Vishnevsky National Medical Research Center of Surgery
Moscow, 11799, Russia
Related Publications (1)
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.
PMID: 30715255RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Elena A Artyukhina
A.V. Vishnevsky National Medical Research Center of Surgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Ph.D., Academician of the Russian Academy of Science, Head of the A.V. Vishnevsky National Medical Research Center of Surgery
Study Record Dates
First Submitted
January 15, 2020
First Posted
January 23, 2020
Study Start
March 22, 2019
Primary Completion
August 31, 2022
Study Completion
August 31, 2022
Last Updated
January 23, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share