Thoracoscopic Ablation Versus Catheter Ablation in Patients With Atrial Fibrillation (TACAAF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04237389|
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : January 23, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation, Persistent||Procedure: Ablation Index Guided endocardial catheter radiofrequency ablation Procedure: minimally invasive thoracoscopic surgical epicardial ablation.||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Assessment of Catheter and Thoracoscopic Approaches in Patients With Persistent and Long-standing Persistent Atrial Fibrillation|
|Actual Study Start Date :||March 22, 2019|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||August 31, 2022|
Active Comparator: Ablation Index guided catheter radiofrequency ablation
30 patients, who undergo Ablation Index (AI) guided catheter RF ablation
Procedure: Ablation Index Guided endocardial catheter radiofrequency ablation
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).
Active Comparator: Thoracoscopic surgical epicardial ablation
30 patients, who undergo thoracoscopic ablation using "Box-lesion" set
Procedure: minimally invasive thoracoscopic surgical epicardial ablation.
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.
- Freedom from AF and other atrial tachycardia [ Time Frame: 12 month ]
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) [ Time Frame: 12 month ]MACCE include death, stroke, transitory ischemic attack, hemopericarditis, implantation if pacemaker.
- Freedom of AAD [ Time Frame: 12 month ]Freedom from any AAD and anticoagulation
- Postoperative hospitalization duration [ Time Frame: 2 month ]The ammount of days after the procedure, wich were spent in the hospital
- Decrease in the frequency of AF episodes [ Time Frame: 12 month ]Decrease of the ammount of AF episodes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04237389
|Contact: Irina A Taymasova||+7(916)email@example.com|
|A.V. Vishnevsky National Medical Research Center of Surgery||Recruiting|
|Moscow, Russian Federation, 11799|
|Contact: Yulia Stepanova +7(916)654-84-85 firstname.lastname@example.org|
|Principal Investigator: Amiran Sh Revishvili, Academician|
|Study Chair:||Elena A Artyukhina||A.V. Vishnevsky National Medical Research Center of Surgery|