Thoracoscopic Ablation Versus Catheter Ablation in Patients With Atrial Fibrillation

Atrial Fibrillation, Persistent Clinical Trial

— TACAAF  

Official title:

Comparative Assessment of Catheter and Thoracoscopic Approaches in Patients With Persistent and Long-standing Persistent Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04237389
• Other study ID #: NRCSRussia02
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: January 2020
• Source: National Research Center of Surgery, Russia
• Contact: Irina A Taymasova
• Phone: +7(916)6028095
• Email: irina-tame[@]yandex.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation, Persistent

Intervention

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).
• 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.

Locations

Country	Name	City	State
Russian Federation	A.V. Vishnevsky National Medical Research Center of Surgery	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
National Research Center of Surgery, Russia

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

Castellá M, Kotecha D, van Laar C, Wintgens L, Castillo Y, Kelder J, Aragon D, Nuñez 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 r — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Major adverse cardiac and cerebral events (MACCE)	MACCE include death, stroke, transitory ischemic attack, hemopericarditis, implantation if pacemaker.	12 month
Secondary	Freedom of AAD	Freedom from any AAD and anticoagulation	12 month
Secondary	Postoperative hospitalization duration	The ammount of days after the procedure, wich were spent in the hospital	2 month
Secondary	Decrease in the frequency of AF episodes	Decrease of the ammount of AF episodes	12 month