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

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation, Persistent
• Intervention / Treatment: Procedure: Ablation Index Guided endocardial catheter radiofrequency ablation; Procedure: minimally invasive thoracoscopic surgical epicardial ablation.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Irina A Taymasova; Phone Number: +7(916)6028095; Email: irina-tame@yandex.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 11799
    • Recruiting
    • A.V. Vishnevsky National Medical Research Center of Surgery
    • Contact: Yulia Stepanova; Phone Number: +7(916)654-84-85; Email: stepanovaua@mail.ru
    • Principal Investigator: Amiran Sh Revishvili, Academician

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom of AAD	Freedom from any AAD and anticoagulation	12 month
Postoperative hospitalization duration	The ammount of days after the procedure, wich were spent in the hospital	2 month
Decrease in the frequency of AF episodes	Decrease of the ammount of AF episodes	12 month

Collaborators and Investigators

• Sponsor: National Research Center of Surgery, Russia
• Investigators: Study Chair: Elena A Artyukhina, A.V. Vishnevsky National Medical Research Center of Surgery

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2019
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: catheter ablation; persistent atrial fibrillation; thoracoscopic ablation; LAA removal; Box-lesion; ablation index; high-density mapping; hybrid procedure
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: NRCSRussia02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No