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Thoracoscopic Ablation Versus Catheter Ablation in Patients With Atrial Fibrillation

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04237389
Acronym
TACAAF
Enrollment
60
Registered
2020-01-23
Start date
2019-03-22
Completion date
2022-08-31
Last updated
2020-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Persistent

Keywords

persistent atrial fibrillation, catheter ablation, thoracoscopic ablation, LAA removal, Box-lesion, ablation index, high-density mapping, hybrid procedure

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.

Interventions

PROCEDUREAblation 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).

PROCEDUREminimally 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.

Sponsors

National Research Center of Surgery, Russia
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Freedom from AF and other atrial tachycardia12 monthFreedom 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)12 monthMACCE include death, stroke, transitory ischemic attack, hemopericarditis, implantation if pacemaker.

Secondary

MeasureTime frameDescription
Freedom of AAD12 monthFreedom from any AAD and anticoagulation
Postoperative hospitalization duration2 monthThe ammount of days after the procedure, wich were spent in the hospital
Decrease in the frequency of AF episodes12 monthDecrease of the ammount of AF episodes

Countries

Russia

Contacts

Primary ContactIrina A Taymasova
irina-tame@yandex.ru+7(916)6028095

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026