MedTrace Logo

Thoracoscopic Ablation Versus Catheter Ablation in Patients With Atrial Fibrillation

NCT04237389 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-01-23

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation, Persistent

Interventions

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).

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.

Sponsors & Collaborators

  • National Research Center of Surgery, Russia

    lead OTHER_GOV

Principal Investigators

  • Elena A Artyukhina · A.V. Vishnevsky National Medical Research Center of Surgery

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-22
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • Russia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04237389 on ClinicalTrials.gov