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Thoracoscopic Ablation Versus Catheter Ablation in Patients With Atrial Fibrillation (TACAAF)

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ClinicalTrials.gov Identifier: NCT04237389
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Revishvili Amiran Shotaevich, National Research Center of Surgery, Russia

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.


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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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


  2. Major adverse cardiac and cerebral events (MACCE) [ Time Frame: 12 month ]
    MACCE include death, stroke, transitory ischemic attack, hemopericarditis, implantation if pacemaker.


Secondary Outcome Measures :
  1. Freedom of AAD [ Time Frame: 12 month ]
    Freedom from any AAD and anticoagulation

  2. Postoperative hospitalization duration [ Time Frame: 2 month ]
    The ammount of days after the procedure, wich were spent in the hospital

  3. Decrease in the frequency of AF episodes [ Time Frame: 12 month ]
    Decrease of the ammount of AF episodes



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Irina A Taymasova +7(916)6028095 irina-tame@yandex.ru

Locations
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Russian Federation
A.V. Vishnevsky National Medical Research Center of Surgery Recruiting
Moscow, Russian Federation, 11799
Contact: Yulia Stepanova    +7(916)654-84-85    stepanovaua@mail.ru   
Principal Investigator: Amiran Sh Revishvili, Academician         
Sponsors and Collaborators
National Research Center of Surgery, Russia
Investigators
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Study Chair: Elena A Artyukhina A.V. Vishnevsky National Medical Research Center of Surgery
Publications of Results:
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Responsible Party: Revishvili Amiran Shotaevich, M.D., Ph.D., Academician of the Russian Academy of Science, Head of the A.V. Vishnevsky National Medical Research Center of Surgery, National Research Center of Surgery, Russia
ClinicalTrials.gov Identifier: NCT04237389    
Other Study ID Numbers: NRCSRussia02
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Revishvili Amiran Shotaevich, National Research Center of Surgery, Russia:
persistent atrial fibrillation
catheter ablation
thoracoscopic ablation
LAA removal
Box-lesion
ablation index
high-density mapping
hybrid procedure
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes