search
Back to results

Effect of Left Atrial Appendage Excision on Procedure Outcome in Patients With Persistent and Long-standing Persistent Atrial Fibrillation Undergoing Surgical Ablation

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Surgical ablation of the left atrium (PVI+Box lesions)
Surgical ablation of the left atrium (PVI+Box lesions) and left atrial appendage cutting
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, ablation, thoracoscopy, left atrial appendage

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Patients with persistent and long-standing persistent atrial fibrillation eligible for thoracoscopy surgical ablation
  • Signed inform consent

Key Exclusion Criteria:

  • Paroxysmal atrial fibrillation
  • Contraindications for surgical ablation
  • Unwilling to participate

Sites / Locations

  • Federal Center of Cardiovascular surgery
  • Federal State Institution Clinical Hospital of the Presidental Administration of the RF
  • Scientific center of the cardiovascular surgery named by A.N. Bakulev
  • State Research Institute of CIrculation Pathology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PVI+Box lesions

PVI+Box lesions+LAA cutting

Arm Description

Patients were treated with video-assisted thoracoscopy under general anesthesia, according to a previously described protocol. In brief, PVI was performed from the epicardial side with a bipolar radiofrequency ablation clamp. At least 2 overlapping applications around each of the ipsilateral veins were made, and isolation was confirmed by the absence of PV potentials and exit block during pacing. In addition to PVI, the bilateral epicardial ganglia were found by high-frequency stimulation and ablated, as confirmed by the absence of a vagal response after ablation. Finally additional lines were made to create a posterior box lesion. Sensing and pacing maneuvers verified isolation of the posterior box.

Patients were treated with video-assisted thoracoscopy under general anesthesia, according to a previously described protocol. In brief, PVI was performed from the epicardial side with a bipolar radiofrequency ablation clamp. At least 2 overlapping applications around each of the ipsilateral veins were made, and isolation was confirmed by the absence of PV potentials and exit block during pacing. In addition to PVI, the bilateral epicardial ganglia were found by high-frequency stimulation and ablated, as confirmed by the absence of a vagal response after ablation. Finally additional lines were made to create a posterior box lesion. Sensing and pacing maneuvers verified isolation of the posterior box.The left atrial appendage was removed by stapling and then cutting.

Outcomes

Primary Outcome Measures

Atrial fibrillation recurrences

Secondary Outcome Measures

Full Information

First Posted
September 24, 2015
Last Updated
September 25, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
search

1. Study Identification

Unique Protocol Identification Number
NCT02562391
Brief Title
Effect of Left Atrial Appendage Excision on Procedure Outcome in Patients With Persistent and Long-standing Persistent Atrial Fibrillation Undergoing Surgical Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to assess the effect of left atrial appendage excision on atrial fibrillation recurrence and incidence of stroke in patients with persistent and long-standing persistent atrial fibrillation undergoing surgical ablation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, ablation, thoracoscopy, left atrial appendage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PVI+Box lesions
Arm Type
Active Comparator
Arm Description
Patients were treated with video-assisted thoracoscopy under general anesthesia, according to a previously described protocol. In brief, PVI was performed from the epicardial side with a bipolar radiofrequency ablation clamp. At least 2 overlapping applications around each of the ipsilateral veins were made, and isolation was confirmed by the absence of PV potentials and exit block during pacing. In addition to PVI, the bilateral epicardial ganglia were found by high-frequency stimulation and ablated, as confirmed by the absence of a vagal response after ablation. Finally additional lines were made to create a posterior box lesion. Sensing and pacing maneuvers verified isolation of the posterior box.
Arm Title
PVI+Box lesions+LAA cutting
Arm Type
Experimental
Arm Description
Patients were treated with video-assisted thoracoscopy under general anesthesia, according to a previously described protocol. In brief, PVI was performed from the epicardial side with a bipolar radiofrequency ablation clamp. At least 2 overlapping applications around each of the ipsilateral veins were made, and isolation was confirmed by the absence of PV potentials and exit block during pacing. In addition to PVI, the bilateral epicardial ganglia were found by high-frequency stimulation and ablated, as confirmed by the absence of a vagal response after ablation. Finally additional lines were made to create a posterior box lesion. Sensing and pacing maneuvers verified isolation of the posterior box.The left atrial appendage was removed by stapling and then cutting.
Intervention Type
Device
Intervention Name(s)
Surgical ablation of the left atrium (PVI+Box lesions)
Intervention Type
Device
Intervention Name(s)
Surgical ablation of the left atrium (PVI+Box lesions) and left atrial appendage cutting
Primary Outcome Measure Information:
Title
Atrial fibrillation recurrences
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Patients with persistent and long-standing persistent atrial fibrillation eligible for thoracoscopy surgical ablation Signed inform consent Key Exclusion Criteria: Paroxysmal atrial fibrillation Contraindications for surgical ablation Unwilling to participate
Facility Information:
Facility Name
Federal Center of Cardiovascular surgery
City
Krasnoyarsk
Country
Russian Federation
Facility Name
Federal State Institution Clinical Hospital of the Presidental Administration of the RF
City
Moscow
Country
Russian Federation
Facility Name
Scientific center of the cardiovascular surgery named by A.N. Bakulev
City
Moscow
Country
Russian Federation
Facility Name
State Research Institute of CIrculation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
27180620
Citation
Romanov A, Pokushalov E, Elesin D, Bogachev-Prokophiev A, Ponomarev D, Losik D, Bayramova S, Strelnikov A, Shabanov V, Pidanov O, Kropotkin E, Ivanickii E, Karaskov A, Steinberg JS. Effect of left atrial appendage excision on procedure outcome in patients with persistent atrial fibrillation undergoing surgical ablation. Heart Rhythm. 2016 Sep;13(9):1803-9. doi: 10.1016/j.hrthm.2016.05.012. Epub 2016 May 12.
Results Reference
derived

Learn more about this trial

Effect of Left Atrial Appendage Excision on Procedure Outcome in Patients With Persistent and Long-standing Persistent Atrial Fibrillation Undergoing Surgical Ablation

We'll reach out to this number within 24 hrs