NCT02562391

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for phase_2 atrial-fibrillation

Timeline
Completed

Started May 2011

Longer than P75 for phase_2 atrial-fibrillation

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

4 years

First QC Date

September 24, 2015

Last Update Submit

September 25, 2015

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationablationthoracoscopyleft atrial appendage

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation recurrences

    18 months

Study Arms (2)

PVI+Box lesions

ACTIVE COMPARATOR

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.

Device: Surgical ablation of the left atrium (PVI+Box lesions)

PVI+Box lesions+LAA cutting

EXPERIMENTAL

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.

Device: Surgical ablation of the left atrium (PVI+Box lesions) and left atrial appendage cutting

Interventions

Surgical ablation of the left atrium (PVI+Box lesions)DEVICE
PVI+Box lesions
Surgical ablation of the left atrium (PVI+Box lesions) and left atrial appendage cuttingDEVICE
PVI+Box lesions+LAA cutting

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Federal Center of Cardiovascular surgery

Krasnoyarsk, Russia

Location

Federal State Institution Clinical Hospital of the Presidental Administration of the RF

Moscow, Russia

Location

Scientific center of the cardiovascular surgery named by A.N. Bakulev

Moscow, Russia

Location

State Research Institute of CIrculation Pathology

Novosibirsk, 630055, Russia

Location

Related Publications (1)

  • 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.

    PMID: 27180620DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2015

First Posted

September 29, 2015

Study Start

May 1, 2011

Primary Completion

May 1, 2015

Study Completion

May 1, 2017

Last Updated

September 29, 2015

Record last verified: 2015-09

Locations

RU(4)