NCT01794416

Brief Summary

The investigators aimed to compare two approaches thoracoscopic epicardial ablation and endocardial catheter ablation after failed initial catheter ablation in patients with paroxysmal atrial fibrillation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

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
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2013

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 26, 2013

Status Verified

March 1, 2013

Enrollment Period

1.8 years

First QC Date

February 15, 2013

Last Update Submit

March 24, 2013

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • freedom from any atrial arrhythmia

    12 months

Secondary Outcomes (2)

  • rate of significant adverse events (SAEs)

    12 months

  • atrial fibrillation burden by ILR

    12 months

Study Arms (2)

Thoracoscopic epicardial ablation

ACTIVE COMPARATOR

Patients were treated with video-assisted thoracoscopy under general anesthesia. PVI was performed from the epicardial side with a bipolar RF ablation clamp (AtriCure). 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. An additional application was made in the interatrial Waterston groove in the right side to isolate the ganglionic plexi from the atria. On the left side, the ligament of Marshal was cut, but no additional ablation of ganglionic plexi was pursued. The RevealXT (implantable loop recorder) was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check.

Procedure: Thoracoscopic epicardial ablationDevice: Implantable loop recorder

Endocardial catheter ablation

ACTIVE COMPARATOR

Externally-irrigated tip (5-mm tip, Celsius Thermo-Cool, Biosense Webster, Diamond Bar, CA, USA). Temperature-controlled RF delivery was performed with a maximum power output of 50 W and temperature limit of 50 C. The catheter was irrigated using 0.9% saline infusion at a flow rate of 20-40 mL/min during RF delivery and 2 mL/min between applications using a commercially available pump (Cool Flow, Biosense Webster). The RevealXT (implantable loop recorder) was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check.

Procedure: Endocardial catheter ablationDevice: Implantable loop recorder

Interventions

Thoracoscopic epicardial ablationPROCEDURE
Thoracoscopic epicardial ablation
Endocardial catheter ablationPROCEDURE
Endocardial catheter ablation
Implantable loop recorderDEVICE
Endocardial catheter ablationThoracoscopic epicardial ablation

Eligibility Criteria

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

You may qualify if:

  • failed initial catheter ablation
  • paroxysmal atrial fibrillation

You may not qualify if:

  • chronic lung disease
  • body mass index \>35
  • longstanding atrial fibrillation 1 year
  • previous stroke or transient ischemic attack
  • left atrial thrombus
  • left atrial size \>65 mm
  • left ventricular ejection fraction \<35%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

Location

Related Publications (1)

  • Pokushalov E, Romanov A, Elesin D, Bogachev-Prokophiev A, Losik D, Bairamova S, Karaskov A, Steinberg JS. Catheter versus surgical ablation of atrial fibrillation after a failed initial pulmonary vein isolation procedure: a randomized controlled trial. J Cardiovasc Electrophysiol. 2013 Dec;24(12):1338-43. doi: 10.1111/jce.12245. Epub 2013 Sep 9.

    PMID: 24016147DERIVED

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Evgeny Pokushalov, MD, PhD

    State Research Institute of Circulation Pathology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2013

First Posted

February 18, 2013

Study Start

May 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 26, 2013

Record last verified: 2013-03

Locations

RU(1)