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Thoracoscopic Versus Endocardial Ablation in Patient With Paroxysmal AF After Failed Initial Endocardial Ablation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier:
NCT01794416
First received: February 15, 2013
Last updated: March 24, 2013
Last verified: March 2013

February 15, 2013
March 24, 2013
May 2011
March 2013   (final data collection date for primary outcome measure)
freedom from any atrial arrhythmia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01794416 on ClinicalTrials.gov Archive Site
  • rate of significant adverse events (SAEs) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • atrial fibrillation burden by ILR [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Thoracoscopic Versus Endocardial Ablation in Patient With Paroxysmal AF After Failed Initial Endocardial Ablation
Thoracoscopic Ablation Versus Endocardial Ablation in Patient With Paroxysmal Atrial Fibrillation After Failed Initial Endocardial Ablation

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Paroxysmal Atrial Fibrillation
  • Procedure: Thoracoscopic epicardial ablation
  • Procedure: Endocardial catheter ablation
  • Device: Implantable loop recorder
  • Active Comparator: Thoracoscopic epicardial ablation

    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.

    Interventions:
    • Procedure: Thoracoscopic epicardial ablation
    • Device: Implantable loop recorder
  • Active Comparator: Endocardial catheter ablation
    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.
    Interventions:
    • Procedure: Endocardial catheter ablation
    • Device: Implantable loop recorder
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • failed initial catheter ablation
  • paroxysmal atrial fibrillation

Exclusion Criteria:

  • 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%
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01794416
TA-EA-001
Yes
Meshalkin Research Institute of Pathology of Circulation
Meshalkin Research Institute of Pathology of Circulation
Not Provided
Principal Investigator: Evgeny Pokushalov, MD, PhD State Research Institute of Circulation Pathology
Meshalkin Research Institute of Pathology of Circulation
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP