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
  Purpose

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.


Condition Intervention Phase
Paroxysmal Atrial Fibrillation
Procedure: Thoracoscopic epicardial ablation
Procedure: Endocardial catheter ablation
Device: Implantable loop recorder
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Thoracoscopic Ablation Versus Endocardial Ablation in Patient With Paroxysmal Atrial Fibrillation After Failed Initial Endocardial Ablation

Resource links provided by NLM:


Further study details as provided by Meshalkin Research Institute of Pathology of Circulation:

Primary Outcome Measures:
  • freedom from any atrial arrhythmia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: May 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
Procedure: Endocardial catheter ablation Device: Implantable loop recorder

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01794416

Locations
Russian Federation
State Research Institute of Circulation Pathology
Novosibirsk, Russian Federation, 630055
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
Principal Investigator: Evgeny Pokushalov, MD, PhD State Research Institute of Circulation Pathology
  More Information

Additional Information:
No publications provided by Meshalkin Research Institute of Pathology of Circulation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01794416     History of Changes
Other Study ID Numbers: TA-EA-001
Study First Received: February 15, 2013
Last Updated: March 24, 2013
Health Authority: Russia: Ethics Committee

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014