Sole-Therapy Treatment of Atrial Fibrillation (RESTORE SR II)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.
ClinicalTrials.gov Identifier:
NCT00566176
First received: November 30, 2007
Last updated: February 4, 2013
Last verified: February 2013

November 30, 2007
February 4, 2013
October 2005
December 2007   (final data collection date for primary outcome measure)
  • The primary outcome is the feasibility of performing this operation by demonstrating the ability to consistently isolate the right and left PVs using this minimally invasive approach. [ Time Frame: Perioperatively ] [ Designated as safety issue: No ]
  • The primary safety endpoint will be determined by assessing the rate of serious adverse events. [ Time Frame: Discharge/30 Days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00566176 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Sole-Therapy Treatment of Atrial Fibrillation
Thoracoscopically-Assisted Epicardial Bilateral Pulmonary Vein Isolations Using the AtriCure Bipolar System and Exclusion of the Left Atrial Appendage for the Treatment of Atrial Fibrillation

RESTORE SR II is a feasibility study on the minimally invasive use of the AtriCure Bipolar System for PV Isolation on a beating heart for the treatment of all types of atrial fibrillation in a sole therapy operation (not concomitant to another cardiac operation).

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
Device: Surgical Ablation using the AtriCure Bipolar System
Surgical Ablation using the AtriCure Bipolar System
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
February 2017
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female patient between 18 and 80 years of age
  2. Patient with symptomatic AF and failure or intolerance of one or more Class I or Class III AADs and:

    • Who describes 3 or more symptomatic AF episodes during the 6 month period prior to enrollment, with at least 1 electrocardiographically documented episode of AF in the 4 months prior to enrollment or,
    • Who has documented AF within the 6 months proceeding enrollment that did not terminate spontaneously (including patients in continuous AF) or,
    • Who is unwilling or unable to take anticoagulants, with 3 or more symptomatic episodes during the 6 month period prior to enrollment with at least 1 electrocardiographically documented episode of AF in the 4 months prior to enrollment.
  3. Left Atrial Size < 6 cm (determined by echocardiography performed within 60 days of enrollment), unless the LV dysfunction is thought to result (at least in part) from AF
  4. Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography performed within 60 days of enrollment)
  5. Patient is willing and able to provide written informed consent.
  6. Patient has a life expectancy of at least 2 years.
  7. Patient is willing and able to attend the scheduled follow-up visits.
  8. Weight < 325 lbs

Exclusion Criteria:

  1. Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months
  2. Prior cardiac surgery
  3. Patients requiring any open heart procedure (e.g. CABG, valve replacement or repair, atrial septal defect repair, etc.)
  4. Class IV NYHA heart failure symptoms, unless these symptoms are considered to be due to uncontrolled AF
  5. Cerebrovascular accident within previous 6 months
  6. Known carotid artery stenosis greater than 80%
  7. Evidence of significant active infection
  8. Patient unable to undergo TEE
  9. Pregnant woman
  10. Requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia
  11. Presence of thrombus in the left atrium
  12. Patient has co-morbid condition that in the opinion of the investigator poses undue risk of general anesthesia or port access cardiac surgery
  13. Patient is enrolled in another investigational study
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00566176
CP2005-1
Not Provided
AtriCure, Inc.
AtriCure, Inc.
Not Provided
Principal Investigator: Warren Jackman, MD University of Oklamhoma Cardiac Arrythmia Research Institute
Principal Investigator: James Edgerton, MD Medical City Hospital/Cardio Pulmonary Research Science and Technology Institute
AtriCure, Inc.
February 2013

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