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
  Purpose

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).


Condition Intervention Phase
Atrial Fibrillation
Device: Surgical Ablation using the AtriCure Bipolar System
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AtriCure, Inc.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 25
Study Start Date: October 2005
Estimated Study Completion Date: February 2017
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Surgical Ablation using the AtriCure Bipolar System
    Surgical Ablation using the AtriCure Bipolar System
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00566176

Locations
United States, Florida
University Community Hospital/Dr. Kiran C. Patel Research Institute
Tampa, Florida, United States, 33616
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
United States, Oklahoma
University of Oklahoma Cardiac Arrythmia Research Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Sacred Heart Medical Center Endovascular Research
Eugene, Oregon, United States, 97401
United States, Texas
Medical City Hospital/Cardio Pulmonary Research Science and Technology Institute
Dallas, Texas, United States, 75230
Sponsors and Collaborators
AtriCure, Inc.
Investigators
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
  More Information

No publications provided

Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT00566176     History of Changes
Other Study ID Numbers: CP2005-1
Study First Received: November 30, 2007
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AtriCure, Inc.:
Atrial Fibrillation
AF
AFIB
racing heart
pulmonary vein isolation
pvi
mini maze
maze

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

ClinicalTrials.gov processed this record on September 18, 2014