Sole-Therapy Treatment of Atrial Fibrillation

NCT00566176 | Unknown Phase 2

• 1 other identifier: CP2005-1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 5

Brief Summary

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).

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; AF; AFIB; racing heart; pulmonary vein isolation; pvi; mini maze; maze

Outcome Measures

Primary Outcomes (2)

• 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.

  Perioperatively

• The primary safety endpoint will be determined by assessing the rate of serious adverse events.

  Discharge/30 Days

Interventions

Surgical Ablation using the AtriCure Bipolar System DEVICE

Surgical Ablation using the AtriCure Bipolar System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient between 18 and 80 years of age
• 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.
• 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
• Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography performed within 60 days of enrollment)
• Patient is willing and able to provide written informed consent.
• Patient has a life expectancy of at least 2 years.
• Patient is willing and able to attend the scheduled follow-up visits.
• Weight \< 325 lbs

You may not qualify if:

• Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months
• Prior cardiac surgery
• Patients requiring any open heart procedure (e.g. CABG, valve replacement or repair, atrial septal defect repair, etc.)
• Class IV NYHA heart failure symptoms, unless these symptoms are considered to be due to uncontrolled AF
• Cerebrovascular accident within previous 6 months
• Known carotid artery stenosis greater than 80%
• Evidence of significant active infection
• Patient unable to undergo TEE
• Pregnant woman
• Requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia
• Presence of thrombus in the left atrium
• Patient has co-morbid condition that in the opinion of the investigator poses undue risk of general anesthesia or port access cardiac surgery
• Patient is enrolled in another investigational study

Sponsors & Collaborators

• AtriCure, Inc.: lead

Study Sites (5)

University Community Hospital/Dr. Kiran C. Patel Research Institute

Tampa, Florida, 33616, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

University of Oklahoma Cardiac Arrythmia Research Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Sacred Heart Medical Center Endovascular Research

Eugene, Oregon, 97401, United States

Location

Medical City Hospital/Cardio Pulmonary Research Science and Technology Institute

Dallas, Texas, 75230, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2007
• First Posted: December 3, 2007
• Study Start: October 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: February 1, 2017
• Last Updated: February 5, 2013

Record last verified: 2013-02

Locations

US (5)