Longitudinal Surveillance Registry (LSR) of ACUITY Spiral
- Conditions
- Heart Failure
- Interventions
- Device: ACUITY Spiral Left Ventricular Lead
- Registration Number
- NCT00955708
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The primary purpose of the LSR of ACUITY Spiral is to evaluate and report on the long-term performance of the ACUITY Spiral Left Ventricular Lead.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1308
- Has been or will be implanted with the ACUITY Spiral Lead within 29 days
- Plans to remain in the long-term care of his/her enrolling physician
- Is willing and capable (or appropriate legal representative) of authorizing access to and use of health information as required by an institution's institutional review board (IRB)
- Is willing and capable (or appropriate legal representative) of providing authorization for participation in the registry
- Is unable or unwilling to comply with the protocol requirements
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Implants ACUITY Spiral Left Ventricular Lead Patients successfully implanted with the ACUITY Spiral Lead
- Primary Outcome Measures
Name Time Method Chronic Left Ventricular Lead-related Complication Free Rate Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (96)
Cardiac Device Rhythm Specialists
🇺🇸Los Angeles, California, United States
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Baltimore Heart Association
🇺🇸Randallstown, Maryland, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
Cardiology Associates of Northeast Arkansas
🇺🇸Jonesboro, Arkansas, United States
Arizona Arrhythmia Research Center
🇺🇸Scottsdale, Arizona, United States
Pima Heart Physicians
🇺🇸Tucson, Arizona, United States
Comprehensive Cardiovascular Medical Group
🇺🇸Bakersfield, California, United States
Tri-City Cardiology
🇺🇸Mesa, Arizona, United States
Heart Clinic Arkansas
🇺🇸Little Rock, Arkansas, United States
Belott Cardiology
🇺🇸El Cajon, California, United States
Fullerton Cardiovascular
🇺🇸Fullerton, California, United States
Cardiac Rhythm Specialists, Inc.
🇺🇸Northridge, California, United States
Cedars - Sinai Medical Center
🇺🇸Los Angeles, California, United States
Memorial Hospital
🇺🇸Modesto, California, United States
Orange County Heart Institute
🇺🇸Orange, California, United States
Cardiovascular Consultants
🇺🇸Oakland, California, United States
Eisenhower Medical Center
🇺🇸Rancho Mirage, California, United States
Truong D Duong Cardiac Electrophysiology
🇺🇸Riverside, California, United States
Bethesda Memorial Hospital
🇺🇸Atlantis, Florida, United States
Sansum Clinic
🇺🇸Santa Barbara, California, United States
Tallahassee Memorial Hospital
🇺🇸Tallahassee, Florida, United States
Heart and Vascular Institute of Florida
🇺🇸Clearwater, Florida, United States
Complete Cardiology Care
🇺🇸New Smyrna Beach, Florida, United States
West Coast Arrhythmia Center
🇺🇸Trinity, Florida, United States
St Lukes Idaho Cardiology Assoc.
🇺🇸Boise, Idaho, United States
Medical College of Georgia Health
🇺🇸Augusta, Georgia, United States
Georgia Arrhythmia Consultants
🇺🇸Macon, Georgia, United States
Phoebe Putney Memorial Hospital
🇺🇸Albany, Georgia, United States
Northeast Georgia Heart Center
🇺🇸Gainesville, Georgia, United States
Alexian Brothers Medical Center
🇺🇸Elk Grove Village, Illinois, United States
Heart Care Research Foundation
🇺🇸Mokena, Illinois, United States
Southern Kentucky Heart Institute
🇺🇸Bowling Green, Kentucky, United States
Northern Indiana Research Alliance
🇺🇸Fort Wayne, Indiana, United States
St. Mary Medical Center - Indiana
🇺🇸Hobart, Indiana, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
St. Joseph Hospital
🇺🇸Bellingham, Washington, United States
Cardiology Consultants of East Michigan
🇺🇸Flint, Michigan, United States
West Michigan Heart
🇺🇸Grand Rapids, Michigan, United States
Missouri Heart Center
🇺🇸Columbia, Missouri, United States
St. Mary's Duluth Clinic
🇺🇸Duluth, Minnesota, United States
Providence Hospital
🇺🇸Southfield, Michigan, United States
Research Medical Center
🇺🇸Kansas City, Missouri, United States
Cox Health
🇺🇸Springfield, Missouri, United States
Metro Heart Group South County
🇺🇸Saint Louis, Missouri, United States
Nebraska Heart Institute
🇺🇸Lincoln, Nebraska, United States
New Jersey Cardiology Associates
🇺🇸West Orange, New Jersey, United States
Capital Cardiology Associates
🇺🇸Albany, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Mid-Carolina Cardiology
🇺🇸Charlotte, North Carolina, United States
Pinehurst Cardiology Consultants
🇺🇸Pinehurst, North Carolina, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Regional Cardiovascular Medical Center
🇺🇸Steubenville, Ohio, United States
Genesis Healthcare System
🇺🇸Zanesville, Ohio, United States
Hillcrest Medical Center
🇺🇸Tulsa, Oklahoma, United States
Cardiovascular Associates of Rhode Island
🇺🇸Providence, Rhode Island, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Associated Cardiologists
🇺🇸Harrisburg, Pennsylvania, United States
Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
PeeDee Cardiology Associates
🇺🇸Florence, South Carolina, United States
Columbia Cardiology
🇺🇸Columbia, South Carolina, United States
Heart Doctors
🇺🇸Rapid City, South Dakota, United States
Memphis Heart Clinic
🇺🇸Memphis, Tennessee, United States
Amarillo Heart Group
🇺🇸Amarillo, Texas, United States
Heart Hospital of Austin
🇺🇸Austin, Texas, United States
Cardiology Care Consultants
🇺🇸El Paso, Texas, United States
EP Heart
🇺🇸The Woodlands, Texas, United States
Tyler Cardiovascular Consultants
🇺🇸Tyler, Texas, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Dixie Regional Medical Center
🇺🇸Saint George, Utah, United States
Virginia Heart
🇺🇸Falls Church, Virginia, United States
Richmond Cardiology Associates
🇺🇸Mechanicsville, Virginia, United States
Overlake Medical Center
🇺🇸Bellevue, Washington, United States
Heart Clinics Northwest
🇺🇸Spokane, Washington, United States
Wheaton Franciscan Healthcare
🇺🇸Wauwatosa, Wisconsin, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Steward St. Elizabeth's Medical Center
🇺🇸Boston, Massachusetts, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Hall Garcia Cardiology
🇺🇸Houston, Texas, United States
Houston Electrophysiology Associates
🇺🇸Houston, Texas, United States
Willowbrook Cardiovascular Associates
🇺🇸Houston, Texas, United States
Miami International Cardiology Consultants
🇺🇸Miami, Florida, United States
Christ Hospital - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Via-Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Heart Care
🇺🇸Detroit, Michigan, United States
Birmingham Heart Clinic
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Island Cardiac Specialists
🇺🇸Garden City, New York, United States
Regional Cardiology Associates
🇺🇸Sacramento, California, United States
Orlando Regional Hospital
🇺🇸Orlando, Florida, United States
Commonwealth Cardiology
🇺🇸Louisville, Kentucky, United States
St. Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Texas Cardiac Arrhythmia Research
🇺🇸Austin, Texas, United States