Study Stopped
Early termination was granted by FDA based on study results meeting the post approval requirements.
Longitudinal Surveillance Registry (LSR) of ACUITY Spiral
Condition of Approval Study: Longitudinal Surveillance Registry of the ACUITY Spiral Lead
1 other identifier
observational
1,308
1 country
97
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2009
Longer than P75 for all trials
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2009
CompletedStudy Start
First participant enrolled
August 4, 2009
CompletedFirst Posted
Study publicly available on registry
August 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2018
CompletedResults Posted
Study results publicly available
May 2, 2019
CompletedMay 2, 2019
July 1, 2018
8.6 years
August 4, 2009
July 10, 2018
January 31, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Chronic Left Ventricular Lead-related Complication Free Rate
Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death).
Study Arms (1)
Implants
Patients successfully implanted with the ACUITY Spiral Lead
Interventions
Eligibility Criteria
The population will be a broad base representative of those recieving the ACUITY Spiral lead.
You may qualify if:
- 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
You may not qualify if:
- Is unable or unwilling to comply with the protocol requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (97)
Birmingham Heart Clinic
Birmingham, Alabama, 35235, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
Tri-City Cardiology
Mesa, Arizona, 85206, United States
Arizona Arrhythmia Research Center
Scottsdale, Arizona, 85258, United States
Pima Heart Physicians
Tucson, Arizona, 85712, United States
Cardiology Associates of Northeast Arkansas
Jonesboro, Arkansas, 72401, United States
Heart Clinic Arkansas
Little Rock, Arkansas, 72205, United States
Comprehensive Cardiovascular Medical Group
Bakersfield, California, 93309, United States
Belott Cardiology
El Cajon, California, 92021, United States
Fullerton Cardiovascular
Fullerton, California, 92835, United States
Cardiac Device Rhythm Specialists
Los Angeles, California, 90033, United States
Cedars - Sinai Medical Center
Los Angeles, California, 90048, United States
Memorial Hospital
Modesto, California, 95355, United States
Cardiac Rhythm Specialists, Inc.
Northridge, California, 91325, United States
Cardiovascular Consultants
Oakland, California, 94609, United States
Orange County Heart Institute
Orange, California, 92868, United States
Eisenhower Medical Center
Rancho Mirage, California, 92270, United States
Truong D Duong Cardiac Electrophysiology
Riverside, California, 92501, United States
Regional Cardiology Associates
Sacramento, California, 95819, United States
Sansum Clinic
Santa Barbara, California, 93102, United States
Bethesda Memorial Hospital
Atlantis, Florida, 33462, United States
Heart and Vascular Institute of Florida
Clearwater, Florida, 33756, United States
Miami International Cardiology Consultants
Miami, Florida, 33137, United States
Complete Cardiology Care
New Smyrna Beach, Florida, 32168, United States
Orlando Regional Hospital
Orlando, Florida, 32806, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308, United States
West Coast Arrhythmia Center
Trinity, Florida, 34655, United States
Phoebe Putney Memorial Hospital
Albany, Georgia, 31701, United States
Medical College of Georgia Health
Augusta, Georgia, 30912, United States
Northeast Georgia Heart Center
Gainesville, Georgia, 30501, United States
Georgia Arrhythmia Consultants
Macon, Georgia, 31201, United States
St Lukes Idaho Cardiology Assoc.
Boise, Idaho, 83712, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007, United States
Heart Care Research Foundation
Mokena, Illinois, 60448, United States
Northern Indiana Research Alliance
Fort Wayne, Indiana, 46804, United States
St. Mary Medical Center - Indiana
Hobart, Indiana, 46342, United States
Via-Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Southern Kentucky Heart Institute
Bowling Green, Kentucky, 42101, United States
Central Baptist Hospital
Lexington, Kentucky, 40503, United States
St. Joseph Hospital
Lexington, Kentucky, 40504, United States
Commonwealth Cardiology
Louisville, Kentucky, 40202, United States
Baltimore Heart Association
Randallstown, Maryland, 21133, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Steward St. Elizabeth's Medical Center
Boston, Massachusetts, 02135, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
Heart Care
Detroit, Michigan, 48201, United States
Cardiology Consultants of East Michigan
Flint, Michigan, 48507, United States
West Michigan Heart
Grand Rapids, Michigan, 49301, United States
Providence Hospital
Southfield, Michigan, 48075, United States
St. Mary's Duluth Clinic
Duluth, Minnesota, 55805, United States
Missouri Heart Center
Columbia, Missouri, 65201, United States
Research Medical Center
Kansas City, Missouri, 64114, United States
Cox Health
Springfield, Missouri, 65807, United States
Metro Heart Group South County
St Louis, Missouri, 63128, United States
Nebraska Heart Institute
Lincoln, Nebraska, 68526, United States
New Jersey Cardiology Associates
West Orange, New Jersey, 07052, United States
Capital Cardiology Associates
Albany, New York, 12208, United States
Island Cardiac Specialists
Garden City, New York, 11530, United States
Columbia University Medical Center
New York, New York, 10032, United States
Mid-Carolina Cardiology
Charlotte, North Carolina, 28204, United States
Pinehurst Cardiology Consultants
Pinehurst, North Carolina, 28374, United States
Christ Hospital - Cincinnati
Cincinnati, Ohio, 45219, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Regional Cardiovascular Medical Center
Steubenville, Ohio, 43952, United States
Genesis Healthcare System
Zanesville, Ohio, 43701, United States
Hillcrest Medical Center
Tulsa, Oklahoma, 74101, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Associated Cardiologists
Harrisburg, Pennsylvania, 17112, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
Cardiovascular Associates of Rhode Island
Providence, Rhode Island, 02904, United States
Columbia Cardiology
Columbia, South Carolina, 29204, United States
PeeDee Cardiology Associates
Florence, South Carolina, 29505, United States
Heart Doctors
Rapid City, South Dakota, 57701, United States
Memphis Heart Clinic
Memphis, Tennessee, 37501, United States
Amarillo Heart Group
Amarillo, Texas, 79106, United States
Texas Cardiac Arrhythmia Research
Austin, Texas, 78705, United States
Heart Hospital of Austin
Austin, Texas, 78756, United States
Cardiology Care Consultants
El Paso, Texas, 79902, United States
Hall Garcia Cardiology
Houston, Texas, 77030, United States
Houston Electrophysiology Associates
Houston, Texas, 77030, United States
Willowbrook Cardiovascular Associates
Houston, Texas, 77030, United States
EP Heart
The Woodlands, Texas, 77384, United States
Tyler Cardiovascular Consultants
Tyler, Texas, 75701, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
Dixie Regional Medical Center
St. George, Utah, 84790, United States
Virginia Heart
Falls Church, Virginia, 22042, United States
Richmond Cardiology Associates
Mechanicsville, Virginia, 23116, United States
Overlake Medical Center
Bellevue, Washington, 98004, United States
St. Joseph Hospital
Bellingham, Washington, 98225, United States
Swedish Medical Center
Seattle, Washington, 98133, United States
Heart Clinics Northwest
Spokane, Washington, 99204, United States
Wheaton Franciscan Healthcare
Wauwatosa, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Early termination was granted based on study results. The study was one-armed observational. The expected performance / safety of left ventricular leads has been established; permitting comparison to a pre-defined performance standard.
Results Point of Contact
- Title
- Director of Clinical Trial Management - cRM franchise
- Organization
- Boston Scientific
Study Officials
- STUDY DIRECTOR
Olaf Hedrich, MD
Boston Scientific Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2009
First Posted
August 10, 2009
Study Start
August 4, 2009
Primary Completion
February 28, 2018
Study Completion
February 28, 2018
Last Updated
May 2, 2019
Results First Posted
May 2, 2019
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share