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Trial record 1 of 1 for:    NCT00955708
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Longitudinal Surveillance Registry (LSR) of ACUITY Spiral

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00955708
First received: August 4, 2009
Last updated: June 5, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention
Heart Failure Device: ACUITY Spiral Left Ventricular Lead

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Condition of Approval Study: Longitudinal Surveillance Registry of the ACUITY Spiral Lead

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Chronic lead-related complication free rate [ Time Frame: 5 years of follow-up ]

Enrollment: 1308
Actual Study Start Date: August 4, 2009
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Implants
Patients successfully implanted with the ACUITY Spiral Lead
Device: ACUITY Spiral Left Ventricular Lead
The implant of the ACUITY Spiral Lead

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population will be a broad base representative of those recieving the ACUITY Spiral lead.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Is unable or unwilling to comply with the protocol requirements
  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: NCT00955708

  Hide Study Locations
Locations
United States, Alabama
Birmingham Heart Clinic
Birmingham, Alabama, United States, 35235
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Alaska
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
United States, Arizona
Tri-City Cardiology
Mesa, Arizona, United States, 85206
Arizona Arrhythmia Research Center
Scottsdale, Arizona, United States, 85258
Pima Heart Physicians
Tucson, Arizona, United States, 85712
United States, Arkansas
Cardiology Associates of Northeast Arkansas
Jonesboro, Arkansas, United States, 72401
Heart Clinic Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Comprehensive Cardiovascular Medical Group
Bakersfield, California, United States, 93309
Belott Cardiology
El Cajon, California, United States, 92021
Fullerton Cardiovascular
Fullerton, California, United States, 92835
Cardiac Device Rhythm Specialists
Los Angeles, California, United States, 90033
Cedars - Sinai Medical Center
Los Angeles, California, United States, 90048
Memorial Hospital
Modesto, California, United States, 95355
Cardiac Rhythm Specialists, Inc.
Northridge, California, United States, 91325
Cardiovascular Consultants
Oakland, California, United States, 94609
Orange County Heart Institute
Orange, California, United States, 92868
Eisenhower Medical Center
Rancho Mirage, California, United States, 92270
Truong D Duong Cardiac Electrophysiology
Riverside, California, United States, 92501
Regional Cardiology Associates
Sacramento, California, United States, 95819
Sansum Clinic
Santa Barbara, California, United States, 93102
United States, Florida
Bethesda Memorial Hospital
Atlantis, Florida, United States, 33462
Heart and Vascular Institute of Florida
Clearwater, Florida, United States, 33756
Miami International Cardiology Consultants
Miami, Florida, United States, 33137
Complete Cardiology Care
New Smyrna Beach, Florida, United States, 32168
Orlando Regional Hospital
Orlando, Florida, United States, 32806
Tallahassee Memorial Hospital
Tallahassee, Florida, United States, 32308
West Coast Arrhythmia Center
Trinity, Florida, United States, 34655
United States, Georgia
Phoebe Putney Memorial Hospital
Albany, Georgia, United States, 31701
Medical College of Georgia Health
Augusta, Georgia, United States, 30912
Northeast Georgia Heart Center
Gainesville, Georgia, United States, 30501
Georgia Arrhythmia Consultants
Macon, Georgia, United States, 31201
United States, Idaho
St Lukes Idaho Cardiology Assoc.
Boise, Idaho, United States, 83712
United States, Illinois
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States, 60007
Heart Care Research Foundation
Mokena, Illinois, United States, 60448
United States, Indiana
Northern Indiana Research Alliance
Fort Wayne, Indiana, United States, 46804
St. Mary Medical Center - Indiana
Hobart, Indiana, United States, 46342
United States, Kansas
Via-Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Kentucky
Southern Kentucky Heart Institute
Bowling Green, Kentucky, United States, 42101
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
St. Joseph Hospital
Lexington, Kentucky, United States, 40504
Commonwealth Cardiology
Louisville, Kentucky, United States, 40202
United States, Maryland
Baltimore Heart Association
Randallstown, Maryland, United States, 21133
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Steward St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
United States, Michigan
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
Heart Care
Detroit, Michigan, United States, 48201
Cardiology Consultants of East Michigan
Flint, Michigan, United States, 48507
West Michigan Heart
Grand Rapids, Michigan, United States, 49301
Providence Hospital
Southfield, Michigan, United States, 48075
United States, Minnesota
St. Mary's Duluth Clinic
Duluth, Minnesota, United States, 55805
United States, Missouri
Missouri Heart Center
Columbia, Missouri, United States, 65201
Research Medical Center
Kansas City, Missouri, United States, 64114
Metro Heart Group South County
Saint Louis, Missouri, United States, 63128
Cox Health
Springfield, Missouri, United States, 65807
United States, Nebraska
Nebraska Heart Institute
Lincoln, Nebraska, United States, 68526
United States, New Jersey
New Jersey Cardiology Associates
West Orange, New Jersey, United States, 07052
United States, New York
Capital Cardiology Associates
Albany, New York, United States, 12208
Island Cardiac Specialists
Garden City, New York, United States, 11530
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Mid-Carolina Cardiology
Charlotte, North Carolina, United States, 28204
Pinehurst Cardiology Consultants
Pinehurst, North Carolina, United States, 28374
United States, Ohio
Christ Hospital - Cincinnati
Cincinnati, Ohio, United States, 45219
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Regional Cardiovascular Medical Center
Steubenville, Ohio, United States, 43952
Genesis Healthcare System
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Hillcrest Medical Center
Tulsa, Oklahoma, United States, 74101
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Associated Cardiologists
Harrisburg, Pennsylvania, United States, 17112
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Cardiovascular Associates of Rhode Island
Providence, Rhode Island, United States, 02904
United States, South Carolina
Columbia Cardiology
Columbia, South Carolina, United States, 29204
PeeDee Cardiology Associates
Florence, South Carolina, United States, 29505
United States, South Dakota
Heart Doctors
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Memphis Heart Clinic
Memphis, Tennessee, United States, 37501
United States, Texas
Amarillo Heart Group
Amarillo, Texas, United States, 79106
Texas Cardiac Arrhythmia Research
Austin, Texas, United States, 78705
Heart Hospital of Austin
Austin, Texas, United States, 78756
Cardiology Care Consultants
El Paso, Texas, United States, 79902
Hall Garcia Cardiology
Houston, Texas, United States, 77030
Houston Electrophysiology Associates
Houston, Texas, United States, 77030
Willowbrook Cardiovascular Associates
Houston, Texas, United States, 77030
EP Heart
The Woodlands, Texas, United States, 77384
Tyler Cardiovascular Consultants
Tyler, Texas, United States, 75701
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
Dixie Regional Medical Center
Saint George, Utah, United States, 84790
United States, Virginia
Virginia Heart
Falls Church, Virginia, United States, 22042
Richmond Cardiology Associates
Mechanicsville, Virginia, United States, 23116
United States, Washington
Overlake Medical Center
Bellevue, Washington, United States, 98004
St. Joseph Hospital
Bellingham, Washington, United States, 98225
Swedish Medical Center
Seattle, Washington, United States, 98133
Heart Clinics Northwest
Spokane, Washington, United States, 99204
United States, Wisconsin
Wheaton Franciscan Healthcare
Wauwatosa, Wisconsin, United States, 53226
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Olaf Hedrich, MD Boston Scientific Corporation
  More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00955708     History of Changes
Other Study ID Numbers: LSR of ACUITY Spiral
Study First Received: August 4, 2009
Last Updated: June 5, 2017

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 18, 2017