Trial record 1 of 1 for:    LSR of Acuity - Longitudinal Surveillance Registry of the Acuity™ Spiral Lead
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Longitudinal Surveillance Registry (LSR) of ACUITY Spiral

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00955708
First received: August 4, 2009
Last updated: July 14, 2014
Last verified: July 2014
  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 Phase
Heart Failure
Device: ACUITY Spiral Left Ventricular Lead
Phase 4

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1700
Study Start Date: August 2009
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2021 (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

Genders Eligible for Study:   Both
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

Contacts
Contact: Jill Leigh jill.leigh@bsci.com
Contact: Clinical Study Helpdesk 1-800-CARDIAC cshd@bsci.com

  Hide Study Locations
Locations
United States, Alabama
Birmingham Heart Clinic Recruiting
Birmingham, Alabama, United States, 35235
Contact: Michael Bailey, MD         
Principal Investigator: Michael Bailey         
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Harish Doppalapudi         
Principal Investigator: Harish Doppalapudi         
United States, Alaska
Providence Alaska Medical Center Recruiting
Anchorage, Alaska, United States, 99508
Contact: Steve Compton         
Principal Investigator: Steve Compton         
United States, Arizona
Tri-City Cardiology Active, not recruiting
Mesa, Arizona, United States, 85206
Arizona Arrhythmia Research Center Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Vijendra Swarup, MD         
Principal Investigator: Vijendra Swarup         
Pima Heart Physicians Completed
Tucson, Arizona, United States, 85712
United States, Arkansas
Cardiology Associates of Northeast Arkansas Recruiting
Jonesboro, Arkansas, United States, 72401
Contact: Devi Nair, MD         
Principal Investigator: Devi Nair         
Heart Clinic Arkansas Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Van DeBruyn         
Principal Investigator: Van DeBruyn         
United States, California
Comprehensive Cardiovascular Medical Group Recruiting
Bakersfield, California, United States, 93309
Contact: Viral Mehta         
Principal Investigator: Viral Mehta         
Belott Cardiology Recruiting
El Cajon, California, United States, 92021
Contact: Peter Belott, MD         
Principal Investigator: Peter Belott         
Fullerton Cardiovascular Completed
Fullerton, California, United States, 92835
Cardiac Device Rhythm Specialists Recruiting
Los Angeles, California, United States, 90033
Contact: Prash Jayaraj         
Principal Investigator: Prash Jayaraj         
Cedars - Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Donna Gallik         
Principal Investigator: Donna Gallik         
Memorial Hospital Completed
Modesto, California, United States, 95355
Cardiac Rhythm Specialists, Inc. Recruiting
Northridge, California, United States, 91325
Contact: Leo Polosajian         
Principal Investigator: Leo Polosajian         
Cardiovascular Consultants Recruiting
Oakland, California, United States, 94609
Contact: Steven Kang         
Principal Investigator: Steven Kang         
Orange County Heart Institute Recruiting
Orange, California, United States, 92868
Contact: Jay Lee         
Principal Investigator: Jay Lee         
Eisenhower Medical Center Recruiting
Rancho Mirage, California, United States, 92270
Contact: Leon Feldman         
Principal Investigator: Leon Feldman         
Truong D Duong Cardiac Electrophysiology Completed
Riverside, California, United States, 92501
Regional Cardiology Associates Recruiting
Sacramento, California, United States, 95819
Contact: Gearoid O'Neill         
Principal Investigator: Gearoid O'Neill         
Sansum Clinic Completed
Santa Barbara, California, United States, 93102
United States, Florida
Bethesda Memorial Hospital Recruiting
Atlantis, Florida, United States, 33462
Contact: Faren Angella, MD         
Principal Investigator: Faren Angella         
Heart and Vascular Institute of Florida Recruiting
Clearwater, Florida, United States, 33756
Contact: Ronald Walsh         
Principal Investigator: Ronald Walsh         
Miami International Cardiology Consultants Completed
Miami, Florida, United States, 33137
Complete Cardiology Care Recruiting
New Smyrna Beach, Florida, United States, 32168
Contact: Huijian Wang         
Principal Investigator: Huijian Wang         
Orlando Regional Hospital Completed
Orlando, Florida, United States, 32806
Tallahassee Memorial Hospital Recruiting
Tallahassee, Florida, United States, 32308
Contact: Farhat Khairallah         
Principal Investigator: Farhat Khairallah         
West Coast Arrhythmia Center Recruiting
Trinity, Florida, United States, 34655
Contact: Kenneth Yamamura         
Principal Investigator: Kenneth Yamamura         
United States, Georgia
Phoebe Putney Memorial Hospital Recruiting
Albany, Georgia, United States, 31701
Contact: Kamil Hanna         
Principal Investigator: Kamil Hanna         
Medical College of Georgia Health Completed
Augusta, Georgia, United States, 30912
Northeast Georgia Heart Center Recruiting
Gainesville, Georgia, United States, 30501
Contact: Joon Ahn         
Principal Investigator: Joon Ahn         
Georgia Arrhythmia Consultants Completed
Macon, Georgia, United States, 31201
United States, Idaho
St Lukes Idaho Cardiology Assoc. Completed
Boise, Idaho, United States, 83712
United States, Illinois
Alexian Brothers Medical Center Recruiting
Elk Grove Village, Illinois, United States, 60007
Contact: Mohammed Khan, MD         
Principal Investigator: Mohammed Khan         
Heart Care Research Foundation Completed
Mokena, Illinois, United States, 60448
United States, Indiana
Northern Indiana Research Alliance Recruiting
Ft. Wayne, Indiana, United States, 46804
Contact: Sree Karanam         
Principal Investigator: Sree Karanam         
St. Mary Medical Center - Indiana Recruiting
Hobart, Indiana, United States, 46342
Contact: Raghuram Dasari         
Principal Investigator: Raghuram Dasari         
United States, Kansas
Via-Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Ravi Bajaj         
Principal Investigator: Ravi Bajaj         
United States, Kentucky
Southern Kentucky Heart Institute Recruiting
Bowling Green, Kentucky, United States, 42101
Contact: Frank Schwender         
Principal Investigator: Frank Schwender         
Central Baptist Hospital Recruiting
Lexington, Kentucky, United States, 40503
Contact: Aaron Hesselson         
Principal Investigator: Aaron Hesselson         
St. Joseph Hospital Recruiting
Lexington, Kentucky, United States, 40504
Contact: William Schoen         
Principal Investigator: William Schoen         
Commonwealth Cardiology Completed
Louisville, Kentucky, United States, 40202
United States, Maryland
Baltimore Heart Association Recruiting
Randallstown, Maryland, United States, 21133
Contact: Ajay Soodan, MD         
Principal Investigator: Ajay Soodan         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Theofanie Mela         
Principal Investigator: Theofanie Mela         
Steward St. Elizabeth's Medical Center Recruiting
Boston, Massachusetts, United States, 02135
Contact: Michael Orlov         
Principal Investigator: Michael Orlov         
United States, Michigan
St. Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Radmira Greenstein         
Principal Investigator: Radmira Greenstein         
Bay Regional Medical Center Withdrawn
Bay City, Michigan, United States, 48708
Heart Care Completed
Detroit, Michigan, United States, 48201
Cardiology Consultants of East Michigan Recruiting
Flint, Michigan, United States, 48507
Contact: Abdul Alawwa         
Principal Investigator: Abdul Alawwa         
West Michigan Heart Recruiting
Grand Rapids, Michigan, United States, 49301
Contact: Andre Gauri         
Principal Investigator: Andre Gauri         
Providence Hospital Recruiting
Southfield, Michigan, United States, 48075
Contact: Christian Machado         
Principal Investigator: Christian Machado         
United States, Minnesota
St. Mary's Duluth Clinic Recruiting
Duluth, Minnesota, United States, 55805
Contact: Michael Mollerus         
Principal Investigator: Michael Mollerus         
United States, Missouri
Missouri Heart Center Recruiting
Columbia, Missouri, United States, 65201
Contact: Sanjeev Ravipudi         
Principal Investigator: Sanjeev Ravipudi         
Research Medical Center Recruiting
Kansas City, Missouri, United States, 64114
Contact: John Lee         
Principal Investigator: John Lee         
Cox Health Completed
Springfield, Missouri, United States, 65807
Metro Heart Group South County Completed
St. Louis, Missouri, United States, 63128
United States, Nebraska
Nebraska Heart Institute Recruiting
Lincoln, Nebraska, United States, 68526
Contact: Peter Gallagher         
Principal Investigator: Peter Gallagher         
United States, New Jersey
New Jersey Cardiology Associates Recruiting
West Orange, New Jersey, United States, 07052
Contact: Marc Roelke         
Principal Investigator: Marc Roelke         
United States, New York
Capital Cardiology Associates Recruiting
Albany, New York, United States, 12208
Contact: Ian Santoro         
Principal Investigator: Ian Santoro         
Island Cardiac Specialists Recruiting
Garden City, New York, United States, 11530
Contact: Jeffrey Snow         
Principal Investigator: Jeffrey Snow         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Jose Dizon         
Principal Investigator: Jose Dizon         
United States, North Carolina
Mid-Carolina Cardiology Recruiting
Charlotte, North Carolina, United States, 28204
Contact: J Bailey         
Principal Investigator: J Bailey         
Pinehurst Cardiology Consultants Recruiting
Pinehurst, North Carolina, United States, 28374
Contact: Mark Landers         
Principal Investigator: Mark Landers         
United States, Ohio
Christ Hospital - Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: E J Schloss         
Principal Investigator: E J Schloss         
Ohio State University Medical Center Completed
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: Gregory Kidwell         
Principal Investigator: Gregory Kidwell         
Regional Cardiovascular Medical Center Recruiting
Steubenville, Ohio, United States, 43952
Contact: Maninder Bedi         
Principal Investigator: Maninder Bedi         
Genesis Healthcare System Recruiting
Zanesville, Ohio, United States, 43701
Contact: Magdy Migeed         
Principal Investigator: Magdy Migeed         
United States, Oklahoma
Hillcrest Medical Center Completed
Tulsa, Oklahoma, United States, 74101
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Charles Gottlieb, MD         
Principal Investigator: Charles Gottlieb         
Associated Cardiologists Completed
Harrisburg, Pennsylvania, United States, 17112
Albert Einstein Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Sumeet Mainigi, MD         
Principal Investigator: Sumeet Mainigi         
Drexel University College of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Steven Kutalek         
Principal Investigator: Steven Kutalek         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Fermin Garcia         
Principal Investigator: Fermin Garcia         
Lankenau Hospital Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Douglas Esberg         
Principal Investigator: Douglas Esberg         
United States, Rhode Island
Cardiovascular Associates of Rhode Island Recruiting
Providence, Rhode Island, United States, 02904
Contact: Michael Hyder         
Principal Investigator: Michael Hyder         
United States, South Carolina
Columbia Cardiology Recruiting
Columbia, South Carolina, United States, 29204
Contact: Robert Malanuk         
Principal Investigator: Robert Malanuk         
PeeDee Cardiology Associates Recruiting
Florence, South Carolina, United States, 29505
Contact: Rajesh Malik         
Principal Investigator: Rajesh Malik         
United States, South Dakota
Heart Doctors Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Jose Teixeira         
Principal Investigator: Jose Teixeira         
United States, Tennessee
Memphis Heart Clinic Completed
Memphis, Tennessee, United States, 37501
United States, Texas
Amarillo Heart Group Completed
Amarillo, Texas, United States, 79106
Texas Cardiac Arrhythmia Research Recruiting
Austin, Texas, United States, 78705
Contact: Javier Sanchez         
Principal Investigator: Javier Sanchez         
Heart Hospital of Austin Recruiting
Austin, Texas, United States, 78756
Contact: Jeffrey Whitehill, MD         
Principal Investigator: Jeffrey Whitehill         
Cardiology Care Consultants Recruiting
El Paso, Texas, United States, 79902
Contact: Juan Taveras         
Principal Investigator: Juan Taveras         
Hall Garcia Cardiology Completed
Houston, Texas, United States, 77030
Houston Electrophysiology Associates Completed
Houston, Texas, United States, 77030
Willowbrook Cardiovascular Associates Completed
Houston, Texas, United States, 77030
EP Heart Recruiting
The Woodlands, Texas, United States, 77384
Contact: Ramesh Hariharan         
Principal Investigator: Ramesh Hariharan         
Tyler Cardiovascular Consultants Recruiting
Tyler, Texas, United States, 75701
Contact: David Dick         
Principal Investigator: David Dick         
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
Contact: Jeffrey Osborn         
Dixie Regional Medical Center Completed
St. George, Utah, United States, 84790
United States, Virginia
Virginia Heart Recruiting
Falls Church, Virginia, United States, 22042
Contact: Walter Atiga, MD         
Principal Investigator: Walter Atiga         
Richmond Cardiology Associates Recruiting
Mechanicsville, Virginia, United States, 23116
Contact: Harpreet Grewal         
Principal Investigator: Harpreet Grewal         
United States, Washington
Overlake Medical Center Recruiting
Bellevue, Washington, United States, 98004
Contact: Jeffrey Fowler         
Principal Investigator: Jeffrey Fowler         
St. Joseph Hospital Recruiting
Bellingham, Washington, United States, 98225
Contact: M MacGregor         
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98133
Contact: Darryl Wells         
Principal Investigator: Darryl Wells         
Heart Clinics Northwest Recruiting
Spokane, Washington, United States, 99204
Contact: Timothy Lessmeier         
Principal Investigator: Timothy Lessmeier         
United States, Wisconsin
Wheaton Franciscan Healthcare Recruiting
Wauwatosa, Wisconsin, United States, 53226
Contact: Margot Vloka         
Principal Investigator: Margot Vloka         
Puerto Rico
VA Caribbean Health Care System Withdrawn
San Juan, Puerto Rico, 00921
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Arjun Sharma, MD Boston Scientific Corporation
  More Information

No publications provided

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: July 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014