Longitudinal Surveillance Registry (LSR) of ACUITY Spiral

January 31, 2019 updated by: Boston Scientific Corporation

Condition of Approval Study: Longitudinal Surveillance Registry of the ACUITY Spiral Lead

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1308

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The population will be a broad base representative of those recieving the ACUITY Spiral lead.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Implants
Patients successfully implanted with the ACUITY Spiral Lead
Device: ACUITY Spiral Left Ventricular Lead
The implant of the ACUITY Spiral Lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Chronic Left Ventricular Lead-related Complication Free Rate
Time Frame: Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death).
Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Study Director: Olaf Hedrich, MD, Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2009

Primary Completion (Actual)

February 28, 2018

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

August 4, 2009

First Submitted That Met QC Criteria

August 7, 2009

First Posted (Estimate)

August 10, 2009

Study Record Updates

Last Update Posted (Actual)

May 2, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSR of ACUITY Spiral

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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