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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 4, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings