Longitudinal Surveillance Registry (LSR) of ACUITY Spiral

NCT ID: NCT00955708

Last Updated: 2019-05-02

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1308 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-04

Study Completion Date

2018-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Implants

Patients successfully implanted with the ACUITY Spiral Lead

ACUITY Spiral Left Ventricular Lead

Intervention Type DEVICE

The implant of the ACUITY Spiral Lead

Interventions

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ACUITY Spiral Left Ventricular Lead

The implant of the ACUITY Spiral Lead

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olaf Hedrich, MD

Role: STUDY_DIRECTOR

Boston Scientific Corporation

Locations

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Birmingham Heart Clinic

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Providence Alaska Medical Center

Anchorage, Alaska, United States

Site Status

Tri-City Cardiology

Mesa, Arizona, United States

Site Status

Arizona Arrhythmia Research Center

Scottsdale, Arizona, United States

Site Status

Pima Heart Physicians

Tucson, Arizona, United States

Site Status

Cardiology Associates of Northeast Arkansas

Jonesboro, Arkansas, United States

Site Status

Heart Clinic Arkansas

Little Rock, Arkansas, United States

Site Status

Comprehensive Cardiovascular Medical Group

Bakersfield, California, United States

Site Status

Belott Cardiology

El Cajon, California, United States

Site Status

Fullerton Cardiovascular

Fullerton, California, United States

Site Status

Cardiac Device Rhythm Specialists

Los Angeles, California, United States

Site Status

Cedars - Sinai Medical Center

Los Angeles, California, United States

Site Status

Memorial Hospital

Modesto, California, United States

Site Status

Cardiac Rhythm Specialists, Inc.

Northridge, California, United States

Site Status

Cardiovascular Consultants

Oakland, California, United States

Site Status

Orange County Heart Institute

Orange, California, United States

Site Status

Eisenhower Medical Center

Rancho Mirage, California, United States

Site Status

Truong D Duong Cardiac Electrophysiology

Riverside, California, United States

Site Status

Regional Cardiology Associates

Sacramento, California, United States

Site Status

Sansum Clinic

Santa Barbara, California, United States

Site Status

Bethesda Memorial Hospital

Atlantis, Florida, United States

Site Status

Heart and Vascular Institute of Florida

Clearwater, Florida, United States

Site Status

Miami International Cardiology Consultants

Miami, Florida, United States

Site Status

Complete Cardiology Care

New Smyrna Beach, Florida, United States

Site Status

Orlando Regional Hospital

Orlando, Florida, United States

Site Status

Tallahassee Memorial Hospital

Tallahassee, Florida, United States

Site Status

West Coast Arrhythmia Center

Trinity, Florida, United States

Site Status

Phoebe Putney Memorial Hospital

Albany, Georgia, United States

Site Status

Medical College of Georgia Health

Augusta, Georgia, United States

Site Status

Northeast Georgia Heart Center

Gainesville, Georgia, United States

Site Status

Georgia Arrhythmia Consultants

Macon, Georgia, United States

Site Status

St Lukes Idaho Cardiology Assoc.

Boise, Idaho, United States

Site Status

Alexian Brothers Medical Center

Elk Grove Village, Illinois, United States

Site Status

Heart Care Research Foundation

Mokena, Illinois, United States

Site Status

Northern Indiana Research Alliance

Fort Wayne, Indiana, United States

Site Status

St. Mary Medical Center - Indiana

Hobart, Indiana, United States

Site Status

Via-Christi Regional Medical Center

Wichita, Kansas, United States

Site Status

Southern Kentucky Heart Institute

Bowling Green, Kentucky, United States

Site Status

Central Baptist Hospital

Lexington, Kentucky, United States

Site Status

St. Joseph Hospital

Lexington, Kentucky, United States

Site Status

Commonwealth Cardiology

Louisville, Kentucky, United States

Site Status

Baltimore Heart Association

Randallstown, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Steward St. Elizabeth's Medical Center

Boston, Massachusetts, United States

Site Status

St. Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Site Status

Heart Care

Detroit, Michigan, United States

Site Status

Cardiology Consultants of East Michigan

Flint, Michigan, United States

Site Status

West Michigan Heart

Grand Rapids, Michigan, United States

Site Status

Providence Hospital

Southfield, Michigan, United States

Site Status

St. Mary's Duluth Clinic

Duluth, Minnesota, United States

Site Status

Missouri Heart Center

Columbia, Missouri, United States

Site Status

Research Medical Center

Kansas City, Missouri, United States

Site Status

Cox Health

Springfield, Missouri, United States

Site Status

Metro Heart Group South County

St Louis, Missouri, United States

Site Status

Nebraska Heart Institute

Lincoln, Nebraska, United States

Site Status

New Jersey Cardiology Associates

West Orange, New Jersey, United States

Site Status

Capital Cardiology Associates

Albany, New York, United States

Site Status

Island Cardiac Specialists

Garden City, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Mid-Carolina Cardiology

Charlotte, North Carolina, United States

Site Status

Pinehurst Cardiology Consultants

Pinehurst, North Carolina, United States

Site Status

Christ Hospital - Cincinnati

Cincinnati, Ohio, United States

Site Status

Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status

Regional Cardiovascular Medical Center

Steubenville, Ohio, United States

Site Status

Genesis Healthcare System

Zanesville, Ohio, United States

Site Status

Hillcrest Medical Center

Tulsa, Oklahoma, United States

Site Status

Abington Memorial Hospital

Abington, Pennsylvania, United States

Site Status

Associated Cardiologists

Harrisburg, Pennsylvania, United States

Site Status

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Lankenau Hospital

Wynnewood, Pennsylvania, United States

Site Status

Cardiovascular Associates of Rhode Island

Providence, Rhode Island, United States

Site Status

Columbia Cardiology

Columbia, South Carolina, United States

Site Status

PeeDee Cardiology Associates

Florence, South Carolina, United States

Site Status

Heart Doctors

Rapid City, South Dakota, United States

Site Status

Memphis Heart Clinic

Memphis, Tennessee, United States

Site Status

Amarillo Heart Group

Amarillo, Texas, United States

Site Status

Texas Cardiac Arrhythmia Research

Austin, Texas, United States

Site Status

Heart Hospital of Austin

Austin, Texas, United States

Site Status

Cardiology Care Consultants

El Paso, Texas, United States

Site Status

Hall Garcia Cardiology

Houston, Texas, United States

Site Status

Houston Electrophysiology Associates

Houston, Texas, United States

Site Status

Willowbrook Cardiovascular Associates

Houston, Texas, United States

Site Status

EP Heart

The Woodlands, Texas, United States

Site Status

Tyler Cardiovascular Consultants

Tyler, Texas, United States

Site Status

Intermountain Medical Center

Murray, Utah, United States

Site Status

Dixie Regional Medical Center

St. George, Utah, United States

Site Status

Virginia Heart

Falls Church, Virginia, United States

Site Status

Richmond Cardiology Associates

Mechanicsville, Virginia, United States

Site Status

Overlake Medical Center

Bellevue, Washington, United States

Site Status

St. Joseph Hospital

Bellingham, Washington, United States

Site Status

Swedish Medical Center

Seattle, Washington, United States

Site Status

Heart Clinics Northwest

Spokane, Washington, United States

Site Status

Wheaton Franciscan Healthcare

Wauwatosa, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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LSR of ACUITY Spiral

Identifier Type: -

Identifier Source: org_study_id

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