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

Status: Terminated
Location: See all (97) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: No
View:

• 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

Locations
United States
Alaska
Providence Alaska Medical Center
Anchorage
Alabama
Birmingham Heart Clinic
Birmingham
University of Alabama at Birmingham
Birmingham
Arkansas
Cardiology Associates of Northeast Arkansas
Jonesboro
Heart Clinic Arkansas
Little Rock
Arizona
Tri-City Cardiology
Mesa
Arizona Arrhythmia Research Center
Scottsdale
Pima Heart Physicians
Tucson
California
Comprehensive Cardiovascular Medical Group
Bakersfield
Belott Cardiology
El Cajon
Fullerton Cardiovascular
Fullerton
Cardiac Device Rhythm Specialists
Los Angeles
Cedars - Sinai Medical Center
Los Angeles
Memorial Hospital
Modesto
Cardiac Rhythm Specialists, Inc.
Northridge
Cardiovascular Consultants
Oakland
Orange County Heart Institute
Orange
Eisenhower Medical Center
Rancho Mirage
Truong D Duong Cardiac Electrophysiology
Riverside
Regional Cardiology Associates
Sacramento
Sansum Clinic
Santa Barbara
Florida
Bethesda Memorial Hospital
Atlantis
Heart and Vascular Institute of Florida
Clearwater
Miami International Cardiology Consultants
Miami
Complete Cardiology Care
New Smyrna Beach
Orlando Regional Hospital
Orlando
Tallahassee Memorial Hospital
Tallahassee
West Coast Arrhythmia Center
Trinity
Georgia
Phoebe Putney Memorial Hospital
Albany
Medical College of Georgia Health
Augusta
Northeast Georgia Heart Center
Gainesville
Georgia Arrhythmia Consultants
Macon
Idaho
St Lukes Idaho Cardiology Assoc.
Boise
Illinois
Alexian Brothers Medical Center
Elk Grove Village
Heart Care Research Foundation
Mokena
Indiana
Northern Indiana Research Alliance
Fort Wayne
St. Mary Medical Center - Indiana
Hobart
Kansas
Via-Christi Regional Medical Center
Wichita
Kentucky
Southern Kentucky Heart Institute
Bowling Green
Central Baptist Hospital
Lexington
St. Joseph Hospital
Lexington
Commonwealth Cardiology
Louisville
Massachusetts
Massachusetts General Hospital
Boston
Steward St. Elizabeth's Medical Center
Boston
Maryland
Baltimore Heart Association
Randallstown
Michigan
St. Joseph Mercy Hospital
Ann Arbor
Heart Care
Detroit
Cardiology Consultants of East Michigan
Flint
West Michigan Heart
Grand Rapids
Providence Hospital
Southfield
Minnesota
St. Mary's Duluth Clinic
Duluth
Missouri
Missouri Heart Center
Columbia
Research Medical Center
Kansas City
Metro Heart Group South County
Saint Louis
Cox Health
Springfield
North Carolina
Mid-Carolina Cardiology
Charlotte
Pinehurst Cardiology Consultants
Pinehurst
Nebraska
Nebraska Heart Institute
Lincoln
New Jersey
New Jersey Cardiology Associates
West Orange
New York
Capital Cardiology Associates
Albany
Island Cardiac Specialists
Garden City
Columbia University Medical Center
New York
Ohio
Christ Hospital - Cincinnati
Cincinnati
Ohio State University Medical Center
Columbus
Riverside Methodist Hospital
Columbus
Regional Cardiovascular Medical Center
Steubenville
Genesis Healthcare System
Zanesville
Oklahoma
Hillcrest Medical Center
Tulsa
Pennsylvania
Abington Memorial Hospital
Abington
Associated Cardiologists
Harrisburg
Albert Einstein Medical Center
Philadelphia
Drexel University College of Medicine
Philadelphia
Hospital of the University of Pennsylvania
Philadelphia
Lankenau Hospital
Wynnewood
Rhode Island
Cardiovascular Associates of Rhode Island
Providence
South Carolina
Columbia Cardiology
Columbia
PeeDee Cardiology Associates
Florence
South Dakota
Heart Doctors
Rapid City
Tennessee
Memphis Heart Clinic
Memphis
Texas
Amarillo Heart Group
Amarillo
Heart Hospital of Austin
Austin
Texas Cardiac Arrhythmia Research
Austin
Cardiology Care Consultants
El Paso
Hall Garcia Cardiology
Houston
Houston Electrophysiology Associates
Houston
Willowbrook Cardiovascular Associates
Houston
EP Heart
The Woodlands
Tyler Cardiovascular Consultants
Tyler
Utah
Intermountain Medical Center
Murray
Dixie Regional Medical Center
Saint George
Virginia
Virginia Heart
Falls Church
Richmond Cardiology Associates
Mechanicsville
Washington
Overlake Medical Center
Bellevue
St. Joseph Hospital
Bellingham
Swedish Medical Center
Seattle
Heart Clinics Northwest
Spokane
Wisconsin
Wheaton Franciscan Healthcare
Wauwatosa
Time Frame
Start Date: August 4, 2009
Completion Date: February 28, 2018
Participants
Target number of participants: 1308
Treatments
Implants
Patients successfully implanted with the ACUITY Spiral Lead
Related Therapeutic Areas
Sponsors
Leads: Boston Scientific Corporation

This content was sourced from clinicaltrials.gov

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