Clinical trial NCT00955708: Longitudinal Surveillance Registry (LSR) of ACUITY Spiral
Official title: Condition of Approval Study: Longitudinal Surveillance Registry of the ACUITY Spiral Lead
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2009-08-10
Enrollment: 1308
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will be a broad base representative of those recieving the ACUITY Spiral lead.

Brief 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 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

Primary outcomes:
measure: Chronic Left Ventricular Lead-related Complication Free Rate
timeFrame: Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death).
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Heart Clinic
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Anchorage
country: United States
facility: Providence Alaska Medical Center
state: Alaska
city: Mesa
country: United States
facility: Tri-City Cardiology
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Arrhythmia Research Center
state: Arizona
city: Tucson
country: United States
facility: Pima Heart Physicians
state: Arizona
city: Jonesboro
country: United States
facility: Cardiology Associates of Northeast Arkansas
state: Arkansas
city: Little Rock
country: United States
facility: Heart Clinic Arkansas
state: Arkansas
city: Bakersfield
country: United States
facility: Comprehensive Cardiovascular Medical Group
state: California
city: El Cajon
country: United States
facility: Belott Cardiology
state: California
city: Fullerton
country: United States
facility: Fullerton Cardiovascular
state: California
city: Los Angeles
country: United States
facility: Cardiac Device Rhythm Specialists
state: California
city: Los Angeles
country: United States
facility: Cedars - Sinai Medical Center
state: California
city: Modesto
country: United States
facility: Memorial Hospital
state: California
city: Northridge
country: United States
facility: Cardiac Rhythm Specialists, Inc.
state: California
city: Oakland
country: United States
facility: Cardiovascular Consultants
state: California
city: Orange
country: United States
facility: Orange County Heart Institute
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: Riverside
country: United States
facility: Truong D Duong Cardiac Electrophysiology
state: California
city: Sacramento
country: United States
facility: Regional Cardiology Associates
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Atlantis
country: United States
facility: Bethesda Memorial Hospital
state: Florida
city: Clearwater
country: United States
facility: Heart and Vascular Institute of Florida
state: Florida
city: Miami
country: United States
facility: Miami International Cardiology Consultants
state: Florida
city: New Smyrna Beach
country: United States
facility: Complete Cardiology Care
state: Florida
city: Orlando
country: United States
facility: Orlando Regional Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Trinity
country: United States
facility: West Coast Arrhythmia Center
state: Florida
city: Albany
country: United States
facility: Phoebe Putney Memorial Hospital
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia Health
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Heart Center
state: Georgia
city: Macon
country: United States
facility: Georgia Arrhythmia Consultants
state: Georgia
city: Boise
country: United States
facility: St Lukes Idaho Cardiology Assoc.
state: Idaho
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Mokena
country: United States
facility: Heart Care Research Foundation
state: Illinois
city: Fort Wayne
country: United States
facility: Northern Indiana Research Alliance
state: Indiana
city: Hobart
country: United States
facility: St. Mary Medical Center - Indiana
state: Indiana
city: Wichita
country: United States
facility: Via-Christi Regional Medical Center
state: Kansas
city: Bowling Green
country: United States
facility: Southern Kentucky Heart Institute
state: Kentucky
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Lexington
country: United States
facility: St. Joseph Hospital
state: Kentucky
city: Louisville
country: United States
facility: Commonwealth Cardiology
state: Kentucky
city: Randallstown
country: United States
facility: Baltimore Heart Association
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Steward St. Elizabeth's Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Detroit
country: United States
facility: Heart Care
state: Michigan
city: Flint
country: United States
facility: Cardiology Consultants of East Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: West Michigan Heart
state: Michigan
city: Southfield
country: United States
facility: Providence Hospital
state: Michigan
city: Duluth
country: United States
facility: St. Mary's Duluth Clinic
state: Minnesota
city: Columbia
country: United States
facility: Missouri Heart Center
state: Missouri
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Metro Heart Group South County
state: Missouri
city: Springfield
country: United States
facility: Cox Health
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: West Orange
country: United States
facility: New Jersey Cardiology Associates
state: New Jersey
city: Albany
country: United States
facility: Capital Cardiology Associates
state: New York
city: Garden City
country: United States
facility: Island Cardiac Specialists
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Charlotte
country: United States
facility: Mid-Carolina Cardiology
state: North Carolina
city: Pinehurst
country: United States
facility: Pinehurst Cardiology Consultants
state: North Carolina
city: Cincinnati
country: United States
facility: Christ Hospital - Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Steubenville
country: United States
facility: Regional Cardiovascular Medical Center
state: Ohio
city: Zanesville
country: United States
facility: Genesis Healthcare System
state: Ohio
city: Tulsa
country: United States
facility: Hillcrest Medical Center
state: Oklahoma
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Harrisburg
country: United States
facility: Associated Cardiologists
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Cardiovascular Associates of Rhode Island
state: Rhode Island
city: Columbia
country: United States
facility: Columbia Cardiology
state: South Carolina
city: Florence
country: United States
facility: PeeDee Cardiology Associates
state: South Carolina
city: Rapid City
country: United States
facility: Heart Doctors
state: South Dakota
city: Memphis
country: United States
facility: Memphis Heart Clinic
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Heart Group
state: Texas
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research
state: Texas
city: Austin
country: United States
facility: Heart Hospital of Austin
state: Texas
city: El Paso
country: United States
facility: Cardiology Care Consultants
state: Texas
city: Houston
country: United States
facility: Hall Garcia Cardiology
state: Texas
city: Houston
country: United States
facility: Houston Electrophysiology Associates
state: Texas
city: Houston
country: United States
facility: Willowbrook Cardiovascular Associates
state: Texas
city: The Woodlands
country: United States
facility: EP Heart
state: Texas
city: Tyler
country: United States
facility: Tyler Cardiovascular Consultants
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Saint George
country: United States
facility: Dixie Regional Medical Center
state: Utah
city: Falls Church
country: United States
facility: Virginia Heart
state: Virginia
city: Mechanicsville
country: United States
facility: Richmond Cardiology Associates
state: Virginia
city: Bellevue
country: United States
facility: Overlake Medical Center
state: Washington
city: Bellingham
country: United States
facility: St. Joseph Hospital
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Spokane
country: United States
facility: Heart Clinics Northwest
state: Washington
city: Wauwatosa
country: United States
facility: Wheaton Franciscan Healthcare
state: Wisconsin
Study officials:
affiliation: Boston Scientific Corporation
name: Olaf Hedrich, MD
role: STUDY_DIRECTOR
References: