Optisure Lead Post Approval Study

Heart Failure Clinical Trial

Official title:

Optisure Lead Post Approval Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02235545
• Other study ID #: 60045220
• Status: Terminated
• Start date: August 2014
• Est. completion date: June 30, 2020

Study information

• Verified date: January 2021
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this post approval study is to characterize the chronic performance of the SJM Optisure family of HV leads in patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1735
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Eligible patients will meet all of the following:

1. Have an approved indication, as per ACC/AHA/HRS/ESC guidelines, for implantation of an ICD or CRT-D system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).

2. Have been implanted with a St. Jude Medical Optisure lead in the last 30 days or are scheduled for an Optisure lead implant.

3. Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

4. Are 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

Patients will be excluded if they meet any of the following:

1. Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by SJM, during the course of this clinical study.

2. Have a life expectancy of less than 5 years due to any condition.

Related Conditions & MeSH terms

• Heart Failure
• Tachycardia
• Tachycardia, Ventricular

Intervention

Device:
• St. Jude Medical Optisure Lead
Patients implanted with St. Jude Medical Optisure Lead

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	QE II Health Sciences	Halifax	Nova Scotia
Canada	Kingston General Hospital	Kingston	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Institut de Cardiologie de Montreal (Montreal Heart Inst.)	Montreal	Quebec
Canada	Rouge Valley Centenary	Scarborough	Ontario
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
Germany	Universitäts-Herzzentrum Freiburg - Bad Krozingen	Bad Krozingen
Japan	Osaka City University Hospital	Abeno-ku	Osaka
Japan	Jichi Medical University Hospital	Shimotsuke-shi	Tochigi-ken
Japan	Tokyo Women's Medical University	Shinjuku-Ku	Kanto
Poland	Mc-Tronik	Lodz
Portugal	Santa Maria Hospital	Lisboa	Lisbon
United States	Presbyterian Heart Group	Albuquerque	New Mexico
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Northside Hospital	Atlanta	Georgia
United States	HeartPlace	Bedford	Texas
United States	Baptist Medical Center Princeton	Birmingham	Alabama
United States	Coney Island Hospital	Brooklyn	New York
United States	Maimonides Medical Center	Brooklyn	New York
United States	Raymond Schaerf, MD	Burbank	California
United States	VA Medical Center Cleveland	Cleveland	Ohio
United States	VA Medical Center Dallas	Dallas	Texas
United States	St. Elizabeth Medical Center - South Unit	Edgewood	Kentucky
United States	Cardiology Care Consultants	El Paso	Texas
United States	Premier Medical Clinics	Flint	Michigan
United States	Parkview Research Center	Fort Wayne	Indiana
United States	Mary Washington Hospital	Fredericksburg	Virginia
United States	The Stern Cardiovascular Foundation	Germantown	Tennessee
United States	Genesys Regional Medical Center	Grand Blanc	Michigan
United States	Cardiovascular Associates of the Delaware Valley	Haddon Heights	New Jersey
United States	High Point Regional Health (formerly Carolina Cardiology Cornerstone)	High Point	North Carolina
United States	Jackson Heart Clinic	Jackson	Mississippi
United States	St. Bernards (formerly Cardiology Associates of Northeast Arkansas)	Jonesboro	Arkansas
United States	Jorge Diaz, M.D. , P.A.	Lake Mary	Florida
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	HealthCare Partners Cardiology	Las Vegas	Nevada
United States	Mass Heart & Rhythm	Leominster	Massachusetts
United States	Cardiovascular Group of Syracuse	Liverpool	New York
United States	Aurora Medical Group	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	CarolinaEast Heart Center	New Bern	North Carolina
United States	Arrhythmia Institute	Newtown	Pennsylvania
United States	Integris Baptist Medical Center	Oklahoma City	Oklahoma
United States	Desert Heart Rhythm Consultants	Palm Springs	California
United States	Phoenix Cardiovascular Research Group	Phoenix	Arizona
United States	Providence Heart and Vascular Institute	Portland	Oregon
United States	Cardiac Rhythm Specialists, Inc.	Reseda	California
United States	Virginia Cardiovascular Specialists	Richmond	Virginia
United States	Rockford Cardiology Associates	Rockford	Illinois
United States	Heart of Dixie Cardiology (formerly Dixie Regional Medical Center - River Road Campus)	Saint George	Utah
United States	Peninsula Cardiology Associates	Salisbury	Maryland
United States	San Diego Heart Rhythm Center (formerly San Diego Heart and Vascular Associates)	San Diego	California
United States	Scott & White Memorial Hospital	Temple	Texas
United States	Northern Michigan Hospital	Traverse City	Michigan
United States	Cardiology Associates of North Mississippi	Tupelo	Mississippi
United States	Lourdes Cardiology Services	Voorhees	New Jersey
United States	Iowa Heart Center	West Des Moines	Iowa
United States	Great Lakes Medical Research, LLC	Willoughby	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  Japan,  Poland,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Optisure Lead Related Adverse Events		Date at which all patients have completed their five year follow-up.
Other	The annual hazard rate of lead electrical dysfunction		Date at which all patients have completed their five year follow-up.
Other	The annual hazard rate of externalized conductors		Date at which all patients have completed their five year follow-up.
Other	The annual hazard rate of other visual lead anomalies by each subcategory		Date at which all patients have completed their five year follow-up.
Other	Prevalence of "other insulation anomalies" in "returned leads		Date at which all patients have completed their five year follow-up.
Other	Time from externalized conductors to electrical dysfunction		Date at which all patients have completed their five year follow-up.
Other	Time from other visual lead anomalies by each subcategory to electrical dysfunction		Date at which all patients have completed their five year follow-up.
Other	Adverse Event rate through 30 days post-intervention for lead (e.g. extraction, abandonment, revision, other)		Date at which all patients have completed their five year follow-up.
Other	Time from externalized conductors to clinical intervention		Date at which all patients have completed their five year follow-up.
Other	Time from other visual lead anomalies by each subcategory to clinical intervention		Date at which all patients have completed their five year follow-up.
Other	Comparison of patients with lead compromise as evidenced by imaging (includes externalized conductors and other visual lead anomalies) to those without lead compromise		Date at which all patients have completed their five year follow-up.
Other	Comparison of patients with electrical dysfunction to those without electrical dysfunction.		Date at which all patients have completed their five year follow-up.
Primary	Freedom from RV Lead Related Complications		Date at which all patients have completed their five year follow-up.
Secondary	Optisure Lead-Related Complication Rates		Date at which all patients have completed their five year follow-up.