Optisure Lead Post Approval Study

Terminated

• Conditions: Heart Failure; Tachycardia, Ventricular

• Registration Number: NCT02235545
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-09-07
• Study First Submitted QC: 2014-09-09
• Study First Posted: 2014-09-10
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1735

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from RV Lead Related Complications	Date at which all patients have completed their five year follow-up.

Secondary Outcome Measures

Name	Time	Method
Optisure Lead-Related Complication Rates	Date at which all patients have completed their five year follow-up.

Trial Locations

Locations (60)

Baptist Medical Center Princeton; 🇺🇸 Birmingham, Alabama, United States

Phoenix Cardiovascular Research Group; 🇺🇸 Phoenix, Arizona, United States

St. Bernards (formerly Cardiology Associates of Northeast Arkansas); 🇺🇸 Jonesboro, Arkansas, United States

Raymond Schaerf, MD; 🇺🇸 Burbank, California, United States

Desert Heart Rhythm Consultants; 🇺🇸 Palm Springs, California, United States

Cardiac Rhythm Specialists, Inc.; 🇺🇸 Reseda, California, United States

San Diego Heart Rhythm Center (formerly San Diego Heart and Vascular Associates); 🇺🇸 San Diego, California, United States

Jorge Diaz, M.D. , P.A.; 🇺🇸 Lake Mary, Florida, United States

Northside Hospital; 🇺🇸 Atlanta, Georgia, United States

Rockford Cardiology Associates; 🇺🇸 Rockford, Illinois, United States

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