Optisure Lead Post Approval Study
Sponsor
Abbott Medical Devices (Industry)
Overall Status
Terminated
CT.gov ID
NCT02235545
Collaborator
(none)
1,735
60
71
28.9
0.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
1735 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Optisure Lead Post Approval Study
Actual Study Start Date
:
Aug 1, 2014
Actual Primary Completion Date
:
Jun 30, 2020
Actual Study Completion Date
:
Jun 30, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| St. Jude Medical Optisure Lead Patients implanted with St. Jude Medical Optisure Lead |
Device: St. Jude Medical Optisure Lead
Patients implanted with St. Jude Medical Optisure Lead
|
Outcome Measures
Primary Outcome Measures
- Freedom from RV Lead Related Complications [Date at which all patients have completed their five year follow-up.]
Secondary Outcome Measures
- Optisure Lead-Related Complication Rates [Date at which all patients have completed their five year follow-up.]
Other Outcome Measures
- Optisure Lead Related Adverse Events [Date at which all patients have completed their five year follow-up.]
- The annual hazard rate of lead electrical dysfunction [Date at which all patients have completed their five year follow-up.]
- The annual hazard rate of externalized conductors [Date at which all patients have completed their five year follow-up.]
- The annual hazard rate of other visual lead anomalies by each subcategory [Date at which all patients have completed their five year follow-up.]
- Prevalence of "other insulation anomalies" in "returned leads [Date at which all patients have completed their five year follow-up.]
- Time from externalized conductors to electrical dysfunction [Date at which all patients have completed their five year follow-up.]
- Time from other visual lead anomalies by each subcategory to electrical dysfunction [Date at which all patients have completed their five year follow-up.]
- 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.]
- Time from externalized conductors to clinical intervention [Date at which all patients have completed their five year follow-up.]
- Time from other visual lead anomalies by each subcategory to clinical intervention [Date at which all patients have completed their five year follow-up.]
- 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.]
- Comparison of patients with electrical dysfunction to those without electrical dysfunction. [Date at which all patients have completed their five year follow-up.]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Eligible patients will meet all of the following:
-
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).
-
Have been implanted with a St. Jude Medical Optisure lead in the last 30 days or are scheduled for an Optisure lead implant.
-
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.
-
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:
-
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.
-
Have a life expectancy of less than 5 years due to any condition.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baptist Medical Center Princeton | Birmingham | Alabama | United States | 35211 |
| 2 | Phoenix Cardiovascular Research Group | Phoenix | Arizona | United States | 85018 |
| 3 | St. Bernards (formerly Cardiology Associates of Northeast Arkansas) | Jonesboro | Arkansas | United States | 72401 |
| 4 | Raymond Schaerf, MD | Burbank | California | United States | 91505 |
| 5 | Desert Heart Rhythm Consultants | Palm Springs | California | United States | 92262 |
| 6 | Cardiac Rhythm Specialists, Inc. | Reseda | California | United States | 91335 |
| 7 | San Diego Heart Rhythm Center (formerly San Diego Heart and Vascular Associates) | San Diego | California | United States | 92103 |
| 8 | Jorge Diaz, M.D. , P.A. | Lake Mary | Florida | United States | 32746 |
| 9 | Northside Hospital | Atlanta | Georgia | United States | 30342 |
| 10 | Rockford Cardiology Associates | Rockford | Illinois | United States | 61107 |
| 11 | Parkview Research Center | Fort Wayne | Indiana | United States | 46845 |
| 12 | Iowa Heart Center | West Des Moines | Iowa | United States | 50266 |
| 13 | St. Elizabeth Medical Center - South Unit | Edgewood | Kentucky | United States | 41017 |
| 14 | Peninsula Cardiology Associates | Salisbury | Maryland | United States | 21804 |
| 15 | Mass Heart & Rhythm | Leominster | Massachusetts | United States | 01453 |
| 16 | Premier Medical Clinics | Flint | Michigan | United States | 48532 |
| 17 | Genesys Regional Medical Center | Grand Blanc | Michigan | United States | 48439 |
| 18 | Northern Michigan Hospital | Traverse City | Michigan | United States | 49684 |
| 19 | Minneapolis Heart Institute | Minneapolis | Minnesota | United States | 55407 |
| 20 | Jackson Heart Clinic | Jackson | Mississippi | United States | 39216 |
| 21 | Cardiology Associates of North Mississippi | Tupelo | Mississippi | United States | 38801 |
| 22 | HealthCare Partners Cardiology | Las Vegas | Nevada | United States | 89109 |
| 23 | Cardiovascular Associates of the Delaware Valley | Haddon Heights | New Jersey | United States | 08035 |
| 24 | Lourdes Cardiology Services | Voorhees | New Jersey | United States | 08043 |
| 25 | Presbyterian Heart Group | Albuquerque | New Mexico | United States | 87106 |
| 26 | Maimonides Medical Center | Brooklyn | New York | United States | 11219 |
| 27 | Coney Island Hospital | Brooklyn | New York | United States | 11235 |
| 28 | Cardiovascular Group of Syracuse | Liverpool | New York | United States | 13088 |
| 29 | High Point Regional Health (formerly Carolina Cardiology Cornerstone) | High Point | North Carolina | United States | 27262 |
| 30 | CarolinaEast Heart Center | New Bern | North Carolina | United States | 28562 |
| 31 | VA Medical Center Cleveland | Cleveland | Ohio | United States | 44106 |
| 32 | Great Lakes Medical Research, LLC | Willoughby | Ohio | United States | 44094 |
| 33 | Integris Baptist Medical Center | Oklahoma City | Oklahoma | United States | 73112 |
| 34 | Providence Heart and Vascular Institute | Portland | Oregon | United States | 97225 |
| 35 | Lehigh Valley Hospital | Allentown | Pennsylvania | United States | 18105 |
| 36 | Lancaster General Hospital | Lancaster | Pennsylvania | United States | 17602 |
| 37 | Arrhythmia Institute | Newtown | Pennsylvania | United States | 18940 |
| 38 | The Stern Cardiovascular Foundation | Germantown | Tennessee | United States | 38138 |
| 39 | HeartPlace | Bedford | Texas | United States | 76021 |
| 40 | VA Medical Center Dallas | Dallas | Texas | United States | 75216 |
| 41 | Cardiology Care Consultants | El Paso | Texas | United States | 79936 |
| 42 | Scott & White Memorial Hospital | Temple | Texas | United States | 76508 |
| 43 | Heart of Dixie Cardiology (formerly Dixie Regional Medical Center - River Road Campus) | Saint George | Utah | United States | 84790 |
| 44 | Mary Washington Hospital | Fredericksburg | Virginia | United States | 22401 |
| 45 | Virginia Cardiovascular Specialists | Richmond | Virginia | United States | 23229 |
| 46 | Aurora Medical Group | Milwaukee | Wisconsin | United States | 53215 |
| 47 | Ziekenhuis Oost-Limburg | Genk | Limburg | Belgium | 3600 |
| 48 | Royal Alexandra Hospital | Edmonton | Alberta | Canada | T5H 3V9 |
| 49 | St. Boniface General Hospital | Winnipeg | Manitoba | Canada | R2H 2A6 |
| 50 | QE II Health Sciences | Halifax | Nova Scotia | Canada | B3H 3A7 |
| 51 | Kingston General Hospital | Kingston | Ontario | Canada | K7L 2V7 |
| 52 | London Health Sciences Centre | London | Ontario | Canada | N6A 5A5 |
| 53 | Rouge Valley Centenary | Scarborough | Ontario | Canada | M1B 4Z8 |
| 54 | Institut de Cardiologie de Montreal (Montreal Heart Inst.) | Montreal | Quebec | Canada | H1T1C8 |
| 55 | Universitäts-Herzzentrum Freiburg - Bad Krozingen | Bad Krozingen | Germany | 79189 | |
| 56 | Tokyo Women's Medical University | Shinjuku-Ku | Kanto | Japan | 162-8666 |
| 57 | Osaka City University Hospital | Abeno-ku | Osaka | Japan | 545-8565 |
| 58 | Jichi Medical University Hospital | Shimotsuke-shi | Tochigi-ken | Japan | 329-0498 |
| 59 | Mc-Tronik | Lodz | Poland | ||
| 60 | Santa Maria Hospital | Lisboa | Lisbon | Portugal | 1649-035 |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Study Director: Grant Kim, Abbott Medical Devices
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT02235545
Other Study ID Numbers:
- 60045220
First Posted:
Sep 10, 2014
Last Update Posted:
Jan 15, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Abbott Medical Devices
Additional relevant MeSH terms: