Status:
COMPLETED
MultiPoint Pacing™ Post Market Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 2,000 patients with successful St. Jude Medical (SJM) Cardiac Resynchronization Therapy (CR...
Detailed Description
Any patient who received a market approved SJM Quadra Allure MP, Quadra Assura MP, or newer SJM CRT MP device is eligible for enrollment in the study. MultiPoint Pacing (MPP) programming guidance will...
Eligibility Criteria
Inclusion
- Are scheduled to receive a new CRT implant or an upgrade from an existing implantable cardioverter defibrillator or pacemaker implant (SJM CRT MP device and SJM Quadripolar Lead) with no prior left ventricular lead placement
- Have the ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion
- Are expected to receive a heart transplant during the duration of the study
- Have an epicardial ventricular lead system (Active or Inactive)
- Are less than 18 years of age
- Are currently participating in a clinical investigation including an active treatment arm and belong to the active arm
- Are not expected to complete the study follow-up schedule or duration due to any health condition other than heart failure, such as malignancy, indication for heart transplant or hospice care
Key Trial Info
Start Date :
July 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 15 2019
Estimated Enrollment :
2169 Patients enrolled
Trial Details
Trial ID
NCT02832622
Start Date
July 1 2016
End Date
July 15 2019
Last Update
February 17 2021
Active Locations (128)
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1
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States, 35249
2
Heart Center Research, LLC.
Huntsville, Alabama, United States, 35801
3
Integrated Medical Services
Avondale, Arizona, United States, 85392
4
Cardiovascular Consultants Ltd
Glendale, Arizona, United States, 85306