Status:
ACTIVE_NOT_RECRUITING
Personalized Therapy Study - Attain Stability Quad Post-Approval Study
Lead Sponsor:
Medtronic
Conditions:
Heart Failure
Eligibility:
All Genders
Brief Summary
The purpose of this Post-Approval Study (PAS) is to evaluate the long-term performance of the Model 4798 Left Ventricular (LV) lead in a real-world patient population. Patients will be followed for th...
Detailed Description
The Attain Stability Quad (ASQ) PAS is a multi-center, single arm, prospective observational study. However, in the US, retrospective enrollments from participants in the IDE study (IDE #G170020) are ...
Eligibility Criteria
Inclusion
- Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- Patient has or is intended to receive or be treated with a Model 4798 lead and a Medtronic CRT device
- Patient within 30 days of therapy received at the time of their initial PSR platform enrollment
Exclusion
- Patient who is, or is expected to be inaccessible for follow-up
- Patient with exclusion criteria required by local law
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Key Trial Info
Start Date :
August 21 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2028
Estimated Enrollment :
1092 Patients enrolled
Trial Details
Trial ID
NCT04024943
Start Date
August 21 2017
End Date
January 1 2028
Last Update
September 29 2025
Active Locations (115)
Enter a location and click search to find clinical trials sorted by distance.
1
Alaska Heart
Anchorage, Alaska, United States, 99508-4673
2
Southwest EP
Chandler, Arizona, United States, 85295-1680
3
Cardiology Associates of Northeast Arkansas
Jonesboro, Arkansas, United States, 72410-4163
4
Saint Vincent Heart Clinic Arkansas
Little Rock, Arkansas, United States, 72205-6202