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Personalized Therapy Study - Attain Stability Quad Post-Approval Study

Study acronym: ASQ
StatusActive, Not Recruiting
PhaseNot specified
SponsorMedtronic
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv11
  2. Minor Primary completion date: Jan 2027 to Jul 2027
    • Study completion date: Apr 2027 to Jan 2028
    v10
  3. Minor Enrollment target: 1008 to 1092v9
  4. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1000 to confirmed 1008
    • Site details revised at 115 of 115 sites
    v8
  5. Minor Study sites revised (115)v7
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  1. Minor Study sites: 87 to 115v6
  2. Minor Study sites: 23 to 87v5
  3. Minor Site contacts updated at 23 of 23 sitesv4
  4. Minor Study sites: 30 to 23v3
  5. Minor Study sites: 16 to 30
    • Study title expanded, about 1 word
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
16 trials monitored
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8,786 trials monitored
See 412 trials at risk
1,995 trials monitored
See 111 trials at risk
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 the duration of the PAS. This study is required by FDA as a condition of approval of the Model 4798 LV lead and is integrated within the Product Surveillance Registry (PSR).
Trial Details
NCT Number NCT04024943
Lead Sponsor Medtronic
Conditions
(from sponsor)
Heart Failure
Related terms Heart Failure
Enrollment 1,092 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov