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Primary and study completion dates: Dec 2024 to Dec 2040
Study sites: 221 to 212
v18
NotableLead sponsor: Medtronic Cardiac Rhythm and Heart Failure to Medtronic
Enrollment target: 15000 to 13000
Study sites: 15 to 221
v17
MinorStudy sites: 13 to 15v16Show 4 more changesShow less
Primary and study completion dates: Dec 2024
Eligibility criteria shortened, about 31 words
Study description expanded, about 20 words
Study title expanded, about 2 words
MinorRe-verified, no change to tracked fieldsv15
MinorStudy sites: 42 to 13v14
NotablePrimary endpoint revised
Study sites: 107 to 42
Eligibility criteria revised
v13
MinorRe-verified, no change to tracked fieldsv12
MinorStudy sites: 78 to 107
Study title expanded, about 2 words
v11
MinorStudy sites: 44 to 78
Eligibility criteria expanded, about 70 words
v10
MinorStudy sites: 30 to 44
Eligibility criteria expanded, about 86 words
v9
MinorRe-verified, no change to tracked fieldsv8
Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.