Short- and Long-Term Risk of Lead Dislodgement Events: Real-World Experience From Product Surveillance Registry.
Dingxin Qin, Andreas Filippaios, Jeffrey Murphy...
https://pubmed.ncbi.nlm.nih.gov/35925831/Actively Recruiting
Led by Medtronic · Updated on 2026-07-17
100000
Participants Needed
400
Research Sites
N/A
Total Duration
This registry study is designed to continuously evaluate and periodically report the safety and effectiveness of Medtronic medical products that are already available on the market. It aims to support patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying clinical surveillance and promoting advanced performance assessments with minimal burden. Participants include patients who have or are planned to receive an eligible Medtronic product. Enrollment can occur at any time relative to therapy start or retrospectively. The study involves ongoing data collection related to the use of these products in routine clinical care. Throughout participation, patients are monitored for safety and effectiveness outcomes approximately every 6 to 12 months, depending on the therapy. Data gathered helps assess product performance over time while minimizing additional visits or procedures. Follow-up continues until the studys completion, which extends to the year 2040.
CONDITIONS
Product Surveillance Registry
M
Medtronic Product Surveillance Registry
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Medtronic
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 28 years
Participants are monitored for safety and effectiveness of their Medtronic products through data collection during routine care.
Follow-ups every 6 to 12 months depending on therapy
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Lead Sponsor