Clinical trials: active, sponsored by Medtronic
Cardiac Rhythm Disorders, Urological Disorders
Product Surveillance Registry
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products.
- Conditions
- Cardiac Rhythm Disorders, Urological Disorders, Neurological Disorders, Cardiovascular Disorders
- Trial name
- PSR (NCT01524276)
- Where
- 402 sites in United States, Argentina and 39 more
- Volunteers
- 100,000 people
- Sponsor
- Medtronic
Bradycardia
Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers
The primary purpose of the study is to meet the CMS mandated Coverage with Evidence Development requirement in the National Coverage Determination for Leadless Pacemakers as they apply to Medtronic Micra devices.
- Trial name
- Micra CED (NCT03039712)
- Where
- United States
- Volunteers
- 37,000 people
- Sponsor
- Medtronic
Bradycardia
Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers (Micra AV CED)
The primary purpose of the study is to meet the CMS mandated Coverage with Evidence Development requirement in the National Coverage Determination for Leadless Pacemakers as they apply to Medtronic Micra devices.
- Trial name
- NCT04235491
- Where
- United States
- Volunteers
- 37,000 people
- Sponsor
- Medtronic
Ventricular Arrhythmia, Tachycardia
Enlighten Study: The EV-ICD Post Approval Registry
Medtronic is sponsoring Enlighten: The EV-ICD Post Approval Registry, to further confirm safety and effectiveness of EV-ICD in routine clinical practice, following commercial release of EV-ICD devices.
- Trial name
- NCT06048731
- Testing
- Defibrillation using EV-ICD
- Where
- 130 sites in United States, Austria and 22 more
- Volunteers
- 1,000 people
- Sponsor
- Medtronic
Chronic Pain, Intractable Pain
Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy
The PERSIST study is being conducted within Medtronic's active post-market surveillance platform, the Product Surveillance Registry (PSR).
- Trial name
- PERSIST (NCT07507422)
- Testing
- Commercially available Inceptiv™ neurostimulation systems
- Where
- 6 sites in United States, France
- Volunteers
- 970 people
- Sponsor
- Medtronic
Arrhythmia, Bradycardia
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
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…
- Conditions
- Arrhythmia, Bradycardia, Heart Failure, Sinus Tachycardia
- Trial name
- PPR (NCT00271180)
- Testing
- Device
- Where
- 333 sites in United States, Australia and 33 more
- Volunteers
- 20,000 people
- Sponsor
- Medtronic
Tachyarrhythmia
Lead Evaluation for Defibrillation and Reliability Post Approval Study
Medtronic is sponsoring the LEADR PAS to provide continuing evaluation and periodic reporting of safety and effectiveness of the OmniaSecure™ defibrillation lead following commercial release.
- Trial name
- LEADR PAS (NCT07005232)
- Testing
- defibrillation lead
- Where
- 73 sites in United States, Austria and 5 more
- Volunteers
- 2,000 people
- Sponsor
- Medtronic
Chronic Rhinosinusitis (CRS)
Propel Drug-Eluting Sinus Implant Family IBUKI Cohort
To confirm clinical safety and performance for the PROPEL family of products when used according to IFUs and standard of care in Japan.
- Trial name
- NCT07546682
- Testing
- None, observational standard of care study
- Where
- Japan
- Volunteers
- 100 people
- Sponsor
- Medtronic
Bradycardia
Micra Transcatheter Pacing System Post-Approval Registry
Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the Micra Transcatheter Pacing System (Micra system) when used as intended, in "real-world" clinical practice, following commercial…
- Trial name
- NCT02536118
- Testing
- Micra Transcatheter Pacing System
- Where
- 156 sites in United States, Belgium and 22 more
- Volunteers
- 3,100 people
- Sponsor
- Medtronic
Heart Failure
Personalized Therapy Study - Attain Stability Quad Post-Approval Study
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.
- Trial name
- ASQ (NCT04024943)
- Testing
- Quadripolar LV Lead
- Where
- 115 sites in United States, France and 7 more
- Volunteers
- 1,092 people
- Sponsor
- Medtronic
Heart Failure
Personalized Therapy Study - HFRS (TriageHF) Post Approval Study
Medtronic is sponsoring the HFRS PAS to evaluate the HFRS feature (TriageHF) when used in routine clinical practice following commercial release.
- Trial name
- NCT04489225
- Testing
- Observational
- Where
- 92 sites in United States, France and 7 more
- Volunteers
- 2,200 people
- Sponsor
- Medtronic
Ventricular Tachycardia
Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)
Medtronic is sponsoring the Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS) to further confirm safety and effectiveness of ventricular iATP therapy in routine clinical practice, following commercial release of…
- Trial name
- NCT04496518
- Testing
- Intrinsic Antitachycardia Pacing (iATP) Therapy
- Where
- 92 sites in United States, France and 7 more
- Volunteers
- 2,200 people, healthy volunteers welcome
- Sponsor
- Medtronic
Arteriovenous Fistula, Arteriovenous Fistula Stenosis
IN.PACT™ AV Access Post-Approval Study (PAS002)
Long-term safety will be summarized
- Conditions
- Arteriovenous Fistula, Arteriovenous Fistula Stenosis, Arteriovenous Fistula Occlusion, Fistula
- Trial name
- NCT04543539
- Testing
- IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort, IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort
- Where
- 20 sites in United States
- Volunteers
- 240 people
- Sponsor
- Medtronic