Clinical trials: 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
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
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
Bradycardia
Micra AV Transcatheter Pacing System Post-Approval Registry
Medtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care…
- Trial name
- Micra AV PAS (NCT04253184)
- Testing
- Micra AV Transcatheter Pacing System
- Where
- 89 sites in United States, Belgium and 18 more
- Volunteers
- 802 people
- Sponsor
- Medtronic
Minimally Invasive Surgical Procedures, Surgical Procedures, Operative
Medtronic Signia SDR Product Surveillance Registry
The purpose of the registry is to confirm the safety and performance of the Signia™ Small Diameter Reload (SDR) when used in surgical procedures in a real-world setting in patients receiving surgery for indicated thoracic…
- Trial name
- NCT05095935
- Testing
- N/A observational registry
- Where
- 14 sites in United States
- Volunteers
- 430 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
Chronic Pain, Spasticity, Muscle
Medtronic PSR TDD PMCF
The purpose of this study is to provide continuing evaluation and reporting of safety and performance of the SynchroMed II Infusion System within its intended use. Data will support post-market surveillance obligations.
- Trial name
- NCT04714385
- Where
- 15 sites in Belgium, Czechia and 6 more
- Volunteers
- 209 people
- Sponsor
- Medtronic
Cardiac Rhythm Disorder
3T MRI CIED Post-Approval Study
The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure.
- Trial name
- NCT02969395
- Where
- 204 sites in United States, Belgium and 20 more
- Volunteers
- 41 people
- Sponsor
- Medtronic
Heart Failure
Personalized CRT - PSR
The purpose of this study is to evaluate the cardiac resynchronization therapy (CRT) response in a real-world patient population and evaluate options to address non-response and patient management.
- Trial name
- NCT03723265
- Testing
- Cardiac Resynchronization Therapy
- Where
- 122 sites in United States, Belgium and 11 more
- Volunteers
- 1,517 people
- Sponsor
- Medtronic
Heart Failure
The Product Surveillance Registry REVERSE Post Approval Study
The purpose of the REVERSE Post Approval Study (PAS) is to confirm the benefit observed in the REVERSE and RAFT pivotal studies in "real-world" clinical practice.
- Trial name
- PSR-REVERSE (NCT01660035)
- Where
- 123 sites in United States, Belgium and 8 more
- Volunteers
- 155 people
- Sponsor
- Medtronic
Heart Failure
Attain Performa™ Left Ventricular (LV) Quadripolar Leads Chronic Performance Study
Lead survivability will be summarized.
- Trial name
- NCT02294331
- Where
- 100 sites in United States, Belgium and 6 more
- Volunteers
- 1,900 people
- Sponsor
- Medtronic
Heart Failure
Model 4396 Left Ventricular (LV) Lead Chronic Performance Study
Lead survivability will be summarized.
- Trial name
- NCT01361685
- Where
- 52 sites in United States, Canada and 1 more
- Volunteers
- 366 people
- Sponsor
- Medtronic
Heart Failure
Personalized CRT - MPP Post Approval Study
The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release.
- Trial name
- NCT03232944
- Testing
- Cardiac Resynchronization Therapy - MPP
- Where
- 78 sites in United States, Belgium and 11 more
- Volunteers
- 1,338 people
- Sponsor
- Medtronic
Heart Failure
Model 4296 Left Ventricular (LV) Lead Chronic Performance Study
Lead survivability will be summarized.
- Trial name
- NCT01361672
- Where
- 99 sites in United States, Canada and 1 more
- Volunteers
- 1,140 people
- Sponsor
- Medtronic