Clinical trials: sponsored by Medtronic
Bicuspid Aortic Valve
Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
- Trial name
- NCT03635424
- Testing
- Medtronic TAVR Systems
- Where
- 25 sites in United States
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiovascular
Severe Aortic Stenosis
Safety & Efficacy Study of the Medtronic CoreValve® System-Treatment of Symptomatic Severe Aortic Stenosis With Significant Comorbidities in Extreme Risk Subjects Who Need Aortic Valve Replacement
To evaluate the safety and efficacy of the Medtronic CoreValve® System for the treatment of symptomatic severe aortic stenosis in subjects with significant comorbidities in whom the risk of surgical aortic valve replacement has a…
- Trial name
- NCT01675440
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 43 sites in United States
- Volunteers
- 782 people
- Sponsor
- Medtronic Cardiovascular
Inguinal Hernia, Ventral Hernia
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Hernia Surgery (Enable Hernia Repair)
A prospective, multicenter, single-arm pivotal study will be performed with 192 subjects enrolled to have an inguinal or ventral robotic hernia repair procedure using the Medtronic Hugo™ RAS system.
- Trial name
- NCT06445504
- Testing
- Robotic-Assisted Surgery (RAS) Hernia Repair Surgery
- Where
- 7 sites in United States
- Volunteers
- 206 people
- Sponsor
- Medtronic - MITG
Bradycardia Sinus, AV Block
The CT-verified Data Collection Study to Investigate the Correlation Between the Leadless Pacemaker Tip Location and Echo, ECG
The goal of this observational study is to assess inter-/intra- ventricular synchrony and ECG characteristics in relation to Micra tip location.
- Conditions
- Bradycardia Sinus, AV Block, Atrial Fibrillation (AF)
- Trial name
- NCT06910059
- Testing
- Observational
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Stenosis
PERIGON Pivotal Trial
To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.
- Trial name
- PERIGON (NCT02088554)
- Testing
- Model 400 aortic valve bioprosthesis
- Where
- 38 sites in United States, Canada and 6 more
- Volunteers
- 1,312 people
- Sponsor
- Medtronic Cardiac Surgery
Heart Failure
Characterizing Outcomes and Real-World Experience of Cardiac Physiologic Pacing (The CORE-CPP Study)
The purpose of this study is to use real-world evidence to validate that conduction system pacing (CSP), delivered via a Medtronic 3830 catheter-delivered lead and a Medtronic dual-chamber transvenous pacemaker, is a safe and…
- Trial name
- CORE-CPP (NCT06606288)
- Testing
- Conduction system pacing, Bi-ventricular pacing
- Where
- United States
- Volunteers
- 6,000 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Type 1 Diabetes (T1D)
Evaluation of the Safety and Effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in Adults Living With Type 1 Diabetes
The purpose of the study is to evaluate the safety and the effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery system, named MiniMed NMX8 system (referred also to as NMX8 system), in comparison with other…
- Trial name
- ELEVATE (NCT07401901)
- Testing
- NMX8 System - Treatment arm, AID Therapy, NMX8 System - Control Arm
- Where
- 21 sites in France, Germany and 4 more
- Volunteers
- 230 people
- Sponsor
- Medtronic MiniMed, Inc.
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
Aortic Valve Disease
Avalus Ultra Post-Approval Study (PAS)
The purpose of this study is to characterize the safety and effectiveness of the Medtronic Avalus Ultra aortic valve bioprosthesis in patients with aortic valve disease.
- Trial name
- NCT06506903
- Testing
- Medtronic Avalus Ultra
- Where
- 15 sites in United States
- Volunteers
- 190 people
- Sponsor
- Medtronic Cardiac Surgery
Type 2 Diabetes Treated With Insulin
In-Home Study With MiniMed™ 780G Pump Automated Control in Type 2-Evaluation of the AHCL System in Adults With Insulin-requiring Type 2 Diabetes
The objective of the study is to assess the safety and effectiveness of MiniMed™ 780G system in adult subjects with insulin-requiring type 2 diabetes in a home setting.
- Trial name
- NCT05238142
- Testing
- MiniMed™ 780G Insulin Pump system
- Where
- 31 sites in United States
- Volunteers
- 574 people
- Sponsor
- Medtronic MiniMed, Inc.
Aortic Aneurysm
ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry)
The ANCHOR registry is a multi-center, post-market, non-interventional, non-randomized, prospective study. Subjects must sign an ICF prior to obtaining any study specific information.
- Trial name
- ANCHOR (NCT01534819)
- Testing
- EndoAnchor™, endovascular treament
- Where
- 87 sites in United States, Australia and 11 more
- Volunteers
- 1,090 people
- Sponsor
- Medtronic Cardiovascular
Symptomatic Paroxysmal Atrial Fibrillation (PAF)
FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation
Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with paroxysmal atrial fibrillation.
- Trial name
- NCT01490814
- Testing
- Electrical isolation of the pulmonary veins, Electrical isolation of pulmonary veins
- Where
- 19 sites in Czechia, France and 6 more
- Volunteers
- 769 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Oxygen Saturation Measurement
Nellcor™ Abbreviated Sensor Additional Data Collection
To collect data on a variety of market approved Nellcor™ pulse oximetry sensors with the Nellcor™ Pulse Oximetry device to support the market approval.
- Trial name
- NCT07201961
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Newborn, Birth, Preterm
Pulse Oximetry Performance Comparison in Newborns
The overall purpose is to directly compare pulse rate (PR) acquisition and oxygen saturation performance between two pulse oximeters (PO) in newborns.
- Trial name
- NCT06637917
- Testing
- OxySoftN™ Neonatal-Adult SpO2 Sensor with N600X Nellcor™ Patient Monitoring System, LNCS® NEO SpO2 Sensor with RAD-97™ Pulse CO-Oximeter, 1041PTS (or similar) Kendall™ Neonatal Electrodes with IntelliVue MP5 Portable Patient Monitor
- Where
- 3 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Cardiovascular Diseases
Management of Device Detected AT and Impact of Device Treatment Algorithms on Atrial Fibrillation
The MANDATE-AF study was designed to address evidence needs in India for device-based management of AF using AT/AF (Atrial Tachycardia/Atrial fibrillation) diagnostic features and therapies such as Reactive Atrial anti…
- Trial name
- MANDATE-AF (NCT04172883)
- Testing
- Treatment arm
- Where
- 11 sites in India
- Volunteers
- 79 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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 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
Degenerative Disease of the Lumbosacral Spine
Transforaminal Lumbar Interbody Fusion (TLIF)
This is a global, multi-center, prospective, randomized, blinded, controlled pivotal study. Clinical and radiological evaluation will be performed preoperatively and postoperatively up to 24 months; and endpoint success will be…
- Trial name
- TLIF (NCT04073563)
- Testing
- Infuse™ Bone Graft (Infuse™), Intervertebral body fusion device and Medtronic posterior Fixation Systems
- Where
- 46 sites in United States, China
- Volunteers
- 600 people
- Sponsor
- Medtronic Spinal and Biologics
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
Heart Failure
PLASMA Mexico (PLASMA Mexico)
Collect data on Mexican patients diagnosed with Heart Failure with reduced ejection fraction, their treatments, and their progress in a real-world environment.
- Trial name
- NCT04214899
- Where
- 7 sites in Mexico
- Volunteers
- 254 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure