Clinical trials: sponsored by Medtronic
Ventricular Tachyarrhythmia
Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP)
The LEADR study is designed to assess the safety and efficacy of the Next Generation ICD lead. The LEADR LBBAP study is being conducted under the existing US FDA Investigational Device Exemption (IDE) for the Next Generation ICD…
- Trial name
- NCT04863664
- Testing
- Defibrillation (RV Implant), Defibrillation (LBBAP Implant)
- Where
- 55 sites in United States, Australia and 18 more
- Volunteers
- 1,007 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Valve Stenosis
Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients
The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe…
- Trial name
- NCT02701283
- Testing
- Medtronic Transcatheter Aortic Valve Replacement Systems, Surgical Aortic Valve Replacement (SAVR)
- Where
- 87 sites in United States, Australia and 5 more
- Volunteers
- 2,223 people
- Sponsor
- Medtronic Cardiovascular
Juvenile Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis
Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis
The purpose of this study was to establish probable benefits and evaluate the safety and preliminary effectiveness of the Braive™ GMS when used in the treatment of pediatric progressive scoliosis.
- Trial name
- BRAIVE IDE (NCT04929678)
- Testing
- Braive™ Growth Modulation System (Braive™ GMS)
- Where
- 4 sites in United States, Canada and 1 more
- Volunteers
- 10 people
- Sponsor
- Medtronic Spinal and Biologics
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients…
- Trial name
- SURTAVI (NCT01586910)
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 86 sites in United States, Canada and 7 more
- Volunteers
- 1,746 people
- Sponsor
- Medtronic Cardiovascular
Symptomatic Aortic Stenosis
Optimize PRO Study
The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and…
- Trial name
- NCT04091048
- Testing
- Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)
- Where
- 60 sites in United States, Australia and 10 more
- Volunteers
- 1,127 people
- Sponsor
- Medtronic Cardiovascular
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
Congenital Heart Disease, Tetrology of Fallot
The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of…
- Conditions
- Congenital Heart Disease, Tetrology of Fallot, RVOT Anomaly, Pulmonary Regurgitation
- Trial name
- NCT02979587
- Testing
- Harmony TPV System
- Where
- 12 sites in United States, Canada and 1 more
- Volunteers
- 86 people
- Sponsor
- Medtronic Heart Valves
Bradycardia, Slow Heart Beat
EMRI SureScan™ Clinical Study
The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing System (used in support of Revo MRI™ SureScan…
- Trial name
- NCT00433654
- Testing
- Implantable Pulse Generator (IPG) and Pacing Leads (wires), Magnetic Resonance Imaging (MRI) scan
- Where
- 45 sites in United States, Austria and 9 more
- Volunteers
- 484 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Type 1 Diabetes
Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control at Home
The purpose of this study is to evaluate the safety and effectiveness of the Hybrid Closed Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home setting.
- Trial name
- NCT02748018
- Testing
- 670G and 770G Insulin Pump, Subject's Current Diabetes Therapy
- Where
- 36 sites in United States, Canada and 7 more
- Volunteers
- 959 people
- Sponsor
- Medtronic MiniMed, Inc.
Brief Loss of Consciousness
Applicability of Syncope Guidelines in Cataluña
The aim of SYNCAT study is to study the level of adherence of the centers in Cataluña tu the Syncope Guidelines ESC2009 for the diagnosis and treatment of syncope and the impact that following them can have in the prognosis of…
- Trial name
- SYNCAT (NCT01721369)
- Testing
- Transient Loss of Consciousness (T-LOC)
- Volunteers
- 581 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
CareLink® Network Evaluation
The purpose of the study is to demonstrate the value of the Medtronic CareLink® Network in clinical practice in the country specific healthcare setting.
- Trial name
- NCT01023022
- Testing
- Medtronic CareLink® Network
- Where
- 10 sites in Poland
- Volunteers
- 176 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Type 1 Diabetes
Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp®
This global study (US, Canada, and Australia) will evaluate the safety and effectiveness of the MiniMed 780G system in type 1 adult and pediatric subjects utilizing Fiasp (insulin aspart injection) in a home setting.
- Trial name
- NCT05224258
- Testing
- MiniMed 780G System
- Where
- 18 sites in United States, Australia and 1 more
- Volunteers
- 240 people
- Sponsor
- Medtronic MiniMed, Inc.
Diabetes type1, Children, Only
Evaluation of the MiniMed 780 System in Paediatric Subjects
The purpose of this study is to demonstrate the safety and performance of the MiniMed™ 780G system in pediatric subjects (2-6 years old) with type 1 diabetes in a home setting.
- Trial name
- LENNY (NCT05574062)
- Testing
- MiniMed 780G Auto Mode with G4S sensor, MiniMed 780G Manual Mode with G4S sensor, MiniMed 780G Auto Mode with DS5 sensor
- Where
- 12 sites in Finland, Italy and 2 more
- Volunteers
- 101 people
- Sponsor
- Medtronic MiniMed, Inc.
Type 1 Diabetes
Safety and Effectiveness of the MiniMed™ 780G System With DS5 CGM
The purpose of this study is to confirm the safety and effectiveness of the MiniMed 780G insulin pump used in combination with the DS5 CGM in type 1 diabetes adult and pediatric subjects in a home setting.
- Trial name
- NCT05714059
- Testing
- Insulin Pump with Continuous Glucose Monitoring
- Where
- 23 sites in United States
- Volunteers
- 250 people
- Sponsor
- Medtronic MiniMed, Inc.
Type 1 Diabetes
Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adults and Pediatrics Utilizing Lyumjev®
This US study will evaluate the safety and effectiveness of utilizing insulin Lyumjev® lispro-aabc in the MiniMed™ 780G System in Type 1 adult and pediatric subjects in a home setting to support product and system labeling.
- Trial name
- NCT05325294
- Testing
- MiniMed 780G System
- Where
- 19 sites in United States
- Volunteers
- 244 people
- Sponsor
- Medtronic MiniMed, Inc.
Type 1 Diabetes Mellitus
Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System
This study is a Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects.
- Trial name
- NCT03959423
- Testing
- AHCL insulin pump system
- Where
- 17 sites in United States
- Volunteers
- 288 people
- Sponsor
- Medtronic MiniMed, Inc.
Type 1 Diabetes Mellitus
Use of the Guardian™ Connect System With Smart Connected Devices
The purpose of this study is to collect sensor, insulin, sleep, activity and food/meal data for a minimum of 90 days of device wear (Phase 1) and up to a maximum of 9 months of device wear (Phase 2) with optional insulin…
- Trial name
- NCT04809285
- Testing
- Guardian™ Connect system, InPen™ Basal smart cap, smart insulin pens, and InPen™ Diabetes Management app
- Where
- 14 sites in United States
- Volunteers
- 217 people
- Sponsor
- Medtronic MiniMed, Inc.
Type 1 Diabetes
The MiniMed™ 780G Glycemic Control and Quality of Life Study for the Treatment of Pediatric and Adult Subjects With Type 1 Diabetes in France.
The purpose of the study is to evaluate the efficacy in glycemic control and the impact on the quality of life of patients using the MiniMed™ 780G System for the treatment of Type 1 diabetes, in real life settings in France.
- Trial name
- NCT04308291
- Testing
- MiniMed™ 780G System
- Where
- 32 sites in France
- Volunteers
- 306 people
- Sponsor
- Medtronic MiniMed, Inc.
Conductive Hearing Loss, Single-Sided Deafness
Ambispective Clinical Evaluation of Sophono™
Study to accumulate post-market clinical evidence for the safety and effectiveness of the Sophono Alpha 2 and Alpha 2 Maximum Power Output (MPO) systems in subjects diagnosed with conductive hearing loss, single-sided deafness…
- Conditions
- Conductive Hearing Loss, Single-Sided Deafness, Mixed Hearing Loss
- Trial name
- ACES (NCT03143257)
- Testing
- Sophono Bone Conduction Hearing Systems
- Where
- 6 sites in United States
- Volunteers
- 71 people
- Sponsor
- Medtronic Surgical Technologies
Aortic Stenosis
PERIGON Japan Trial
The purpose of this study is to evaluate the safety and effectiveness of the 17mm MDT-2215 aortic valve bioprosthesis.
- Trial name
- NCT02686814
- Testing
- 17mm MDT-2215 aortic valve bioprosthesis
- Where
- 10 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Medtronic Cardiac Surgery