Clinical trials: sponsored by Medtronic
Moderate Aortic Valve Stenosis
Evolut™ EXPAND TAVR II Pivotal Trial
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
- Trial name
- NCT05149755
- Testing
- Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)
- Where
- 94 sites in United States, Australia and 14 more
- Volunteers
- 650 people
- Sponsor
- Medtronic Cardiovascular
Severe Tricuspid Regurgitation
Transcatheter Tricuspid Valve Replacement With the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation
This clinical trial evaluates the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in symptomatic patients with severe or greater tricuspid regurgitation.
- Trial name
- PATHFINDER (NCT07321899)
- Testing
- Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System, Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System
- Where
- 13 sites in United States
- Volunteers
- 1,186 people
- Sponsor
- Medtronic Cardiovascular
Valve Disease, Heart
Medtronic Cardiac Surgery PMCF Registry
This registry is being conducted to support ongoing post-market surveillance activities.
- Trial name
- NCT04073420
- Testing
- Surgical Heart Valve Repair Products, Surgical Heart Valve Replacement Products
- Where
- 26 sites in United States, Austria and 8 more
- Volunteers
- 2,700 people
- Sponsor
- Medtronic Cardiac Surgery
Aortic Stenosis
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- RESTORE (NCT06777368)
- Testing
- Medtronic TAV, Edwards TAV
- Where
- 71 sites in United States
- Volunteers
- 225 people
- Sponsor
- Medtronic Cardiovascular
Type I Diabetes
Clinical Evaluation of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in Adult Subjects With Type 1 Diabetes (CIP347)
The purpose of this study is to evaluate the clinical performance of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in adult patients with Type 1 diabetes mellitus that cannot be controlled with subcutaneous insulin…
- Trial name
- Phoenix CIP347 (NCT06739811)
- Testing
- Implantable Insulin Pump System
- Where
- 11 sites in France, Netherlands
- Volunteers
- 40 people
- Sponsor
- Medtronic MiniMed, Inc.
Diabetes (Insulin-requiring, Type 1 or Type 2)
Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes (NEXUS)
This study will demonstrate the safety and performance of the Novel Medtronic Experimental Automated Insulin Delivery system named MiniMed™ NMX8 system in people living with insulin-requiring diabetes in comparison with the…
- Trial name
- NEXUS (NCT07227805)
- Testing
- NMX8, 780G
- Where
- 9 sites in Belgium, Denmark and 2 more
- Volunteers
- 116 people
- Sponsor
- Medtronic MiniMed, Inc.
Bradycardia
Impact of Allometric Pacing Rate on Ventricular Diastolic Function and Cerebral Blood Flow in Hypertensive Patients With Sinus Node Dysfunction
The study is a prospective, randomized controlled study in hypertensive patients with a bradycardia indications for pacing therapy and a plan to receive dual-chamber pacemaker.
- Trial name
- NCT07589452
- Testing
- Personalized lower rate pacing, Standard lower rate pacing
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Safety and Performance of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation
A prospective, single-arm, multi-center study to evaluate the safety, performance, and effectiveness of the Affera SpherePVI™ Multi-Ablation System for treating paroxysmal atrial fibrillation.
- Trial name
- SpherePVI (NCT05115214)
- Testing
- SpherePVI™ Catheter
- Where
- 2 sites in Czechia
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Mitral Valve Regurgitation
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
- Trial name
- APOLLO (NCT03242642)
- Testing
- Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
- Where
- 85 sites in United States, Canada and 1 more
- Volunteers
- 1,056 people
- Sponsor
- Medtronic Cardiovascular
Atrial Fibrillation
Safety and Performance of the SpherePVI™ Catheter to Treat Paroxysmal Atrial Fibrillation
A prospective, single-arm, single-center study to evaluate the safety, performance, and effectiveness of the SpherePVI™ Catheter for treating paroxysmal AF.
- Trial name
- SpherePVI (NCT05144503)
- Testing
- SpherePVI™ Catheter
- Where
- Lithuania
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Intracranial Aneurysm, Stroke, Ischemic
Neurovascular Product Surveillance Registry
Post market surveillance registry
- Trial name
- INSPIRE (NCT02988128)
- Testing
- Treatment for intracranial aneurysms, Treatment for Acute Ischemic Stroke
- Where
- 99 sites in Argentina, Australia and 22 more
- Volunteers
- 4,000 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
AAA - Abdominal Aortic Aneurysm
Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System China Study(ATHENA)
To evaluate the safety and effectiveness of the Heli-FX EndoAnchor system in AAA subjects who without augmented radial fixation and/or sealing due to an endoleak or migration are at high risk for aneurysm-related complications or…
- Trial name
- ATHENA (NCT07754318)
- Testing
- Heli-FX EndoAnchor System
- Where
- China
- Volunteers
- 142 people
- Sponsor
- Medtronic Cardiovascular
Disc Degeneration, Spinal Deformity
MDT-0123 Japan Study
The purpose of this clinical trial is to compare the efficacy and safety of this investigational device with autologous iliac bone graft (ICBG) in patients who are deemed to require bone fusion through spinal fixation at two…
- Trial name
- NCT07414745
- Testing
- MDT-0123, ICBG
- Where
- 14 sites in Japan
- Volunteers
- 140 people
- Sponsor
- Medtronic Spinal and Biologics
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
Ventricular Tachycardia (VT)
Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)
Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and treated with the…
- Trial name
- NCT06703489
- Testing
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Paroxysmal AF
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives.
- Trial name
- Horizon 360 (NCT07308847)
- Testing
- Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System
- Where
- 24 sites in United States
- Volunteers
- 300 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes
The purpose of this study is to check that a new insulin pump, called NMX8, is safe when used with a continuous glucose monitoring sensor called Disposable Sensor 5/Simplera Sync in people with diabetes.
- Trial name
- NCT07228117
- Testing
- MiniMed™ NMX8-AID System with DS5™/Simplera Sync™
- Where
- 33 sites in United States, Australia and 1 more
- Volunteers
- 389 people
- Sponsor
- Medtronic MiniMed, Inc.
Colorectal Anastomosis, Left-sided Colon Resection
Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections
The purpose of this study is to evaluate the safety and performance of the Signia™ power handle, Signia™ circular adapter, and Signia™ Tri-Staple™ 2.0 circular reloads (hereafter referred to as Signia™ circular stapler) in…
- Conditions
- Colorectal Anastomosis, Left-sided Colon Resection, Anastomotic Leak, Anastomotic Complication
- Trial name
- SECURE (NCT07351071)
- Testing
- Signia™ circular stapler with Tri-Staple™ Technology (Signia™ Circular Stapling system)
- Where
- 10 sites in United States
- Volunteers
- 137 people
- Sponsor
- Medtronic - MITG
Paroxysmal Atrial Fibrillation (PAF)
Sphere-9 PAF China Study
The goal of this clinical trial is to find out if the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System is safe and works to treat recurrent symptomatic paroxysmal atrial fibrillation (PAF) in adults who have…
- Trial name
- NCT07789925
- Testing
- Catheter ablation using Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation System
- Where
- 10 sites in China
- Volunteers
- 180 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Heart Failure NYHA Class II, Heart Failure NYHA Class III
Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure
The ALLEVIATE-HF study is a prospective, randomized, controlled, blinded, multi-site, interventional, investigational device exemption (IDE) pivotal study.
- Trial name
- ALLEVIATE-HF (NCT04452149)
- Testing
- Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download, Medication intervention, Not Randomized to Device or Medication Intervention
- Where
- 53 sites in United States
- Volunteers
- 826 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure