Clinical trials: sponsored by 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
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
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
Diabetes (DM), Diabetes (Insulin-requiring, Type 1 or Type 2)
MiniMed Fit Payload Wear Pediatric Study
The purpose of this study is to assess MiniMed Fit Payload adhesive components in different wear locations over a 7-day period to support development of the future commercialized patch pump in participants 7-17 years of age.
- Conditions
- Diabetes (DM), Diabetes (Insulin-requiring, Type 1 or Type 2), Diabetes in Children, Diabetes in Adolescence
- Trial name
- NCT07675161
- Testing
- MiniMed Fit Payload adhesive components
- Where
- 5 sites in United States
- Volunteers
- 59 people
- Sponsor
- Medtronic MiniMed, Inc.
Venous Reflux
VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial
Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous…
- Trial name
- NCT03820947
- Testing
- VenaSeal™ System, Endothermal Ablation (ETA), Surgical Stripping
- Where
- 32 sites in United States, Australia and 8 more
- Volunteers
- 506 people
- Sponsor
- Medtronic Endovascular
Spinal Deformity, Spinal Degenerative Disorder
The Ailliance Post-Market Clinical Study
The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and/or spinal indication(s). Subjects are enrolled and followed postoperatively to 24 months.
- Conditions
- Spinal Deformity, Spinal Degenerative Disorder, Spinal Fusion Failure, Spinal Trauma
- Trial name
- NCT05856370
- Testing
- Follow-up schedule: pre-operative baseline up to 24-months post-procedure
- Where
- 29 sites in United States, France and 4 more
- Volunteers
- 1,000 people
- Sponsor
- Medtronic Spinal and Biologics
Venous Embolism of Lower Extremities (Diagnosis), Arterial Embolism and Thrombosis
Case-Specific Health Care Professional Clinical Survey of Liberant™ Thrombectomy System
The purpose of Case-Specific Health Care Professional (HCP) Clinical Survey of Liberant™ Thrombectomy System, also known as the Liberant Clinical Assessment, is to collect first-in-human clinical data to confirm the safety and…
- Conditions
- Venous Embolism of Lower Extremities (Diagnosis), Arterial Embolism and Thrombosis, Acute DVT of Lower Extremity, Chronic DVT of Lower Extremity
- Trial name
- NCT07335341
- Testing
- Liberant Thrombectomy System
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic Endovascular
Ventral Hernia
AFFIX: Post-market Study of MaxTack™ Motorized Fixation Device in Subjects Undergoing Ventral Hernia Repair
Medtronic is sponsoring and funding the AFFIX study, a prospective, post-market, multicenter, nonrandomized, single-arm, interventional clinical study.
- Trial name
- AFFIX (NCT06710795)
- Testing
- MaxTack™ Motorized Fixation Device
- Where
- 3 sites in United States
- Volunteers
- 35 people
- Sponsor
- Medtronic - MITG
Intracranial Aneurysm
INSPIRE Pipeline™ Shield Post Approval Study
The purpose of the Pipeline™ Flex Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Shield PAS") is to collect on-label use data in patients undergoing treatment for intracranial aneurysms (IA)…
- Trial name
- NCT05071963
- Testing
- Treatment of Intracranial Aneurysms
- Where
- 16 sites in United States
- Volunteers
- 246 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Cardiovascular Diseases
Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery
The purpose of this observational, multi-center prospective, post-market registry is to confirm real-world device safety and performance, to ensure the continued acceptability of identified risks, and detect emerging risks.
- Trial name
- SYMBIOSIS (NCT04241328)
- Where
- 14 sites in Austria, Belgium and 6 more
- Volunteers
- 5,000 people
- Sponsor
- Medtronic Cardiac Surgery
Hypertension, Vascular Diseases
SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System
The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the presence of up to three standard antihypertensive medications.
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases
- Trial name
- NCT02439775
- Testing
- Symplicity Spyral™ multi-electrode renal denervation system
- Where
- 56 sites in United States, Australia and 8 more
- Volunteers
- 337 people
- Sponsor
- Medtronic Vascular
Bradycardia
Conduction System Pacing Display Research System for SmartSync Pacing System Analyzer
The purpose of this study is to collect and compare the heart's electrical activity data measured by the novel Conduction System Pacing (CSP) Display Research System with data measured via 12 lead electrocardiogram (ECG) from a…
- Trial name
- CSP Display (NCT07733960)
- Testing
- CSP Display research system
- Where
- 2 sites in India
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Acute Ischemic Stroke
REal-world Clinical evAulation of Medtronic NeurOVascular Products for Acute Ischemic Stroke (RECANOVA Registry)
Post-Market Registry
- Trial name
- RECANOVA (NCT07599904)
- Testing
- Mechanical Thrombectomy
- Where
- 3 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Heart Failure
Crome/Cobalt Respiration Study
The goal of this study is to compare measured respiration rates in various subject scenarios and use conditions between capnography and the Crome and Cobalt ICD and CRT-D MRI SureScan devices (derived using a Holter recorder).
- Trial name
- NCT06089694
- Testing
- Enabling Sensor Research Holter Mode feature
- Where
- 4 sites in United States
- Volunteers
- 61 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Hernia, Hernia, Ventral
Transorb™ Self-Gripping Resorbable Mesh in High-risk Subjects Undergoing Open Repair of Ventral Hernia
The purpose of RECOVER is to evaluate the performance and safety of Transorb™ self-gripping resorbable mesh in high-risk subjects (at least one risk factor impairing wound healing) when used for reinforcement of abdominal wall…
- Conditions
- Hernia, Hernia, Ventral, Hernia, Abdominal, Hernia Abdominal Wall
- Trial name
- RECOVER (NCT06449378)
- Testing
- Transorb™ Self-Gripping Resorbable Mesh
- Where
- 13 sites in United States, Belgium and 1 more
- Volunteers
- 163 people
- Sponsor
- Medtronic - MITG
Severe Pulmonary Valve Regurgitation
Harmony TPV EMEA PMS
The Harmony Transcatheter Pulmonary Valve (TPV) System is indicated for use in the management of pediatric and adult congenital heart disease patients with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as…
- Trial name
- NCT06906926
- Testing
- Certain imaging assessments can be non-Standard of Care
- Where
- 12 sites in Denmark, France and 6 more
- Volunteers
- 80 people
- Sponsor
- Medtronic Cardiovascular