Clinical trials: sponsored by 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
- 97 sites in United States, Austria and 7 more
- Volunteers
- 2,000 people
- Sponsor
- Medtronic
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
Prostatectomy, Cystectomy
Hugo™ RAS Urology Post-Market Clinical Study
The purpose of this study is to collect evidence on the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.
- Conditions
- Prostatectomy, Cystectomy, Nephrectomy, Urologic Cancer
- Trial name
- NCT07901049
- Testing
- Robotic Assisted Urologic Surgery
- Volunteers
- 110 people
- Sponsor
- Medtronic - MITG
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
Mitral Regurgitation
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in…
- Trial name
- APOLLO-EU (NCT05496998)
- Testing
- Medtronic Intrepid™ TMVR TF System
- Where
- 38 sites in Denmark, France and 6 more
- Volunteers
- 400 people
- Sponsor
- Medtronic Cardiovascular
Left Atrial Appendage Exclusion
CLIP-IT Post-Market Study
The purpose of this study is to collect post-market clinical evidence on performance and clinical outcomes of the Penditure™ Left Atrial Appendage (LAA) Exclusion System in subjects undergoing concomitant cardiac surgery.
- Trial name
- NCT06203054
- Testing
- Penditure™ Left Atrial Appendage (LAA) Exclusion System
- Where
- 15 sites in United States
- Volunteers
- 198 people
- Sponsor
- Medtronic Cardiac Surgery
Heart Failure With Preserved Ejection Fraction, Concentric Hypertrophy
Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction
FIRE-HFpEF is a multi-center, prospective, randomized, single-blinded, clinical feasibility study. This study will enroll up to 105 subjects with heart failure with preserved ejection fraction in the United States.
- Trial name
- FIRE-HFpEF (NCT05839730)
- Testing
- Pacemaker PLR + TRT ON, Pacemaker non-pacing mode or an exertional rate-adaptive pacing mode with no planned pacing at rest.
- Where
- 8 sites in United States
- Volunteers
- 105 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
PULSED AF Post-Approval Study
PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.
- Trial name
- NCT06578104
- Testing
- PulseSelect™ PFA system
- Where
- 23 sites in United States, Canada and 1 more
- Volunteers
- 580 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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
Ventricular Tachycardia
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Sphere VT is a prospective, multi-center, single-arm, unblinded pivotal clinical study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia (MMVT) due to prior myocardial infarction (MI) will be enrolled…
- Trial name
- NCT07585968
- Testing
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Where
- 7 sites in United States
- Volunteers
- 260 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Intracranial Aneurysm
NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study
The purpose of the Pipeline™ Vantage Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Vantage PAS") is to collect safety and effectiveness data in patients undergoing treatment for intracranial…
- Trial name
- NCT06604884
- Testing
- Treatment of Intracranial Aneurysms
- Where
- 10 sites in United States
- Volunteers
- 118 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Paroxysmal Atrial Fibrillation
STOP AF First Post-Approval Study
The STOP AF First PAS is a prospective, global, multi-center, observational trial.
- Trial name
- NCT05227053
- Testing
- Arctic Front™ Cardiac Cryoablation Catheter
- Where
- 11 sites in United States
- Volunteers
- 142 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Persistent Atrial Fibrillation
STOP Persistent AF PAS
The STOP Persistent AF Post Approval Study (PAS) is a prospective, global, multicenter, observational trial.
- Trial name
- NCT05005949
- Testing
- Arctic Front™ Cardiac Cryoablation Catheter System
- Where
- 17 sites in United States, Austria and 4 more
- Volunteers
- 393 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Hypertension
Global SYMPLICITY Registry (GSR) DEFINE
This is a prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document the long-term safety and effectiveness of renal denervation in a real world patient…
- Trial name
- NCT01534299
- Testing
- Medtronic Renal Denervation System
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 5,000 people
- Sponsor
- Medtronic Vascular
Ischemic Heart Disease, Stenotic Coronary Lesion
RESOLUTE ONYX China Single Arm Study
It is a single arm clinical evaluation of safety and efficacy of the Medtronic Resolute Onyx™ zotarolimus-eluting coronary stent system in subjects who are eligible for percutaneous transluminal coronary angioplasty (PTCA) in de…
- Conditions
- Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis
- Trial name
- NCT03471845
- Testing
- Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
- Where
- China
- Volunteers
- 591 people
- Sponsor
- Medtronic Vascular
Coronary Artery Disease
Prevail Global Study
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
- Trial name
- NCT06535854
- Testing
- Prevail DCB, Agent DCB
- Where
- 79 sites in United States, Canada and 7 more
- Volunteers
- 1,205 people
- Sponsor
- Medtronic Vascular
Ischemic Heart Disease, Stenotic Coronary Lesion
RESOLUTE ONYX China RCT Study
It is a randomized controlled trial to evaluate the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in comparison with the Medtronic Resolute Integrity™ Zotarolimus-Eluting coronary…
- Conditions
- Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis
- Trial name
- NCT03466151
- Testing
- Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
- Where
- 2 sites in China
- Volunteers
- 550 people
- Sponsor
- Medtronic Vascular
Hypertension, Vascular Diseases
SPYRAL GEMINI Pilot Study
The purpose of the SPYRAL GEMINI Pilot Study is to evaluate that multi-organ denervation with the Gemini System is safe and provide evidence of blood pressure reduction when studied in an uncontrolled hypertensive population with…
- Conditions
- Hypertension, Vascular Diseases, Cardiovascular Diseases, Chronic Kidney Diseases
- Trial name
- SPYRAL GEMINI (NCT06907147)
- Testing
- Multi-Organ Denervation Gemini System
- Where
- 18 sites in United States, Australia and 4 more
- Volunteers
- 175 people
- Sponsor
- Medtronic Vascular
Type 1 Diabetes, Type 2 Diabetes
Evaluation of MiniMed Next Generation Extended Wear Sensors and Algorithm in Patients With Type 1 and Type 2 Diabetes
This study will collect sensor data in subjects with T1D or T2D, 2-80 years of age.
- Trial name
- NCT07864168
- Testing
- Next Generation Extended Wear Sensors
- Where
- 18 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Medtronic MiniMed, Inc.
Hypertension, Cardiovascular Diseases
Longitudinal Real-world Clinical Outcomes Study on Symplicity Renal Denervation
This observational study will assess the long-term effectiveness of the RDN procedure for lowering blood pressure in Medicare patients with uncontrolled hypertension.
- Conditions
- Hypertension, Cardiovascular Diseases, Vascular Diseases
- Trial name
- SPYRAL CARE (NCT07174622)
- Testing
- Renal Denervation (Symplicity Spyral™)
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Medtronic Vascular