Clinical trials: sponsored by Medtronic
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
- 6 sites in United States
- Volunteers
- 51 people
- Sponsor
- Medtronic Endovascular
Atrial Flutter, Atrial Fibrillation
Cryoballoon Pulmonary Venous Isolation in Patients Referred for Typical Atrial Flutter Ablation
Background: Atrial fibrillation is frequently associated with typical atrial flutter in clinical practice. If the radical treatment of atrial flutter by radiofrequency catheter is achieved in most cases without recurrence, it…
- Trial name
- PAF CRIOBLAF (NCT01521988)
- Testing
- Atrial flutter ablation, Atrial flutter ablation and pulmonary vein isolation
- Where
- 15 sites in France
- Volunteers
- 76 people
- Sponsor
- University Hospital, Rouen
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
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
- 41 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
- 10 sites in United States, France and 1 more
- Volunteers
- 970 people
- Sponsor
- Medtronic
Left Ventricular Ejection Fraction, Heart Failure (HF)
REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)
Primary Objective - To determine if implantation of a permanent CRT pacing device (with LB-CRT, or conventional BiV-CRT with a coronary sinus LV lead) can improve electromechanical function, HF symptoms, and natriuretic peptide…
- Conditions
- Left Ventricular Ejection Fraction, Heart Failure (HF), Left Bundle-Branch Block
- Trial name
- REINVENT (NCT05652218)
- Testing
- LB-CRT, BIV-CRT
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Inova Health Care Services
Arrhythmia, Bradycardia
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival…
- Conditions
- Arrhythmia, Bradycardia, Heart Failure, Sinus Tachycardia
- Trial name
- PPR (NCT00271180)
- Testing
- Device
- Where
- 338 sites in United States, Australia and 33 more
- Volunteers
- 20,000 people
- Sponsor
- Medtronic
Atrioventricular Block
Biventricular Alternative Pacing
Aim of present study is to examine the short and long-term results of pacing from right ventricular apex and to compare them with those of biventricular pacing.
- Trial name
- BETTER (NCT00559143)
- Testing
- Biventricular Pacing (DDD(R)- BiV)
- Where
- Greece
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cognitive Dysfunction
Cerebral Perfusion in the Beach Chair Position
Surgery to the shoulder may be performed with patients seated upright in a position known as the "Beach Chair Position (BCP)." This position has certain advantages compared to alternative surgical positions (e.g.
- Trial name
- NCT03036345
- Testing
- Dual-monitoring
- Where
- Australia
- Volunteers
- 200 people
- Sponsor
- Brisbane Hand and Upper Limb Research Institute
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
Bladder Cancer, Prostate Cancer
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
This study will evaluate the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.
- Conditions
- Bladder Cancer, Prostate Cancer, Kidney Cancer, Pelvic Tumor
- Trial name
- NCT05696444
- Testing
- RAS Prostatectomy, RAS Cystectomy, RAS Nephrectomy
- Where
- 6 sites in United States
- Volunteers
- 144 people
- Sponsor
- Medtronic - MITG
Heart Failure With Preserved Ejection Fraction (HFpEF)
ELEVATE-HFpEF Clinical Study
ELEVATE-HFpEF is a prospective, randomized, controlled, double-blinded, multi-center, global, interventional pivotal study evaluating the safety and efficacy of dual chamber personalized pacing compared to minimal or no pacing…
- Trial name
- ELEVATE-HFpEF (NCT06678841)
- Testing
- Personalized cardiac pacing
- Where
- 55 sites in United States, Australia and 13 more
- Volunteers
- 700 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Esophagogastric Junction Distensibility, Hiatal Hernia
Esophagogastric Junction Distensibility During Hiatal Hernia Repair
The investigators aim to ascertain the effects of hiatal hernia repair and fundoplication on the distensibility of the esophagogastric junction (EGJ) as measured by FLIP topography/impedance planimetry.
- Trial name
- NCT04450628
- Testing
- EndoFLIP
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Wake Forest University Health Sciences
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
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
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
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
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
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
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