Clinical trials: completed, 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
Intervertebral Disc Degeneration
5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures to Treat Degenerative Lumbar Spine (MASTERS-D2)
The purpose of this study is to evaluate the effectiveness of MAST techniques for anterior/lateral and posterior approaches in Degenerative Disc Disease (DDD) patients with spondylolisthesis (≥ grade I).
- Trial name
- MASTERS-D2 (NCT02617563)
- Testing
- Minimally invasive lumbar fusion
- Where
- 27 sites in Argentina, Austria and 15 more
- Volunteers
- 361 people
- Sponsor
- Medtronic Spinal and Biologics
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
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
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
Renal Disease, End Stage, Kidney Disease, End-Stage
Ellipsys Vascular Access System Post Market Surveillance (PS) Study
The proposed clinical study is a prospective, non-randomized, multi-center, single-arm, observational, post-market surveillance (PS) study of the Ellipsys Vascular Access System in subjects eligible for arteriovenous (AV) fistula.
- Conditions
- Renal Disease, End Stage, Kidney Disease, End-Stage, AV Fistula, Fistulas Arteriovenous
- Trial name
- NCT04484220
- Testing
- Ellipsys Vascular Access System
- Where
- 12 sites in United States
- Volunteers
- 142 people
- Sponsor
- Medtronic Endovascular
Type 2 Diabetes Treated With Insulin
In-Home Study With MiniMed™ 780G Pump Automated Control in Type 2-Evaluation of the AHCL System in Adults With Insulin-requiring Type 2 Diabetes
The objective of the study is to assess the safety and effectiveness of MiniMed™ 780G system in adult subjects with insulin-requiring type 2 diabetes in a home setting.
- Trial name
- NCT05238142
- Testing
- MiniMed™ 780G Insulin Pump system
- Where
- 31 sites in United States
- Volunteers
- 574 people
- Sponsor
- Medtronic MiniMed, Inc.
Symptomatic Paroxysmal Atrial Fibrillation (PAF)
FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation
Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with paroxysmal atrial fibrillation.
- Trial name
- NCT01490814
- Testing
- Electrical isolation of the pulmonary veins, Electrical isolation of pulmonary veins
- Where
- 19 sites in Czechia, France and 6 more
- Volunteers
- 769 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Bradycardia, Tachycardia
China 3T MRI Study
The purpose of the China CIED 3.0T MRI Performance Study is to confirm safety of SureScan CIED in the clinical 3.0T MRI environment when subjects receive MRI scans.
- Conditions
- Bradycardia, Tachycardia, Heart Failure
- Trial name
- NCT06038123
- Testing
- China market released 3.0T Magnetic resonance (MR) conditional CIED systems
- Where
- 5 sites in China
- Volunteers
- 64 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Persistent Atrial Fibrillation, Atrial Fibrillation
DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation
The purpose of the Diamond-AF II study is to establish the safety and effectiveness of the DiamondTemp Ablation System for the treatment of drug refractory, symptomatic persistent atrial fibrillation in patients.
- Trial name
- Diamond-AFII (NCT03643224)
- Testing
- Radiofrequency Ablation
- Where
- 28 sites in United States, Canada and 4 more
- Volunteers
- 376 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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
Tachycardia, Ventricular Arrythmia
ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
The study is designed to characterize the acute safety and performance of the EV ICD System for Japanese patients.
- Trial name
- NCT07091916
- Testing
- Defibrillation using the Extravascular ICD
- Where
- Japan
- Volunteers
- 14 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.
Aortic Aneurysm, Thoracic, Chronic Type B Dissection
Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending TAA and Chronic Dissections
The purpose of the Feasibility study is to characterize the safety of the Valiant Mona LSA Thoracic Stent Graft System, including an assessment of the safety and effectiveness of the device acutely and at the 30 day visit in the…
- Trial name
- NCT02365467
- Testing
- Valiant Mona LSA Thoracic Stent Graft System
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Medtronic Cardiovascular
Syncope
ISSUE3: International Study on Syncope of Uncertain Etiology 3
ISSUE 3 is a multi-center, prospective, randomised controlled double-blind study aimed to assess the effectiveness of pacemaker therapy for prevention of asystolic neurally-mediated syncope.
- Trial name
- NCT00359203
- Testing
- Dual chamber pacemeker
- Where
- Italy
- Volunteers
- 511 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Leadless Electrocardiogram (ECG) Evaluation Study
The leadless electrocardiogram (LECG) is a new technology incorporated into the Consulta CRT-P to obtain an ECG signal from the Consulta CRT-P similar to a surface ECG obtained from the device programmer (PECG) or an external ECG…
- Trial name
- LECG (NCT01297283)
- Testing
- LECG first, Programmer ECG first
- Where
- France
- Volunteers
- 195 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tachycardia, Ventricular, Ventricular Fibrillation
ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
The purpose of this study is to estimate and quantify the difference in efficacy of two sequences of ATP therapies (burst 15 pulses, 88% versus burst 8 pulses, 88%) during an episode of spontaneous rhythms classified as fast…
- Trial name
- ADVANCE_D (NCT00147277)
- Testing
- Implantable Cardiac Defibrillator
- Where
- Italy
- Volunteers
- 925 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Left Bundle-Branch Block
Mid-Q Response Study
The Mid-Q Response study is a prospective, multi-center, randomized controlled, interventional, single-blinded, post-market study.
- Conditions
- Heart Failure, Left Bundle-Branch Block, Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure NYHA Class II
- Trial name
- NCT04180696
- Testing
- aCRT ON, aCRT OFF
- Where
- 61 sites in Brunei, China and 8 more
- Volunteers
- 177 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure