Clinical trials: sponsored by 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
Hemorrhoid, Hemorrhoid Bleeding
Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment
BRIGHT is a Europe-wide study that will follow up to 250 adults with bleeding symptoms from haemmorhoids (Grade II-III categories).
- Trial name
- BRIGHT (NCT07264413)
- Testing
- Haemorrhoid artery embolizsation (HAE)
- Volunteers
- 250 people
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe
Tricuspid Regurgitation
TTVR Early Feasibility Study
The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a…
- Trial name
- NCT04433065
- Testing
- Intrepid™ TTVR System
- Where
- 20 sites in United States
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiovascular
Congenital Heart Disease, Tetrology of Fallot
Harmony TPV Post-Approval Study
The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.
- Conditions
- Congenital Heart Disease, Tetrology of Fallot, RVOT Anomaly, Pulmonary Regurgitation
- Trial name
- NCT05077774
- Testing
- Harmony TPV System
- Where
- 20 sites in United States, Canada
- Volunteers
- 174 people
- Sponsor
- Medtronic Cardiovascular
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
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
Moderate or Severe Aortic Stenosis
Sparrow App Guided Evaluation (SAGE) Vanguard Trial for Aortic Stenosis in Adults Aged Seventy and Older
The purpose of this research is to look at an approved intervention (Stethophone application) to obtain additional information about improving detection of moderate or severe aortic stenosis when compared with usual standard of…
- Trial name
- SAGE-AS (NCT07828730)
- Testing
- Stethophone
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Sunnybrook Health Sciences Centre
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
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
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder)
Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial
The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal…
- Conditions
- Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder), Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder)
- Trial name
- ADVANCE (NCT05378347)
- Testing
- Medtronic Endurant II or Endurant IIs Stent Graft System, Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis
- Where
- 68 sites in United States, Finland and 10 more
- Volunteers
- 600 people
- Sponsor
- Medtronic Cardiovascular
Coronary Artery Disease, Arterial Occlusive Diseases
IRIS-Onyx Cohort in the IRIS-DES Registry
The purpose of this study is to evaluate the relative effectiveness and safety of Onyx stent compared to other (drug eluting stents) DES.
- Conditions
- Coronary Artery Disease, Arterial Occlusive Diseases, Cardiovascular Diseases, Percutaneous Transluminal Angioplasty
- Trial name
- IRIS-Onyx (NCT02593994)
- Testing
- Onyx Drug Eluting Stent group
- Where
- 31 sites in South Korea
- Volunteers
- 4,500 people
- Sponsor
- Seung-Jung Park
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients…
- Trial name
- SURTAVI (NCT01586910)
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR), Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 86 sites in United States, Canada and 7 more
- Volunteers
- 1,746 people
- Sponsor
- Medtronic Cardiovascular
AAA - Abdominal Aortic Aneurysm
Endurant CHevAr New Indication Trial: ENCHANT
The purpose of the post-market study is to assess the clinical outcomes, safety, and performance of the Endurant Chimney Graft Technique (Endurant Stent Graft Systems used with a balloon-expandable covered stent graft) for…
- Trial name
- ENCHANT (NCT03320252)
- Testing
- Endurant Chimney Graft Technique
- Where
- 26 sites in Austria, France and 11 more
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiovascular
Symptomatic Aortic Stenosis, Aortic Valve Stenosis
SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic…
- Conditions
- Symptomatic Aortic Stenosis, Aortic Valve Stenosis, Aortic Valve Replacement
- Trial name
- SMART (NCT04722250)
- Testing
- Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems, Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
- Where
- 92 sites in United States, Canada and 11 more
- Volunteers
- 1,103 people
- Sponsor
- Medtronic Cardiovascular
Aortic Aneurysm, Abdominal
ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES
The aim of this randomized study is to compare the safety and performance of EndoVascular Aneurysm Repair with ESAR using Endurant + Heli-FX™ EndoAnchor™ system and FEVAR using customizable grafts from Cook (Zenith Fenestrated…
- Trial name
- SOCRATES (NCT04503395)
- Testing
- ESAR treatment: Endograft + Heli-FX Endoanchor, FEVAR treatment : Fenestrated endograft
- Where
- 33 sites in United States, Austria and 8 more
- Volunteers
- 204 people
- Sponsor
- FCRE (Foundation for Cardiovascular Research and Education)
Colorectal Neoplasms Malignant, Neoplasm Metastasis
CIRSE Emprint Microwave Ablation Registry
Observation of the clinical use of the Emprint Microwave Ablation System for the ablation of Liver Metastases of Colorectal Adenocarcinoma.
- Trial name
- CIEMAR (NCT03775980)
- Testing
- Emprint Microwave Ablation System
- Where
- 38 sites in Croatia, Denmark and 11 more
- Volunteers
- 500 people
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe
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
Bicuspid Aortic Valve
Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study
The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR
- Trial name
- NCT03635424
- Testing
- Medtronic TAVR Systems
- Where
- 25 sites in United States
- Volunteers
- 150 people
- Sponsor
- Medtronic Cardiovascular