Clinical trials: sponsored by Medtronic Cardiovascular
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
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 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
Mitral Valve Insufficiency
Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System
PILOT: The study is a pilot trial to evaluate the safety and performance of the Twelve TMVR System in high risk mitral regurgitation patients.
- Trial name
- NCT02322840
- Testing
- Twelve TMVR Implant, Medtronic Intrepid™ Transcatheter Transfemoral Mitral Valve Replacement System
- Where
- 32 sites in United States, Australia and 5 more
- Volunteers
- 128 people
- Sponsor
- Medtronic Cardiovascular
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
Severe, Symptomatic Aortic Stenosis
Evolut PRO China Clinical Study
Interventional study to evaluate the safety and efficacy of the Medtronic CoreValve™ Evolut™ PRO System when used by China implanting centers in Chinese patients with severe symptomatic aortic stenosis (AS) who are at high risk…
- Trial name
- NCT04982588
- Testing
- Medtronic CoreValve™ Evolut™ PRO System
- Where
- 4 sites in China
- Volunteers
- 52 people
- Sponsor
- Medtronic Cardiovascular
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
Aortic Aneurysm, Thoracic
Valiant Evo International Clinical Trial
The purpose of the Valiant Evo International Clinical Trial is to demonstrate the safety and effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending thoracic aortic aneurysm (DTAA) who are…
- Trial name
- NCT02625324
- Testing
- Valiant Evo Thoracic Stent Graft System
- Where
- 16 sites in Canada, Denmark and 4 more
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiovascular
Aortic Aneurysm, Thoracic
Valiant Evo US Clinical Trial
The purpose of the Valiant Evo US Clinical Trial is to demonstrate the safety and effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending thoracic aortic aneurysm (DTAA) who are candidates for…
- Trial name
- VEVO (NCT02652949)
- Testing
- Valiant Evo Thoracic Stent Graft System
- Where
- 21 sites in United States
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiovascular
Abdominal Aortic Aneurysm, AAA
Endurant Evo International Clinical Trial
The purpose of this trial is to evaluate the safety and effectiveness of the Endurant Evo Abdominal Aortic Aneurysm (AAA) Stent graft system for endovascular treatment of subjects with infrarenal abdominal aortic or aortoiliac…
- Trial name
- NCT02461524
- Testing
- Endurant Evo AAA Stent Graft System, Endovascular aneurysm repair (EVAR)
- Where
- 9 sites in Austria, Belgium and 3 more
- Volunteers
- 69 people
- Sponsor
- Medtronic Cardiovascular
Congenital Heart Defects, Dysfunctional Right Ventricular Outflow Tract Conduits
Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort
The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review.
- Trial name
- NCT00740870
- Testing
- Transcatheter Pulmonary Valve replacement
- Where
- 5 sites in United States
- Volunteers
- 171 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Stenosis
Medtronic Evolut™ EXPAND TAVR I Feasibility Study
The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.
- Trial name
- NCT04639258
- Testing
- Medtronic Evolut™ PRO+ System
- Where
- 8 sites in United States, Australia and 3 more
- Volunteers
- 11 people
- Sponsor
- Medtronic Cardiovascular
Aortic Aneurysm, Thoracic
VALIANT CAPTIVIA Post-market Registry
The Valiant Thoracic Stent Graft has been preloaded on the new Captivia Delivery System (Captivia). This new delivery system was CE marked on September 14th, 2009 and was commercially released in the European Union on October…
- Trial name
- VCOUS (NCT01181947)
- Testing
- TEVAR
- Where
- 15 sites in Austria, Germany and 5 more
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiovascular
Thoracic Aortic Aneurysms
Safety and Efficacy of Valiant Mona LSA Stent Graft System
The Valiant Mona LSA thoracic stent graft system is for the endovascular repair of aneurysms of the descending thoracic aorta (DTA) in patients who require coverage of the left subclavian artery (LSA).The study is intended to…
- Trial name
- NCT01839695
- Testing
- Valiant Mona LSA Stent Graft System
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 9 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Stenosis
Medtronic CoreValve Evolut R U.S. Clinical Study (Evolut 34R Addendum)
The study objectives are to assess the safety and efficacy of the CoreValve Evolut 34R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis who are considered at high or extreme…
- Trial name
- NCT02746809
- Testing
- CoreValve Evolut 34R TAVR system
- Where
- 10 sites in United States
- Volunteers
- 72 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Stenosis
The Medtronic TAVR 2.0 US Clinical Study
The study objective is to evaluate safety and efficacy of the Medtronic TAVR (Transcatheter Aortic Valve Replacement) 2.0 system in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk…
- Trial name
- NCT02738853
- Testing
- Medtronic Transcatheter Aortic Valve 2.0 Replacement System
- Where
- 8 sites in United States
- Volunteers
- 93 people
- Sponsor
- Medtronic Cardiovascular
Abdominal Aortic Aneurysm, AAA
Endurant Evo US Clinical Trial
The purpose of this study is to demonstrate that the Endurant Evo Abdominal Aortic Aneurysm (AAA) stent graft system is safe and effective for endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms.
- Trial name
- NCT02393716
- Testing
- Endurant Evo AAA Stent Graft System, Endovascular aneurysm repair (EVAR)
- Where
- 14 sites in United States
- Volunteers
- 139 people
- Sponsor
- Medtronic Cardiovascular
Aortic Stenosis
Medtronic CoreValve Evolut R U.S. Clinical Study
The study objectives are to assess the safety and efficacy of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis are considered at high or extreme risk…
- Trial name
- NCT02207569
- Testing
- CoreValve Evolut R TAVR system
- Where
- 23 sites in United States
- Volunteers
- 241 people
- Sponsor
- Medtronic Cardiovascular
Severe Aortic Stenosis
Safety and Efficacy Continued Access Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in Very High Risk Subjects and High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted very high risk and high risk for aortic…
- Trial name
- NCT01531374
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 45 sites in United States
- Volunteers
- 2,777 people
- Sponsor
- Medtronic Cardiovascular