Clinical trials: Severe Aortic Valve Disease
Aortic Valve Disease, Coronary Artery Disease
Early Outcomes of Concomitant Transcatheter Aortic Valve Implantation and Off-pump Coronary Artery Bypass Grafting in Management of Severe Symptomatic Aortic Stenosis and Coronary Artery Disease
Study Objectives/Specific Aims Overall Goal: To study the outcomes of patients undergoing TAVI, their subsequent results and complications.
- Trial name
- NCT04525339
- Testing
- TAVI and Off pump CABG
- Where
- Egypt
- Volunteers
- 15 people
- Sponsor
- Assiut University
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very 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 high risk for aortic valve surgery and/or…
- Trial name
- NCT01240902
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR)
- Where
- 45 sites in United States
- Volunteers
- 1,453 people
- Sponsor
- Medtronic Cardiovascular
Severe Aortic Stenosis
Safety and Efficacy of SYM-SV/DS-002 in Patients With Severe Aortic Stenosis
Safety and Efficacy of SYM-SV/DS-002 in Patients with Severe Aortic Stenosis
- Trial name
- NCT03004599
- Testing
- SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System
- Where
- 5 sites in Japan
- Volunteers
- 11 people
- Sponsor
- Medico's Hirata Inc.
Aortic Valve Stenosis
The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.
- Trial name
- NCT03471065
- Testing
- SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV
- Where
- 6 sites in Canada, United Kingdom
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis, Coronary Artery Disease
Severe Aortic Valve Stenosis and Concomitant Coronary Artery Disease in Patients Undergoing TAVI
Patients undergoing surgical aortic valve replacement (sAVR) with concomitant coronary artery disease (CAD) are known to have higher mortality rates compared to patients without CAD.
- Trial name
- NCT04385459
- Testing
- Coronary artery disease
- Where
- Sweden
- Volunteers
- 346 people
- Sponsor
- Örebro County Council
Aortic Stenosis, Severe
Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement
This study sought to evaluate the impact of Virtual Reality (VR) tools in procedural planning of transcatheter aortic valve replacement (TAVR).
- Trial name
- NCT04944667
- Testing
- TAVR planning
- Where
- Spain
- Volunteers
- 11 people
- Sponsor
- Centro Medico Teknon
Aortic Stenosis, Aortic Insufficiency
JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation
The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.
- Conditions
- Aortic Stenosis, Aortic Insufficiency, Aortic Regurgitation
- Trial name
- JUPITER (NCT01598844)
- Testing
- Transcatheter aortic valve replacement
- Where
- 15 sites in Germany, Netherlands and 2 more
- Volunteers
- 210 people
- Sponsor
- JenaValve Technology, Inc.
Aortic Valve Stenosis
Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis
The primary objective of the present trial is to demonstrate the safety and effectiveness of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small aortic annuli and deemed difficult for…
- Trial name
- NCT01634269
- Testing
- MDT-2111 TAVI 23 mm
- Where
- 4 sites in Japan
- Volunteers
- 20 people
- Sponsor
- Medtronic Cardiovascular
Hypertrophic Cardiomyopathy
A Comparison of Two Treatments: Pacemaker and Percutaneous Transluminal Septal Ablation for Hypertrophic Cardiomyopathy
This study will compare two treatments: pacemaker implantation and percutaneous transluminal septal ablation (PTSA) for patients with hypertrophic cardiomyopathy (HCM), a condition in which the heart muscle thickens and obstructs…
- Trial name
- NCT00001894
- Testing
- pacemaker implantation, percutaneous transluminal septal ablation (PTSA)
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Severe Aortic Valve Stenosis
The Use of ACURATE Neo 2 Valve in Patients With Symptomatic Aortic Valve Stenosis
The objective of this study is to evaluate the ACURATE Neo2 in the Middle East population with severe, symptomatic aortic stenosis.
- Trial name
- BSC07 (NCT05847751)
- Testing
- Aortic valve replacement
- Where
- 7 sites in Egypt, Lebanon and 1 more
- Volunteers
- 51 people
- Sponsor
- Ceric Sàrl
Severe Aortic Valve Stenosis
In-vitro Benchmarking of Currently Available Heart Valve Prostheses for Surgical and Percutaneous Treatment of Aortic Stenosis With Small Annulus, Followed by In-vivo Validation
The general objective of this study is to compare in vitro and in vivo the hemodynamic performance of different types of aortic valve prostheses and possible surgical implantation techniques.
- Trial name
- SurPASS (NCT06859255)
- Testing
- MRI
- Where
- 2 sites in Italy
- Volunteers
- 200 people
- Sponsor
- IRCCS Policlinico S. Donato
Aortic Valve Stenosis, Malignancy
Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis
As for today, transcatheter aortic valve implantation (TAVI) is indicated only in symptomatic patients with severe aortic stenosis (AS) at high surgical risk.
- Trial name
- TOP-AS (NCT03181997)
- Testing
- Native aortic valve, Transcatheter aortic valve implantation (TAVI)
- Where
- Israel
- Volunteers
- 168 people
- Sponsor
- Rabin Medical Center
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
Aortic Stenosis, Severe
China S3 PMS: SAPIEN 3 China Post Market Registry Study
The objective of this study is to evaluate the long term safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve system in real world setting.
- Trial name
- NCT05168826
- Testing
- SAPIEN 3 Transcatheter Heart Valve
- Where
- 14 sites in China
- Volunteers
- 250 people
- Sponsor
- Edwards Lifesciences
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
DurAVR™ THV System: EMBARK Study
A prospective, non-randomized, single-arm, single-center, first-in-human study designed to evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe aortic stenosis.
- Conditions
- Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification
- Trial name
- NCT05182307
- Testing
- DurAVR™ THV System
- Where
- Georgia
- Volunteers
- 150 people
- Sponsor
- Anteris Technologies Ltd.
Severe Aortic Stenosis, Transcatheter Aortic Valve Implantation
Primary Non-invasive Cardiac Computed Tomography Versus Routine Invasive Angiography Prior to TAVI
This pilot study is a prospective, randomized, open-label trial that aims to assess the feasibility of comparing a primary Computed tomography/Cardiac computed tomography angiography (CT/CCTA) strategy (test arm) to a strategy…
- Trial name
- CT-CA (NCT03291925)
- Testing
- Selective invasive angiography based on CT/CCTA imaging., Procedure/Surgery: Invasive angiography
- Where
- Canada
- Volunteers
- 200 people
- Sponsor
- BC Centre for Improved Cardiovascular Health
Severe Aortic Valve Stenosis
Multi Center Registry of Transcatheter Aortic Valve Replacement in Northeast China
The purpose of this study was to observe the safety and effectiveness of transcatheter aortic valve replacement in patients with aortic valve stenosis in a real-world clinical practice environment.
- Trial name
- NCT04988243
- Testing
- All aortic valve products on the market
- Volunteers
- 320 people
- Sponsor
- CCRF Inc., Beijing, China
Symptomatic Severe Aortic Stenosis
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic…
- Trial name
- PII A (NCT01314313)
- Testing
- TAVR Implantation with SAPIEN XT, SAVR Implantation
- Where
- 57 sites in United States, Canada
- Volunteers
- 2,032 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis
TAVI is still a relatively new technique that is emerging with advance in the percutaneous and implantable valve technology. Despite its safe use in inoperable and high risk patients with severe symptomatic aortic valve stenosis…
- Trial name
- TAVI (NCT03633383)
- Testing
- Transcatheter aortic valve
- Volunteers
- 50 people
- Sponsor
- Assiut University
Aortic Valve Stenosis
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for…
- Trial name
- NCT03517436
- Testing
- TAVR with CENTERA THV
- Where
- 23 sites in United States
- Volunteers
- 101 people
- Sponsor
- Edwards Lifesciences