Clinical trials: Symptomatic Aortic Stenosis
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 and Symptomatic Aortic Stenosis, Undergoing TAVI
Vascular Complications and Bleeding After Transfemoral TAVI
Since the first implantation by Cribier, transcatheter aortic valve implantation (TAVI) revolutionized the management of severe symptomatic aortic stenosis.
- Trial name
- NCT03865043
- Where
- France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Montpellier
Hypertrophic Obstructive Cardiomyopathy \(HOCM\)
Myocardial Perfusion Changes Following Optimal Medical Treatment in Symptomatic Hypertrophic Cardiomyopathy
Background: Microvascular dysfunction is a hallmark of hypertrophic obstructive cardiomyopathy (HOCM) and can be visualized non-invasively using cardiac magnetic resonance (CMR) perfusion imaging.
- Trial name
- oHCM (NCT07150299)
- Testing
- Mavacamten in clinical routine use
- Where
- Austria
- Volunteers
- 20 people
- Sponsor
- Medical University of Vienna
Symptomatic Aortic Stenosis, Eligible for Transcatheter Aortic Valve Replacement
Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis
ATLANTIS is a multicenter, phase IIIb, prospective, open-label, randomized trial. The objective of this study is to demonstrate superiority of a strategy of anticoagulation with apixaban (Anti-Xa Group) as compared to the current…
- Trial name
- ATLANTIS (NCT02664649)
- Testing
- Apixaban, Standard of care
- Where
- 4 sites in France, Germany and 2 more
- Volunteers
- 1,510 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Aortic Valve Stenosis
Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction
According to current European Recommendations on valvular heart disease (VHD), "classical" severe aortic stenosis (AS) is defined by an aortic valve area (AVA) ≤1 cm2 and indexed AVA ≤0.6 cm2/m2, a mean aortic pressure gradient…
- Trial name
- ROTAS (NCT03667365)
- Testing
- aortic valve replacement, strict clinical surveillance
- Where
- 18 sites in Belgium, France
- Volunteers
- 52 people
- Sponsor
- Rennes University Hospital
Aortic Stenosis Symptomatic, Aortic Valve Stenosis
Romanian National Registry of Outcomes After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis - RO-TAVI
RO-TAVI is a national prospective, observational, multi-center registry registry of patients with aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI) to assess patient care and outcomes.
- Trial name
- RO-TAVI (NCT04694859)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- Romania
- Volunteers
- 500 people
- Sponsor
- Romanian Society of Cardiology
Aortic Stenosis, Severe
Outcome Prediction in Patients With Aortic Stenosis After TAVI
This study will investigate changes right ventricular function and functional recovery metrics after transcatheter aortic valve implantation
- Trial name
- PREDICT-TAVI (NCT06043180)
- Testing
- Transcatheter aortic valve implantation
- Where
- United Kingdom
- Volunteers
- 69 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Aortic Valve Stenosis
Valvosoft First-In-Human Study in Severe Symptomatic Aortic Stenosis
This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Human
- Trial name
- NCT04665596
- Testing
- Ultrasound treatment
- Where
- Serbia
- Volunteers
- 10 people
- Sponsor
- Cardiawave SA
Symptomatic Aortic Stenosis
Geriatric Evaluation to Predict Mortality and Functional Recovery After Trans Aortic Valve Implantation
Transcutaneous trans-aortic valve replacement (TAVR) is now a common procedure to treat symptomatic aortic stenosis. Although as effective and safe as surgical aortic valve replacement, it is still restricted to high surgical…
- Trial name
- EVA-G-TAVI (NCT02424370)
- Testing
- TAVR
- Where
- France
- Volunteers
- 515 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Symptomatic Aortic Stenosis
Pivotal Study of the Vienna Transcatheter Self Expandable Aortic Valve SE System
This is a prospective, single arm, multicenter study in an cohort of up to 267 patients (up to 100 Roll-ins and 167 patients implanted per protocol) symptomatic patients with severe aortic stenosis who will be followed up for up…
- Trial name
- VIVA (NCT04861805)
- Testing
- Vienna Aortic Valve SE System
- Where
- 31 sites in Argentina, Brazil and 6 more
- Volunteers
- 267 people
- Sponsor
- P+F Products + Features GmbH
Obstructive Hypertrophic Cardiomyopathy
Permanent Pacing for Drug-refractory Symptomatic Patients With Obstructive Hypertrophic Cardiomyopathy.
The present trial is undertaken as a pilot study on selected patients, to evaluate the ability of acute hemodynamic testing to optimize pacing therapy and to predict the response of Obstructive Hypertrophic Cardiomyopathy (OHCM)…
- Trial name
- PACE-OHCM (NCT05771987)
- Testing
- pace maker implant guided by acute hemodynamic testing
- Where
- Italy
- Volunteers
- 10 people
- Sponsor
- Istituto Auxologico Italiano
Cardiomyopathy, Hypertrophic
A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of mavacamten in adolescent patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).
- Trial name
- NCT06253221
- Testing
- Mavacamten
- Where
- 47 sites in United States, Australia and 7 more
- Volunteers
- 44 people
- Sponsor
- Bristol-Myers Squibb
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 Stenosis Disease, Aortic Stenosis Symptomatic
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
he IRON-TAVI trial is a prospective, randomized, multicenter study evaluating whether a multidomain rehabilitation program can improve outcomes in older patients undergoing transcatheter aortic valve implantation for severe…
- Conditions
- Aortic Stenosis Disease, Aortic Stenosis Symptomatic, Aortic Stenosis
- Trial name
- IRON-TAVI (NCT07895719)
- Testing
- Personalized Multidomain Exercise Program, Oral Protein and Iron Nutritional Supplementation, Usual Care
- Where
- Italy
- Volunteers
- 450 people
- Sponsor
- University Hospital of Ferrara
Aortic Stenosis, Symptomatic Aortic Stenosis
Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study
To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.
- Conditions
- Aortic Stenosis, Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification
- Trial name
- DurAVR™ EFS (NCT05712161)
- Testing
- DurAVRTM THV System
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
Symptomatic Aortic Stenosis
Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population
The purpose of this study is to evaluate the safety and effectiveness of transcatheter aortic valve replacement in Chinese population.
- Trial name
- TORCH (NCT02803294)
- Testing
- transcatheter aortic valve replacement
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Symptomatic Severe Aortic Stenosis
FlexNav EU CE Mark Study
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic…
- Trial name
- NCT03724812
- Testing
- Portico Valve and FlexNav™ Delivery System
- Where
- 6 sites in Denmark, Italy and 2 more
- Volunteers
- 46 people
- Sponsor
- Abbott Medical Devices
Heart Valve Diseases, Aortic Valve Stenosis
BIOVALVE - I / II Clincial Investigation
First-in-Human clinical investigation to evaluate the safety and clinical performance of the BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis, which are as judged by the heart team…
- Trial name
- BIOVALVE (NCT02249000)
- Testing
- BIOVALVE prosthesis
- Where
- 13 sites in Belgium, Germany and 2 more
- Volunteers
- 68 people
- Sponsor
- Biotronik AG
Aortic Stenosis Symptomatic
Understanding Patient Goals and Preferences to Facilitate Shared Decision Making for Symptomatic Aortic Stenosis
The overall goal of this study is to develop and validate a preference assessment tool for patients who have severe aortic stenosis and are contemplating their treatment options.
- Trial name
- NCT04755426
- Testing
- AVITA--Aortic Valve Improved Treatment Approaches
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Shared Decision Making Resources
Symptomatic Severe Aortic Stenosis
Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study
Early System Experience with the Abbott Balloon-expandable TAVI System
- Trial name
- EASE (NCT07082426)
- Testing
- Balloon expandable TAVI
- Where
- 3 sites in Georgia, Uzbekistan
- Volunteers
- 8 people
- Sponsor
- Abbott Medical Devices