Clinical trials: Transcatheter Valve Replacement
Transcatheter Aortic Valve Implantation (TAVI), Aortic Valve Stenosis
Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)
The purpose of this study is to assess the feasibility and safety of the Transverse Medical, Inc. Point-Guard device. This feasibility study is a limited clinical investigation of the Point-Guard device.
- Conditions
- Transcatheter Aortic Valve Implantation (TAVI), Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
- Trial name
- GUARDIAN (NCT06962371)
- Testing
- cerebral embolic protection
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- Transverse Medical, Inc.
Transcatheter Aortic Valve Replacement
Short Versus Long Antiplatelet Therapy After TAVI
The goal of this clinical trial is to learn if reducing the duration of treatment by aspirin to 3 months (short treatment regimen) after percutaneous aortic valve replacement is as safe and efficient as the routine lifetime…
- Trial name
- SOLOTAVI (NCT06518317)
- Testing
- Aspirin
- Where
- France
- Volunteers
- 1,400 people
- Sponsor
- University Hospital, Caen
Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implantation
TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics
The aim of this clinical study is to learn more about the effects of TAVR-prosthesis positioning on hemodynamics and the coronary arteries. The main questions it aims to answer are: 1.
- Conditions
- Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve Implantation, Commissural Alignment, Commissural Misalignment
- Trial name
- NCT06896227
- Testing
- transthoracic echocardiography
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Heinrich-Heine University, Duesseldorf
Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure
The ShortCut™ Study Protocol
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets in patients who are presented…
- Trial name
- NCT04952909
- Testing
- ShortCut™
- Where
- 23 sites in United States, France and 3 more
- Volunteers
- 60 people
- Sponsor
- Pi-cardia
Aortic Stenosis, Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve Replacement (TAVR) Effects on Cardiac Conduction System
This is a prospective observational study, the purpose of which is to: 1. Characterize response of the AV conduction system to TAVR with various prostheses by recording continuous His bundle electrograms during valve placement.
- Conditions
- Aortic Stenosis, Transcatheter Aortic Valve Replacement, Heart Block
- Trial name
- TAVR-HBE (NCT04982406)
- Testing
- Transcatheter aortic valve replacement
- Where
- United States
- Volunteers
- 409 people
- Sponsor
- Beth Israel Deaconess Medical Center
Aortic Valve Disease Mixed, Transcatheter Aortic Valve Replacement
Feasibility of Valve-in-Root Transcatheter Aortic Valve Implantation in 363 Patients After Aortic Root Replacement and Repair
Biological replacement of the aortic valve in the sense of a complete root replacement is the therapy for a dilatation or aneurysm of the ascending aorta, which also involves the aortic valve.
- Trial name
- Valve in Root (NCT06697249)
- Testing
- Analysis of postoperative CT scans checking for the feasibility of transcatheter valve-in-root implantation
- Where
- Germany
- Volunteers
- 760 people
- Sponsor
- Alicja Zientara
Transcatheter Aortic Valve Replacement
Anticoagulation Alone Versus Anticoagulation and Aspirin Following Transcatheter Aortic Valve Interventions (1:1)
The main objective of this study is to demonstrate that a single anticoagulant therapy is superior to a combination of anticoagulant and antiplatelet therapy on the net clinical benefit estimated at 12 months after a…
- Trial name
- AVATAR (NCT02735902)
- Testing
- Vitamin K antagonist or direct oral anticoagulant treatment, Aspirin
- Where
- 6 sites in France
- Volunteers
- 170 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Aortic Stenosis, Transcatheter Aortic Valve Implantation
Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
The goal of the NEO2 BAV registry is to investigate the safety, effectiveness, and clinical performance of TAVI using the ACURATE neo2 valve in patients with severe BAV stenosis.
- Conditions
- Aortic Stenosis, Transcatheter Aortic Valve Implantation, Bicuspid Aortic Valve, Transcatheter Aortic Valve Replacement
- Trial name
- Neo2BAV (NCT06212050)
- Testing
- Transcatheter Aortic Valve Implantation
- Where
- 3 sites in Germany, Ireland and 1 more
- Volunteers
- 200 people
- Sponsor
- National University of Ireland, Galway, Ireland
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Aortic Stenosis With COmplex PCI (ASCOP) Features Retrospective Registry on Contemporary Management and Outcomes
To describe the prevalence and clinical features of patients with severe aortic stenosis undergoing TAVI and concomitant clinically indicated, complex and/or high-risk PCI
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement, Angioplasty, Balloon, Coronary, Coronary Artery Disease
- Trial name
- ASCOP (NCT05750927)
- Testing
- Transcatheter aortic valve intervention (TAVI) and percutaneous coronary intervention (PCI)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Niguarda Hospital
Coronary Artery Bypass Grafting, Heart Valve Replacement
A Prehabilitation Program for Frail Patients Undergoing Cardiac Surgeries/Procedures
The purpose of this study is to develop and evaluate a frailty-specific prehabilitation program for patients awaiting cardiac surgeries/procedures.
- Conditions
- Coronary Artery Bypass Grafting, Heart Valve Replacement, Transcatheter Aortic Valve Implantation, Frailty
- Trial name
- PREHAB (NCT06323317)
- Testing
- Multi-component exercise programme, Structured preoperative education, Nutritional optimization
- Where
- Hong Kong
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- The University of Hong Kong
Aortic Stenosis, Transcatheter Aortic Valve Replacement
EffecTAVI Registry
Aortic stenosis (AS) is the most common valvular heart disease among elderly population, with a increasing prevalence due to population ageing.
- Conditions
- Aortic Stenosis, Transcatheter Aortic Valve Replacement, TAVI
- Trial name
- NCT05235555
- Testing
- Transcatheter heart valve (THV) with CE approval
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- Federico II University
Transcatheter Aortic Valve Replacement, Hemodynamic Monitoring
Assessment of Paravalvular Leak After TAVI by Hemodynamic Measurements and Cardiac MRI
Rationale: Transcatheter aortic valve implantation (TAVI) has become the standard therapy for elderly patients with high surgical risks.
- Conditions
- Transcatheter Aortic Valve Replacement, Hemodynamic Monitoring, Aortic Valve Insufficiency, Aortic Valve Stenosis
- Trial name
- APPOSE (NCT04281771)
- Testing
- cardiac MRI
- Where
- Netherlands
- Volunteers
- 92 people
- Sponsor
- Radboud University Medical Center
Coronary Angiography, Transcatheter Aortic Valve Replacement
Coronary Access After Supra-Annular THV Implantation
To determine the optimal technique and equipment for selective coronary engagement specifically following Evolut THV implantation using commissural alignment.
- Trial name
- CAN-ACCESS (NCT05075590)
- Testing
- Coronary Angiography
- Where
- 4 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- University of British Columbia
Transcatheter Aortic Valve Replacement, Antithrombotic Therapy
Antithrombotic Strategy Based on Clinical Events and 4D-CT for Patients After TAVR
This is a multicenter, open-label, randomized controlled study meant to test the superior efficacy of oral anticoagulation (OAC) therapy versus single antiplatelet therapy (SAPT) in patients after TAVR.
- Conditions
- Transcatheter Aortic Valve Replacement, Antithrombotic Therapy, Bioprosthetic Valve Thrombosis
- Trial name
- NCT05375474
- Testing
- Oral anticoagulation therapy, Single antiplatelet therapy
- Where
- China
- Volunteers
- 650 people
- Sponsor
- China National Center for Cardiovascular Diseases
Postoperative Delirium, Postoperative Cognitive Dysfunction
Cognitive Outcome After Surgical and Transcatheter Aortic Valve Replacement
Aortic valve stenosis is one of the most common types of heart disease in the aging Western population. While surgical cardiac valve replacement (SAVR) is a standard therapy for patients with aortic stenosis, catheter-assisted…
- Conditions
- Postoperative Delirium, Postoperative Cognitive Dysfunction, Transcatheter Aortic Valve Replacement, Surgical Aortic Valve Replacement
- Trial name
- COSTA (NCT04535076)
- Testing
- Transcatheter Aortic Valve Implantation, Surgical Aortic Valve Replacement
- Where
- Germany
- Volunteers
- 31 people
- Sponsor
- Heart and Brain Research Group, Germany
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
The JUMPSTART Program: Encouraging Early Mobilization and Optimizing Recovery of TAVR Patients' Post-hospital Discharge
A virtual, self-directed, and tailored early mobilization program called JUMPSTART, that aims to bridge cardiac rehabilitation intake for post-TAVR patients has been developed at the Hamilton General Hospital.
- Trial name
- NCT06040398
- Testing
- JUMPSTART exercise program
- Where
- Canada
- Volunteers
- 150 people
- Sponsor
- Hamilton Health Sciences Corporation
Transcatheter Aortic Valve Replacement
Post-TAVI Coronary Access Study
Coronary access after trans-catheter aortic valve implantation (TAVI) remains a major challenge. With the evolution of TAVI procedure and the inclusion of lower-risk patients with aortic stenosis, future coronary access is an…
- Trial name
- PTCA (NCT04649190)
- Testing
- TAVI
- Where
- Israel
- Volunteers
- 200 people
- Sponsor
- Sheba Medical Center
Transcatheter Aortic Valve Replacement, Aortic Regurgitation
TAVR in Adults With Pure Severe Aortic Regurgitation
The study aimed to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in patients with severe native valve aortic insufficiency. It is a multicentre, observational cohort study.
- Trial name
- SENSE-AR (NCT05737264)
- Where
- China
- Volunteers
- 76 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Transcatheter Aortic Valve Replacement, Procedural Sedation
Comparison of Procedural Sedation With Propofol and Dexmedetomidine During Transcatheter Aortic Valve Implantation
Aortic valve stenosis is the most common valvular heart disease in the developed world, affecting 3,9% of population over 70 years of age.
- Trial name
- NCT03747432
- Testing
- Propofol, Dexmedetomidine
- Where
- Slovenia
- Volunteers
- 70 people
- Sponsor
- University Medical Centre Ljubljana
Aortic Valve Stenosis, Valsartan
Efficacy of Angiotensin Receptor Blocker Following aortIc Valve Intervention for Aortic STenOsis: a Randomized mulTi-cEntric Double-blind Phase II Study
Aortic stenosis (AS) is the most frequent valvular heart disease in Western countries, with increasing prevalence. Recent guidelines recommend aortic valve intervention (surgical aortic valve replacement [SAVR] or transcatheter…
- Conditions
- Aortic Valve Stenosis, Valsartan, Angiotensin Receptor Antagonists, Transcatheter Aortic Valve Replacement
- Trial name
- ARISTOTE (NCT03315832)
- Testing
- Valsartan
- Where
- France
- Sponsor
- University Hospital, Limoges