Clinical trials: Aortic Stenosis, Severe
Ischemic Heart Disease, Aortic Stenosis, Severe
Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients
The goal of this interventional is to assess advantages of the ultrasound examination of the lungs in the early postoperative period in cardiac surgical patients after heart surgeries requiring cardiopulmonary bypass.
- Conditions
- Ischemic Heart Disease, Aortic Stenosis, Severe, Aortic Insufficiency, Mitral Stenosis
- Trial name
- NCT06377449
- Testing
- Ultrasound examination of the lungs
- Where
- Russia
- Volunteers
- 186 people
- Sponsor
- Saint Petersburg State University, Russia
Aortic Stenosis Symptomatic
ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2011-03)
First-In-Man Study on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human feasibility data pertaining to the safety and performance of the device.
- Trial name
- 2011-03 (NCT03752996)
- Testing
- ACURATE TF™ Aortic Valve System
- Where
- 5 sites in Brazil, Germany
- Volunteers
- 140 people
- Sponsor
- Symetis SA
Aortic Valve Stenosis
Valvosoft First-In-Man 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-man
- Trial name
- NCT03779620
- Testing
- Ultrasound treatment of Calcified aortic valve
- Where
- 2 sites in France, Netherlands
- Volunteers
- 30 people
- Sponsor
- Cardiawave SA
TAVI
PRELOAD-TAVI Trial
The aim is to assess the response of cardiac output and stroke volume to volume preload optimization in patients with severe aortic stenosis treated with aortic prosthesis implantation.
- Trial name
- PRELOAD-TAVI (NCT05914051)
- Testing
- Colloid preload
- Volunteers
- 50 people
- Sponsor
- Fundación de investigación HM
Aortic Stenosis, Left Ventricular Function Systolic Dysfunction
Transcatheter Aortic Valve Implantation Without Predilation
The purpose of this study is to demonstrate that the avoidance of balloon valvuloplasty for predilation of the native aortic valve is associated with a reduction of the composite primary endpoint in TAVI patients with severely…
- Conditions
- Aortic Stenosis, Left Ventricular Function Systolic Dysfunction, High-risk Patients, Transcatheter Aortic Valve Implantation
- Trial name
- SIMPLIFy TAVI (NCT01539746)
- Testing
- TAVI without BAV, TAVI standard procedure
- Where
- 6 sites in Germany
- Volunteers
- 110 people
- Sponsor
- University Hospital, Bonn
Severe Aortic Stenosis
Coronary Access After Evolut FX Plus TAVI: Impact of Commissural Alignment and the Large-Cell Frame Design: ACCESS-FX+ Registry
The ACCESS-FX+ Registry is a prospective, multicenter, single-arm study designed to evaluate the feasibility of coronary access after transcatheter aortic valve implantation (TAVI) using the Evolut FX Plus transcatheter heart…
- Trial name
- NCT07813273
- Volunteers
- 122 people
- Sponsor
- Yonsei University
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
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)
Symptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative…
- Trial name
- NCT03752866
- Testing
- Portico™ Valve, Portico Delivery System(s) and Loading System(s), Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)
- Where
- 28 sites in Australia, Belgium and 7 more
- Volunteers
- 1,001 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis
Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis
The optimal timing of surgical intervention remains controversial in asymptomatic patients with very severe aortic stenosis. The investigators therefore try to compare long-term clinical outcomes of early surgery with those of…
- Trial name
- RECOVERY (NCT01161732)
- Testing
- Early surgery
- Where
- 4 sites in South Korea
- Volunteers
- 145 people
- Sponsor
- Asan Medical Center
Severe and Symptomatic Aortic Stenosis, Stable Coronary Disease
Post TAVI Coronary REVASCularisation Guided by Myocardial Perfusion Imaging: a Prospective Open Label Pilot Study: The REVASC-TAVI Study
Evaluation of a strategy of selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging.
- Trial name
- REVASC-TAVI (NCT02797158)
- Testing
- TAVI procedure
- Where
- France
- Volunteers
- 71 people
- Sponsor
- University Hospital, Montpellier
Aortic Stenosis
Biological Factors Associated With Subclinical Valvular Thrombosis
A prospective, multicentric cohort study including 166 patients with symptomatic aortic stenosis treated with transcatheter aortic valve implantation (TAVI).
- Trial name
- START (NCT03847948)
- Testing
- CT SCAN
- Where
- 2 sites in Spain
- Volunteers
- 166 people
- Sponsor
- Hospital San Carlos, Madrid
Prosthesis Survival, Prosthesis; Cardiac, Heart, Functional Disturbance as Result
Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement
The mechanical intervention is treating aortic valve stenosis (AVS) which may be performed using the standard open surgical approach for aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI).
- Trial name
- TAVISAR (NCT05261204)
- Testing
- Transcatheter Aortic Valve Implantation, Bioprothesis, Sutureless
- Where
- France
- Volunteers
- 4,000 people
- Sponsor
- Centre Cardiologique du Nord
Severe Aortic Valve Stenosis
Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Reduce Thromboembolic and Bleeding Events in Non-atrial Fibrillation Patients After Transcatheter Aortic Valve Implantation
The POPular ATLANTIS trial aims to investigate CT-guided antithrombotic therapy compared to lifelong single antiplatelet therapy after a transcatheter aortic valve implantation (TAVI) procedure.
- Trial name
- POP ATLANTIS (NCT06168370)
- Testing
- CT guided strategy
- Where
- Netherlands
- Volunteers
- 2,500 people
- Sponsor
- St. Antonius Hospital
Transcatheter Aortic Valve Implantation
Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis
The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System.
- Trial name
- EMPIRE (NCT05478161)
- Testing
- (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 11 sites in Germany, Netherlands and 1 more
- Volunteers
- 137 people
- Sponsor
- NVT GmbH
Bradycardia
Conduction Abnormalities With Severe Aortic Stenosis Before and After Transcatheter Aortic Valve Replacement
Most of the conduction abnormalities with TAVR are usually detected during the procedure or during the following days of observation.
- Trial name
- NCT03180073
- Testing
- Ziopatch Pre discharge, Ziopatch at Discharge, Ziopatch at 2 months
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- The Cleveland Clinic
Aortic Valve Stenosis, Myocardial Fibrosis
Echocardiography Findings in Patients With Myocardial Fibrosis and Severe Aortic Stenosis
Patients with aortic stenosis waiting for aortic valve repair were investigated with echocardiography preoperatively, and a myocardial biospy was taken during the operation.
- Trial name
- SAS-fibrosis (NCT07331116)
- Testing
- Transthoracic echocardiography, Cardiac magnetic resonance imaging
- Where
- Norway
- Volunteers
- 22 people
- Sponsor
- Norwegian University of Science and Technology
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
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 Stenosis, Cardiogenic Shock
Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR
The goal of this clinical trial is to evaluate the feasibility, effectiveness, and safety of pre-emptive left atrial veno-arterial extracorporeal membrane oxygenation (LAVA-ECMO) in patients undergoing complex and high-risk…
- Conditions
- Severe Aortic Stenosis, Cardiogenic Shock, Cardiogenic Shock, ECMO, Trans-catheter Aortic Valve Implantation
- Trial name
- PROTECT-TAVR (NCT07309029)
- Testing
- Left Atrial Veno-Arterial Extracorporeal Membrane Oxygenation (LAVA-ECMO)
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Atlantic Health System