Clinical trials: Aortic Stenosis Symptomatic
Aortic Valve Stenosis
Pressure Gradient vs. Flow Relationships in Patients With Symptomatic Valvular Aortic Stenosis
The objective of the present study is to investigate to hemodynamic profile at rest and during peak exercise of patients with suspected severe aortic stenosis and to compare flow- and pressure changes between high gradient…
- Trial name
- PREFLOW (NCT05580237)
- Testing
- Simultaneous right and left heart catheterization
- Where
- Denmark
- Volunteers
- 26 people
- Sponsor
- Aarhus University Hospital Skejby
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
Aortic Stenosis
Frailty and Mortality in Older Old With Severe Aortic Stenosis
BACKGROUND.- The frailty syndrome (FS) associates an increase in morbidity and mortality in the elderly patient. When severe and symptomatic, aortic stenosis (AS) is a disease with poor prognosis, the most frequent cause of heart…
- Trial name
- SAS-frailty (NCT02745314)
- Testing
- Frailty measurement, Comprehensive Geriatric Assessment
- Where
- Spain
- Volunteers
- 605 people
- Sponsor
- Hospital de Meixoeiro
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
Obstructive Hypertrophic Cardiomyopathy
A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
The purpose of this observational post-marketing surveillance study is to assess the real-world safety of mavacamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adult participants in Korea.
- Trial name
- NCT06146660
- Testing
- Mavacamten
- Where
- 2 sites in South Korea
- Volunteers
- 600 people
- Sponsor
- Bristol-Myers Squibb
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
Obstructive Cardiomyopathy, Hypertrophic, Non-obstructive Hypertrophic Cardiomyopathy
A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy
The main purpose of the study is to determine the changes in symptoms and functional limitations in participants with symptomatic hypertrophic cardiomyopathy (HCM) treated with sotagliflozin as compared to placebo.
- Trial name
- SONATA-HCM (NCT06481891)
- Testing
- Sotagliflozin
- Where
- 108 sites in United States, Argentina and 17 more
- Volunteers
- 500 people
- Sponsor
- Lexicon Pharmaceuticals
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
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
Hypertrophic Cardiomyopathy (HCM)
Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3773274 in Adults With Hypertrophic Cardiomyopathy
This study is being performed to understand the effect of different doses of CK-3773274 on patients with hypertrophic cardiomyopathy (HCM).
- Trial name
- REDWOOD-HCM (NCT04219826)
- Testing
- CK-3773274 (5 - 15 mg), CK-3773274 (10 - 30 mg)
- Where
- 22 sites in United States, Italy and 2 more
- Volunteers
- 96 people
- Sponsor
- Cytokinetics
Symptomatic Aortic Stenosis
Assessment of the St. Jude Medical PorticoTM Re-sheathable Aortic Valve System - Alternative Access
The purpose of this clinical investigation is to evaluate the use of the Portico ALC Delivery System to place a transcatheter aortic valve through an alternative access site, specifically subclavian/axillary or TAo.
- Trial name
- PorticoALTEU (NCT02088021)
- Testing
- Portico Transcatheter Aortic Valve
- Sponsor
- Abbott Medical Devices
Non-obstructive Hypertrophic Cardiomyopathy, Hypertrophic Cardiomyopathy
Effect of Personalized Accelerated Pacing in Symptomatic Patients With Non-Obstructive Hypertrophic Cardiomyopathy
This will be a two-arm investigator-initiated randomized controlled study of patients with nHCM and LV ejection fraction ≥50% and NYHA II-III symptoms, normal intrinsic conduction system and pre-existing suitable dual-chamber…
- Trial name
- PACE-nHCM (NCT06775886)
- Testing
- myPACE+ algorithm
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Montefiore Medical Center
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
Aortic Valve Stenosis, Heart Valve Diseases
JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study
To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes…
- Conditions
- Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT02732691
- Testing
- JenaValve Pericardial TAVR System
- Where
- 13 sites in United States, Germany and 2 more
- Volunteers
- 68 people
- Sponsor
- JenaValve Technology, Inc.
Symptomatic Aortic Stenosis
ACURATE TA™ Valve Implantation: SAVI Registry (Surveillance Plan #2011-02) (TA-SAVI)
Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to provide safety surveillance of the device.
- Trial name
- NCT03143686
- Testing
- ACURATE TA™ Transapical Aortic Bioprosthesis
- Where
- 17 sites in Argentina, Germany and 2 more
- Volunteers
- 250 people
- Sponsor
- Symetis SA
Symptomatic Aortic Stenosis
The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation
The Keystone Heart TriGuard™ HDH is an aortic embolism deflection device intended to reduce the amount of embolic material that may enter the carotid, subclavian, and vertebral arteries during transcatheter heart valve…
- Trial name
- NCT02536196
- Testing
- Embolic Protection Device, Transcatheter aortic valve implantation (TAVI)
- Where
- 30 sites in United States, Germany and 2 more
- Volunteers
- 478 people
- Sponsor
- Keystone Heart
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
Obstructive Hypertrophic Cardiomyopathy, Mavacamten
Efficacy of Mavacamten Combined With Radiofrequency Ablation in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
This study aims to evaluate the efficacy and safety of Mavacamten combined with radiofrequency ablation compared to Mavacamten alone in patients with symptomatic obstructive hypertrophic cardiomyopathy (HOCM).
- Conditions
- Obstructive Hypertrophic Cardiomyopathy, Mavacamten, Radiofrequency Ablation
- Trial name
- NCT06856265
- Testing
- radiofrequency ablation, Mavacamten
- Volunteers
- 40 people
- Sponsor
- Shanghai Chest Hospital
Aortic Stenosis Symptomatic, Amyloidosis Cardiac
ATTR Amyloidosis in Elderly Patients With Aortic Stenosis
Severe aortic stenosis is defined with a mean transvalvular pressure gradient (MTPG) > 40mmHg and a calculated aortic valve area of < 1cm2.
- Trial name
- NCT04061213
- Testing
- Tc-99m-DPD scintigraphy
- Where
- Switzerland
- Volunteers
- 489 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Symptomatic Aortic Stenosis
ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis:CE-approval Cohort
First clinical experience on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human data pertaining to the safety and performance of the device from three different…
- Trial name
- NCT03003650
- Testing
- ACURATE TF™
- Where
- 6 sites in Brazil, Germany and 1 more
- Volunteers
- 89 people
- Sponsor
- Symetis SA