Clinical trials: Symptomatic Aortic Valve Stenosis
Cardiomyopathy, Hypertrophic
Pacemaker Therapy for Drug-refractory Symptoms in Mid-cavity Hypertrophic Cardiomyopathy
The main aim of this study is to assess the acute effects of a pacemaker on reducing abnormally high intracavity pressures in the hearts of patients with mid-cavity obstructive hypertrophic cardiomyopathy (HCM).
- Trial name
- NCT03450252
- Testing
- Active pacing, Back-up pacing
- Where
- United Kingdom
- Volunteers
- 17 people
- Sponsor
- Barts & The London NHS Trust
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
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM
The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction
- Trial name
- MAPLE-HCM (NCT05767346)
- Testing
- Aficamten (CK-3773274) (5 mg, 10 mg, 15 mg and 20 mg), Metoprolol succinate (50 mg, 100 mg, 150 mg and 200 mg)
- Where
- 71 sites in United States, Brazil and 11 more
- Volunteers
- 175 people
- Sponsor
- Cytokinetics
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
Hypertrophic Cardiomyopathy
Multi-center, Open-label, Single-ascending Dose Study of Safety and Tolerability of TN-201 in Adults With Symptomatic MYBPC3 Mutation-associated HCM
This is a first-in-human, non-randomized, open-label study designed to evaluate the safety, tolerability, and pharmacodynamics (PD) of TN-201 in adult patients with symptomatic hypertrophic cardiomyopathy (HCM) caused by…
- Trial name
- MyPEAK-1 (NCT05836259)
- Testing
- TN-201
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- Tenaya Therapeutics
Aortic Valve Stenosis
Everyday Practice With Transcatheter Aortic Valve Implantation
The purpose of this registry is to document the everyday practice in our centers with minimal invasive treatment of patients with aortic valve disease who were considered suitable for transfemoral aortic valve implantation by…
- Trial name
- EVERY-TAVI (NCT02289339)
- Testing
- aortic valve prostheses
- Where
- 2 sites in Germany
- Volunteers
- 2,370 people
- Sponsor
- LMU Klinikum
Hypertrophic Cardiomyopathy
Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic Cardiomyopathy
The primary objective of this study was to evaluate the effect of eleclazine (GS-6615) on exercise capacity as measured by Peak oxygen uptake (VO2) achieved during cardiopulmonary exercise testing (CPET), in participants with…
- Trial name
- LIBERTY-HCM (NCT02291237)
- Testing
- Eleclazine
- Where
- 46 sites in United States, Australia and 6 more
- Volunteers
- 172 people
- Sponsor
- Gilead Sciences
Aortic Valve Stenosis
accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis
Aim of this study is to evaluate whether microsurgical repair or replacement of the aortic valve is a treatment option for a subgroup of patients suffering from aortic Stenosis.
- Trial name
- REBOOT-PARADOX (NCT03863132)
- Testing
- TAVR
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- IHF GmbH - Institut für Herzinfarktforschung
Obstructive Hypertrophic Cardiomyopathy (oHCM)
Efficacy and Safety of an LVEF-Guided Mavacamten Dose Up-Titration Strategy in Chinese Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy
This study aims to evaluate whether, under a treatment strategy primarily guided by left ventricular ejection fraction (LVEF), dose up-titration in adult patients with symptomatic obstructive hypertrophic cardiomyopathy who have…
- Trial name
- NCT07807384
- Testing
- Mavacamten
- Volunteers
- 115 people
- Sponsor
- Second Affiliated Hospital of Nanchang University
Severe Symptomatic Aortic Stenosis
Microvascular Function in Patients Undergoing Transcatheter Aortic Valve Implant (TAVI) for Severe Symptomatic Aortic Stenosis: Association With Myocardial Fibrosis
Microvascular function in patients undergoing Transcatheter Aortic Valve Implant (TAVI) for severe symptomatic aortic stenosis: association with myocardial fibrosis
- Trial name
- NCT05326126
- Testing
- coronary physiology
- Where
- Italy
- Volunteers
- 75 people
- Sponsor
- Matteo Montorfano
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.
Aortic Symptomatic Stenosis
ACURATE™ Transapical Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2010-01)
The purpose of this study is to evaluate safety of the study device and study device performance in patients presenting with severe aortic stenosis who are considered to be high risk for open surgical repair.
- Trial name
- TA-PILOT (NCT03143673)
- Testing
- ACURATE TA™
- Where
- 5 sites in Germany
- Volunteers
- 50 people
- Sponsor
- Symetis SA
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 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 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 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
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
DurAVR™ THV EU-EFS
A prospective, non-randomized, single-arm, multi-center study designed to evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis or failed surgical…
- Conditions
- Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve Failure
- Trial name
- NCT06510855
- Testing
- DurAVR™ THV System
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
Critical Aortic Stenosis
THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.
- Trial name
- PARTNER (NCT00530894)
- Testing
- Edwards SAPIEN Transcatheter Heart Valve, Surgical Valve Replacement, medical management and/or balloon aortic valvuloplasty
- Where
- 26 sites in United States, Canada and 1 more
- Volunteers
- 1,057 people
- Sponsor
- Edwards Lifesciences
Severe Symptomatic Aortic Stenosis
Assessment of Neurologic Injury Subsequent to Transcatheter Aortic Valve Replacement: A Feasibility Study
The investigators seek to determine the feasibility of assessing neurologic injuries subsequent to transcathether aortic valve replacement (TAVR).
- Trial name
- TAVR-Neuro (NCT01927601)
- Where
- United States
- Sponsor
- University of Michigan
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