Clinical trials: Aortic Valve Replacement
Aortic Stenosis
PERIGON Pivotal Trial
To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.
- Trial name
- PERIGON (NCT02088554)
- Testing
- Model 400 aortic valve bioprosthesis
- Where
- 38 sites in United States, Canada and 6 more
- Volunteers
- 1,312 people
- Sponsor
- Medtronic Cardiac Surgery
Postoperative Kidney Injury
Use of 6% Hydroxyethylstarch (130/0.4) in Cardiac Surgical Patients
The purpose of this study is to evaluate the safety of a standard volume replacement called HES 130/0.4 (Voluven) during surgery on recovery.
- Trial name
- SHARP (NCT02192502)
- Testing
- human albumin 5%, HES 130/0.4 (Voluven)
- Where
- United States
- Volunteers
- 149 people
- Sponsor
- The Cleveland Clinic
Anesthesia, General
Efficacy and Safety of Ciprofol Compared to Propofol for Nonintubated General Anesthesia in Patients Undergoing TAVR
The purpose of this study is to explore the efficacy and safety of ciprofol compared to propofol for non-intubated general anesthesia in patients undergoing transcatheter aortic valve replacement (TAVR).
- Trial name
- NCT05035069
- Testing
- Ciprofol, Propofol
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Symptomatic Aortic Stenosis
First in Human Experience of the St. Jude Medical TAVI Valve and Delivery System
The purpose of this first-in-human study is to assess the technical feasibility, deployment characteristics, and safety of the 23mm SJM Transfemoral Transcatheter Heart Valve and delivery system in subjects with severe…
- Trial name
- SJM TAVI FIH (NCT01487330)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Abbott Medical Devices
Aortic Regurgitation
3-Dimensional Simulation Guided Transcatheter Aortic Valve Replacement in Aortic Regurgitation(DIGITAL)
This study will evaluate the safety and efficacy of postmarket bioprosthetic aortic valve in patients with severe aortic regurgitation undergoing transapical transcatheter aortic valve replacement based on 3D simulation…
- Trial name
- DIGITAL (NCT07398911)
- Testing
- 3D simulation technique
- Where
- China
- Volunteers
- 354 people
- Sponsor
- Xijing Hospital
Aortic Valve Disease, Aortic Valve Stenosis
Re-hospitalisation After Transcatheter Aortic Valve Implantation
The goal of this study is to investigate whether patient-tailored follow-up for patients treated with transcatheter aortic valve implantation (TAVI) can prevent re-hospitalisation and improve quality of life compared with the…
- Trial name
- HOSPITAVI (NCT05670041)
- Testing
- Intensified follow-up
- Where
- Denmark
- Volunteers
- 500 people
- Sponsor
- Ole De Backer
Severe Aortic Stenosis, Aortic Valve Stenosis
HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON
The purpose of this study is to evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at High Risk for aortic valve replacement surgery.
- Trial name
- HORIZON (NCT02157142)
- Testing
- HLT Transcatheter Aortic Valve System
- Where
- Germany
- Volunteers
- 4 people
- Sponsor
- HLT Inc.
Hemodynamic Monitoring, Cardiac Output
Stroke Volume Analysis During Aortic Valve Replacement Trial
Compromised peripheral tissue oxygenation during surgery may lead to worse patient outcome, mainly due to post-operative infections or heart failure.
- Conditions
- Hemodynamic Monitoring, Cardiac Output, Cardiac Surgery
- Trial name
- standart (NCT02156856)
- Where
- Germany
- Volunteers
- 68 people
- Sponsor
- Charite University, Berlin, Germany
Aortic Stenosis
Non-contrast 3-dimensional Cardiac Magnetic Resonance Imaging
Non-contrast enhanced cardiac MRI using 3D whole heart acquisition protocol is non-inferior to contrast enhanced CT in the assessment of aortic annulus complex for pre-TAVR imaging.
- Trial name
- NCT04496297
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- Baylor Research Institute
Aortic Stenosis
Aortic Stenosis and PhosphodiEsterase iNhibition With Aortic Valve Replacement (ASPEN-AVR): A Pilot Study
Currently, aortic stenosis (AS) is considered a "surgical disease" with no medical therapy available to improve any clinical outcomes, including symptoms, time to surgery, or long-term survival.
- Trial name
- ASPEN-AVR (NCT01272388)
- Testing
- Tadalafil
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Washington University School of Medicine
Cardiac Surgery, Coronary Artery Bypass Graft
Micro- and Macro-Circulation in Cardiac Surgery Patients
The hypothesis under the study is that there could be a link between a dysfunction in peripheral microcirculation, sublingual microcirculation or cardiovascular control and the development of post cardiac surgery major…
- Conditions
- Cardiac Surgery, Coronary Artery Bypass Graft, Surgical Aortic Valve Replacement
- Trial name
- MiMaC (NCT05706545)
- Testing
- Acquisition of cardiovascular signals and microcirculation sidestream darkfield images
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- IRCCS Policlinico S. Donato
Transcatheter Aortic Valve Implantation
Physical Therapy and Occupational Therapy After Transcatheter Aortic Valve Replacement
Implementation of Physical Therapy (PT) and Occupational Therapy (OT) pathway (initiation of services on Post procedure day #1 and continued daily with focus on education and activity progression) for all patients undergoing a…
- Trial name
- PTOTtAVR (NCT03117296)
- Testing
- Post procedure daily PT and OT, PT post procedure, OT post procedure
- Where
- United States
- Volunteers
- 189 people
- Sponsor
- Henry Ford Health System
Aortic Stenosis, Non-Sustained VT
Mechanisms of Excess Risk in Aortic Stenosis
Aortic stenosis (AS) is caused by narrowing of one of the main heart valves. Replacing the valve is the only treatment to prevent the heart from failing or death.
- Conditions
- Aortic Stenosis, Non-Sustained VT, Heart Failure
- Trial name
- MASTER (NCT04627987)
- Testing
- Cardiac MRI scan, Serum biomarkers (High sensitivity troponin, NT-proBNP, Implantable Loop Recorder
- Where
- United Kingdom
- Volunteers
- 192 people
- Sponsor
- University College, London
Aortic Stenosis
The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study
Aortic stenosis (AS) affects approximately 5% of individuals >65 years old, with ~3% of people >75 years having moderate to severe disease.
- Trial name
- EASY-AS (NCT04204915)
- Testing
- Aortic valve replacement
- Where
- 110 sites in Australia, Belgium and 5 more
- Volunteers
- 2,104 people
- Sponsor
- University of Leicester
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 Disease
SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
This PAS is an observational, non-randomized, multi-center, single arm, clinical study to evaluate long term safety and effectiveness of the SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve (15…
- Trial name
- NCT03924661
- Testing
- Aortic Valve Replacement
- Where
- 13 sites in United States, Germany
- Volunteers
- 20 people
- Sponsor
- Abbott Medical Devices
Pacemaker, TAVI
TAVI PACER: A Two-step Risk Score for Prediction of Permanent Pacemaker Implantation After TAVI.
The need for permanent pacemaker implantation (PPMI) remains one of the most frequent complications after transcatheter aortic valve implantation (TAVI).
- Conditions
- Pacemaker, TAVI, Risk Score
- Trial name
- TAVI PACER (NCT06542380)
- Testing
- TAVI, pacemaker
- Where
- Germany
- Volunteers
- 1,000 people
- Sponsor
- German Heart Institute