Clinical trials: Transcatheter Valve Replacement
Atrial Fibrillation
Pharmacological Intervention to Prevent NOAF After TAVR
The goal of this clinical trial is to learn if amiodarone or metoprolol works to prevent new-onset atrial fibrillation (AF) in patients who develop certain atrial arrhythmias after transcatheter aortic valve replacement (TAVR).
- Trial name
- NCT07519161
- Testing
- Metoprolol succinate, Amiodarone
- Volunteers
- 198 people
- Sponsor
- Shanghai East Hospital
Stroke
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).
- Trial name
- PROTECTED TAVR (NCT04149535)
- Testing
- Sentinel® Cerebral Protection System
- Where
- 57 sites in United States, Australia and 4 more
- Volunteers
- 3,000 people
- Sponsor
- Boston Scientific Corporation
Pulmonary Valve; Failure, Percutaneous Pulmonary Valve Implantation
Transcatheter Pulmonary Valve Implantation With SAPIEN 3 Valve
Background Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right ventricular outflow tract dysfunction in patients with congenital heart diseases.
- Conditions
- Pulmonary Valve; Failure, Percutaneous Pulmonary Valve Implantation, Infective Endocarditis, Congenital Heart Disease
- Trial name
- EUROPULMS3 (NCT05264181)
- Testing
- Percutaneous pulmonary valve implantation
- Where
- France
- Volunteers
- 600 people
- Sponsor
- Centre Chirurgical Marie Lannelongue
Severe Aortic Stenosis
Safety and Efficacy of SYM-SV/DS-002 in Patients With Severe Aortic Stenosis
Safety and Efficacy of SYM-SV/DS-002 in Patients with Severe Aortic Stenosis
- Trial name
- NCT03004599
- Testing
- SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System
- Where
- 5 sites in Japan
- Volunteers
- 11 people
- Sponsor
- Medico's Hirata Inc.
Aortic Stenosis, Aortic Valve Stenosis
Standardized Invasive Hemodynamics for Elevated Gradients Post TAVR (DISCORDANCE TAVR)
The DISCORDANCE TAVR study will determine the discordance between echocardiography-derived and invasive transaortic gradients, as determined by a consistent and reproducible technique (Standardized Invasive Hemodynamics)…
- Trial name
- NCT04827238
- Testing
- Standardized Invasive Hemodynamics
- Where
- 9 sites in United States, Canada
- Volunteers
- 49 people
- Sponsor
- University of British Columbia
Aortic Valve Stenosis
The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.
- Trial name
- NCT03471065
- Testing
- SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV
- Where
- 6 sites in Canada, United Kingdom
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement
The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe…
- Trial name
- REPRISE III (NCT02202434)
- Testing
- Lotus Valve System, CoreValve/Evolut R Transcatheter Aortic Valve Replacement System, LOTUS Edge Valve System
- Where
- 58 sites in United States, Australia and 4 more
- Volunteers
- 1,425 people
- Sponsor
- Boston Scientific Corporation
Bioprosthesis Failure
Renato® Transcatheter Valve-in-Valve System Multicenter Registry Trial (China)
The Renato® transcatheter valve-in-valve system, developed by Balance Medical, is undergoing a multicenter registry trial across China.
- Trial name
- VIV (NCT07174531)
- Testing
- Transcatheter valve in Valve implantation
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Beijing Balance Medical Technology Co., Ltd
Aortic Stenosis, Severe
Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement
This study sought to evaluate the impact of Virtual Reality (VR) tools in procedural planning of transcatheter aortic valve replacement (TAVR).
- Trial name
- NCT04944667
- Testing
- TAVR planning
- Where
- Spain
- Volunteers
- 11 people
- Sponsor
- Centro Medico Teknon
Aortic Valve Stenosis
HLT Meridian Valve CE Mark Trial
To evaluate the safety and performance of the HLT System in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement…
- Trial name
- RADIANT CE (NCT03805711)
- Testing
- HLT® Transcatheter System
- Where
- Canada
- Volunteers
- 1 people
- Sponsor
- HLT Inc.
Aortic Valve Stenosis
Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement
Multicenter, prospective, observational study in aortic stenosis (AS) patients undergoing transcatheter aortic valve implantation (TAVI) or high-risk patients undergoing aortic valve replacement (AVR).
- Trial name
- CCQ (NCT01852552)
- Testing
- transcatheter aortic valve implantation, Aortic Valve Replacement
- Where
- Italy
- Volunteers
- 518 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Aortic Stenosis
CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System
The purpose of this registry is to collect specific health and patient data to identify more precisely the patient population undergoing TA aortic valve replacement with the ACURATE neo™ Aortic biprosthesis and ACURATE neo™ TA…
- Trial name
- NCT03454360
- Testing
- ACURATE neo™ Aortic Bioprosthesis
- Where
- 10 sites in Germany
- Volunteers
- 107 people
- Sponsor
- Symetis SA
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 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
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
Aortic Stenosis
ACURATE TA™ Valve Implantation Registry: SAVI 2
Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to collect continued surveillance data pertaining to…
- Trial name
- TA-SAVI2 (NCT02663375)
- Testing
- ACURATE TA™ Transapical Aortic Bioprosthesis
- Where
- 27 sites in Austria, Germany and 2 more
- Volunteers
- 250 people
- Sponsor
- Symetis SA
Aortic Valve Stenosis
Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device
This registry is designed to monitor the real world clinical performance and safety of the V8 device used to perform balloon aortic valvuloplasty (BAV).
- Trial name
- TAB-R (NCT02099942)
- Testing
- V8 Balloon Aortic Valvuloplasty (BAV) Catheter
- Where
- 7 sites in United States
- Volunteers
- 103 people
- Sponsor
- InterValve, Inc.
Aortic Stenosis, Severe
China S3 PMS: SAPIEN 3 China Post Market Registry Study
The objective of this study is to evaluate the long term safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve system in real world setting.
- Trial name
- NCT05168826
- Testing
- SAPIEN 3 Transcatheter Heart Valve
- Where
- 14 sites in China
- Volunteers
- 250 people
- Sponsor
- Edwards Lifesciences
Tricuspid Valve Regurgitation, Heart Valve Diseases
Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)
This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- NCT06569602
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 23 sites in Germany, Greece and 4 more
- Volunteers
- 500 people
- Sponsor
- Edwards Lifesciences
Transcatheter Aortic Valve Replacement, Mechanical Circulatory Support
Application of Emergent Peripheral Mechanical Circulatory Support in Transcatheter Aortic Valve Replacement for 6 Patients
Objective: To explore the experience of transcranial aortic valve replacement (TAVR) under emergency mechanical assisted circulation (MCS).Methods: A total of 6 patients who completed TAVR with the assistance of emergency MCS in…
- Trial name
- NCT04464356
- Testing
- mechanical circulatory support
- Where
- China
- Volunteers
- 6 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine