Clinical trials: Ventricular
Aortic Stenosis, Symptomatic Aortic Stenosis
Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study
To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.
- Conditions
- Aortic Stenosis, Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification
- Trial name
- DurAVR™ EFS (NCT05712161)
- Testing
- DurAVRTM THV System
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
Heart Failure, Cardiomyopathy, Dilated
Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction
This is a non-randomized, prospective, multi-center Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF).
- Trial name
- CorCinch-HFrEF (NCT03533517)
- Testing
- AccuCinch® Ventricular Restoration
- Where
- 18 sites in United States
- Volunteers
- 22 people
- Sponsor
- Ancora Heart, Inc.
Heart Failure
QUantum Genomics Incremental Dosing in Heart Failure - QUID-HF
Heart Failure (HF) a common clinical condition characterized by either by a heart that does not pump sufficiently or becomes stiff. A variety of mechanisms contribute to progressive cardiac remodeling and dysfunction.
- Trial name
- QUID-HF (NCT02780180)
- Testing
- QGC001
- Where
- 23 sites in Czechia, France and 6 more
- Volunteers
- 23 people
- Sponsor
- Quantum Genomics SA
Heart Failure
Safety and Performance Evaluation of CircuLite Synergy
The purpose of the study is to demonstrate the safety and functionality of the CircuLite Synergy Pocket Circulatory Assist Device.
- Trial name
- NCT00878527
- Testing
- CircuLite Synergy Pocket Circulatory Assist Device
- Where
- 11 sites in Belgium, Germany and 3 more
- Volunteers
- 63 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation, Tachycardia, Supraventricular
TOCCATA - Touch+™ for Catheter Ablation
The main objective of this study is to demonstrate the clinical safety of a contact force sensing RF ablation catheter when used for the treatment of supraventricular tachycardia and atrial fibrillation.
- Trial name
- TOCCATA (NCT01223469)
- Testing
- Contact force assisted irrigated RF ablation
- Volunteers
- 77 people
- Sponsor
- Abbott Medical Devices
Congenital Heart Disease
Study to Assess Safety of the Pulmonary Valved Conduit (PV-001) in Subjects Undergoing Right Ventricular Outflow Tract Reconstruction
The study is a prospective, non-randomised, open label clinical study to assess the safety of the Bioabsorbable Pulmonary Valved (PV) conduit (PV-001) in subjects > 2 years and < 22 years of age, undergoing Right Ventricular…
- Trial name
- NCT02700100
- Testing
- Bioabsorbable Pulmonary Valved Conduit (PV-001)
- Where
- 3 sites in Hungary, Malaysia and 1 more
- Volunteers
- 12 people
- Sponsor
- Xeltis
Aortic Stenosis Senile, Aortic Stenosis Symptomatic
Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis
The objective of this pivotal, prospective, multicenter, single-arm clinical trial is to evaluate the safety and clinical performance of the Next-Generation INOVARE® SAFESYNC Bioprosthetic Heart Valve, implanted via a…
- Conditions
- Aortic Stenosis Senile, Aortic Stenosis Symptomatic, Aortic Stenosis
- Trial name
- SAFESYNC NG (NCT07806409)
- Testing
- INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve
- Volunteers
- 40 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Severe Aortic Stenosis, Valve-in-valve Procedures
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic…
- Trial name
- PARADIGM (NCT07194265)
- Testing
- TAVR with DurAVR® THV, TAVR with SAPIEN THV series or the Evolut THV series
- Where
- Denmark
- Volunteers
- 1,650 people
- Sponsor
- Anteris Technologies Ltd.
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.
- Conditions
- Coronary Artery Disease, High Risk Percutaneous Coronary Intervention, Interventional Cardiology, Mechanical Circulatory Support
- Trial name
- SUPPORT II (NCT07296744)
- Testing
- The Supira System, Impella
- Where
- 26 sites in United States
- Volunteers
- 358 people
- Sponsor
- Supira Medical
Heart Failure
Feasibility Study of Radiofrequency Heating of Cardiac Infarction Scar to Treat Heart Failure
The purpose of this study is to examine the safety and potential effectiveness of a new surgical procedure for treating heart failure.
- Trial name
- RECOVER (NCT00881777)
- Testing
- Radiofrequency heating of the myocardial infarct scar, Coronary Artery Bypass Grafting (CABG) surgery
- Where
- 3 sites in Paraguay, Poland
- Volunteers
- 3 people
- Sponsor
- CoRepair, Inc.
Right Ventricular Congenital Cardiopathies
Non Interventional Study on Pulmonary Valve Replacement by Thranscatheter Pulmonary Valve Melody™
Prospective, longitudinal, open-label, multicentre, observational, non-comparative national study using an exhaustive registry of implantations over a given period.
- Trial name
- Melody™FR (NCT02023775)
- Testing
- Melody valve implantation
- Where
- 10 sites in France
- Volunteers
- 409 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Arrythmia, Ventricular Fibrillation
Assessment of a Chronically Implanted Parasternally Delivered EV-ICD Lead (ASCEND EV) Study
The ASCEND EV Study is a prospective, multi-center, single-arm, non-randomized study without concurrent or historical controls. The purpose of the study is to evaluate the Investigational Devices through at least 3-months of…
- Conditions
- Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia
- Trial name
- ASCEND EV (NCT06592001)
- Testing
- Atala™ lead
- Where
- 3 sites in Croatia, New Zealand and 1 more
- Volunteers
- 19 people
- Sponsor
- AtaCor Medical, Inc.
Left Ventricular Dysfunction, Acute Myocardial Infarction
UC-MSC Transplantation for Left Ventricular Dysfunction After AMI
A pilot study to evaluate the safety and feasibility of umbilical cord mesenchymal stem cells in the treatment of acute myocardial infarction by catheter transplantation
- Trial name
- NCT03902067
- Testing
- UC-MSC, Control Group
- Where
- China
- Sponsor
- Shanghai Life Science & Technology
High-Risk PCI
SAVE-PCI: NyokAssist™ Small-Bore VAD vs. IABP in Elective High-Risk PCI
SAVE-PCI is a prospective, multi-center, randomized controlled trial evaluating the safety and efficacy of NyokAssist™, a small-bore percutaneous ventricular assist device (pVAD), in comparison with intra-aortic balloon pump…
- Trial name
- NCT07010965
- Testing
- NyokAssist™, IABP Intra-aortic balloon pump
- Where
- 12 sites in China
- Volunteers
- 236 people
- Sponsor
- magAssist, Inc.
Aortic Stenosis
ACURATE Neo™ TA Delivery System in Patient With Severe Aortic Stenosis
The purpose of this investigation is to collect data pertaining to the safety and performance of the ACURATE neo (TM) Aortic Bioprosthesis as implanted with the ACURATE neo (TM) TA Transapical Delivery System.
- Trial name
- NCT02950428
- Testing
- ACURATE neo™TA Delivery System
- Where
- 7 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Symetis SA
Monomorphic Ventricular Tachycardia
Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia
To demonstrate that scar-based ventricular tachycardia (VT) ablation using the FlexAbility™ ablation catheter system results in a superior clinical outcome compared to routine drug therapy in subjects with documented Monomorphic…
- Trial name
- STAR-VT (NCT02130765)
- Testing
- Cardiac catheter ablation with ICD/CRT-D
- Where
- 38 sites in United States, Australia and 3 more
- Volunteers
- 64 people
- Sponsor
- Abbott Medical Devices
Aortic Stenosis
SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice
This is an international, mutli-center, prospective, consecutively enrolled, observational registry. 2000 patients are planned to be enrolled over one year at up to 150 participating sites.
- Trial name
- SOURCE 3 (NCT02698956)
- Testing
- TAVI (Transcatheter Aortic Valve Implantation)
- Where
- 73 sites in Denmark, Finland and 8 more
- Volunteers
- 2,000 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis, Aortic Insufficiency
Freedom SOLO Stentless Heart Valve Study
The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the Freedom SOLO heart valve.
- Trial name
- SOLO (NCT01115907)
- Testing
- Freedom SOLO Stentless Heart Valve
- Where
- 15 sites in United States, Canada
- Volunteers
- 251 people
- Sponsor
- Sorin Group USA, Inc.
Aortic Valve Insufficiency, Aortic Valve Regurgitation
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
- Conditions
- Aortic Valve Insufficiency, Aortic Valve Regurgitation, Aortic Valve Stenosis, Aortic Valve Incompetence
- Trial name
- NCT00636987
- Testing
- Biocor and Biocor Supra valves
- Where
- 17 sites in United States
- Volunteers
- 297 people
- Sponsor
- Abbott Medical Devices
Mitral Regurgitation
HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
- Trial name
- HighFLO (NCT04888247)
- Testing
- CLARITY
- Where
- 14 sites in Australia, Belgium and 4 more
- Volunteers
- 30 people
- Sponsor
- HighLife SAS
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