Clinical trials: Heart Disease
Heart Failure
C-Pulse IDE Feasibility Study- A Heart Assist System
The C-Pulse Feasibility Study is evaluating the safety and performance of a new product for the treatment of heart failure. The product is designed to help reduce the symptoms of heart failure and help patients function better…
- Trial name
- NCT00815880
- Testing
- C-Pulse™ (Implantable Counterpulsation Therapy)
- Where
- 6 sites in United States
- Volunteers
- 21 people
- Sponsor
- Nuwellis, Inc.
Cardiac Arrhythmia
An Evaluation of the Safety and Performance of the CathVision ECGenius® System.
The primary objective is to evaluate the safety and technical performance of the CathVision ECGenius® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available…
- Trial name
- NCT05301803
- Testing
- Electrophysiology procedure
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- CathVision ApS
Aortic Valve Stenosis
5 Year Observation of Patients With PORTICO Valves
The purpose of this clinical investigation is to further assess the performance and safety profile of the commercially-available Portico™ TAVI System in patients with severe symptomatic aortic stenosis.
- Trial name
- PORTICO-1 (NCT01802788)
- Testing
- St Jude Medical Portico replacement aortic valve, Transcatheter Aortic Valve Implant
- Where
- 60 sites in Australia, Belgium and 11 more
- Volunteers
- 1,032 people
- Sponsor
- Abbott Medical Devices
Persistent Atrial Fibrillation
Evaluation of the Phased Radio Frequency Ablation System
VICTORY AF is an IDE, prospective global, multi-center, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to evaluate the risk of procedure and/or device related strokes in…
- Trial name
- VICTORY-AF (NCT01693120)
- Testing
- Medtronic Phased RF Ablation System
- Where
- 40 sites in United States, Canada and 3 more
- Volunteers
- 199 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Heart Failure, Heart Failure, Systolic
COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure
The purpose of this study was to determine the effect of sacubitril/valsartan (LCZ696) vs. Enalapril on improvement in erectile function and ability in male patients with chronic heart failure with reduced ejection fraction and…
- Conditions
- Heart Failure, Heart Failure, Systolic, Erectile Dysfunction
- Trial name
- CONFIDENCE-HF (NCT03917459)
- Testing
- LCZ696, Enalapril
- Where
- 13 sites in Germany
- Volunteers
- 27 people
- Sponsor
- Novartis Pharmaceuticals
Class IV Angina
The PEARL 8.0 Post-Approval Study
This is a prospective single arm study of the Cardiogenesis PEARL 8.0 Handpiece Delivery System. The purpose of this study is to demonstrate that the 30 day mortality rate among patients who are treated with this device is less…
- Trial name
- NCT01845103
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Heart Arrhythmia
Feasibility Study of the µCor Heart Failure and Arrhythmia Management System (PATCH)
Prospective, non-interventional, feasibility study. 8 months, from start of screening to finishing the study. Multi-center study, with a maximum of 8 centers in Europe.
- Trial name
- PATCH (NCT04512703)
- Testing
- µCor
- Where
- Germany
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Zoll Medical Corporation
Coronary Artery Disease, Acute Coronary Syndrome
PRESSUREwire Study
The purpose of this study is to understand routine use of FFR (Fractional Flow Reserve) and alternate indices in clinical practice.
- Trial name
- NCT02935088
- Testing
- Fractional Flow Reserve
- Where
- 71 sites in United States, Austria and 13 more
- Volunteers
- 2,217 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Disease, Aortic Stenosis
Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement
Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively.
- Trial name
- PERSIST-AVR (NCT02673697)
- Testing
- Perceval valve, other stented biological valve
- Where
- 47 sites in United States, Austria and 10 more
- Volunteers
- 914 people
- Sponsor
- Corcym S.r.l
Coronary Artery Disease
Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care
The objective of the HeartFlow ADVANCE Registry is to evaluate utility, clinical outcomes and resource utilization of FFRCT-guided evaluation in clinically stable, symptomatic patients with coronary artery disease (CAD) in order…
- Trial name
- ADVANCE (NCT02499679)
- Volunteers
- 4,737 people
- Sponsor
- HeartFlow, Inc.
Heart Valve Diseases
Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve
To further evaluate the long term clinical safety and effectiveness of the Trifecta valve
- Trial name
- NCT01514162
- Testing
- Trifecta valve
- Where
- 6 sites in United States
- Volunteers
- 245 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation
Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP)
The purpose of this study is to assess the safety and technical feasibility of treating subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation in a minimally invasive thoracoscopic ablation…
- Trial name
- Staged DEEP (NCT01661205)
- Testing
- Ablation procedure staged catheter ablation
- Where
- 6 sites in United States, Belgium and 1 more
- Volunteers
- 30 people
- Sponsor
- AtriCure, Inc.
Atrial Fibrillation
Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF
The study is a prospective, multi-center, non-randomized, unblinded worldwide pre-market clinical study. The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelect™ PFA System for…
- Trial name
- PULSED AF (NCT04198701)
- Testing
- Medtronic PulseSelect Pulsed Field Ablation (PFA) System
- Where
- 41 sites in United States, Australia and 7 more
- Volunteers
- 421 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Coronary Artery Disease
Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm PTCA Dilatation Catheter
To evaluate the acute safety and device procedural success of the Emerge 1.20 mm PTCA dilatation catheter when used as a pre-dilatation device in the stenotic portion of coronary arteries or bypass grafts.
- Trial name
- NCT01635881
- Testing
- Emerge™ 1.20 mm PTCA Dilatation Catheter
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
Heart Failure
MOnitoring REsynchronization deviCes and cARdiac patiEnts
The objective of this study is to compare two different strategies of disease management in heart failure patients treated with cardiac resynchronization therapy devices 1. Remote monitoring with CareLink Network System 2.
- Trial name
- MORE-CARE (NCT00885677)
- Testing
- Medtronic CareLink® Network
- Where
- 64 sites in Czechia, France and 8 more
- Volunteers
- 918 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation
Non-Interventional Study Describing Direct Costs Related to Anti-coagulation Treatment
To describe the direct costs related to warfarin/apixaban treatment
- Trial name
- NCT04435769
- Where
- Czechia
- Volunteers
- 109 people
- Sponsor
- Pfizer
Severe Symptomatic Calcified Native Aortic Valve Stenosis
Cerebral Protection in Transcatheter Aortic Valve Replacement
The Sentinel System will be a safe and effective method for capturing and removing embolic material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce the ischemic burden in the cerebral anterior…
- Trial name
- NCT02214277
- Testing
- Cerebral Protection System-The SENTINEL System with TAVR, TAVR
- Where
- 15 sites in United States, Germany
- Volunteers
- 363 people
- Sponsor
- Claret Medical
Bleeding Disorder, Stroke, Ischemic
XIENCE 28 Global Study
XIENCE 28 Global Study is a prospective, single arm, multi-center, open label, non-randomized trial to further evaluate the safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of…
- Conditions
- Bleeding Disorder, Stroke, Ischemic, Stroke Hemorrhagic, Hematological Disease
- Trial name
- NCT03355742
- Testing
- XIENCE, DAPT
- Where
- 52 sites in Austria, Belgium and 11 more
- Volunteers
- 963 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
A Clinical Trial to Assess the SYNERGY 48 mm Stent System for the Treatment of Atherosclerotic Lesion(s)
EVOLVE 48 is a prospective, open label, single arm, multi-center trial. The purpose of this study is to assess the FDA requirement for safety and effectiveness of the SYNERGY 48 mm Coronary Stent System for the treatment of…
- Trial name
- EVOLVE48 (NCT03350542)
- Testing
- SYNERGY 48 mm
- Where
- 15 sites in United States, Latvia and 2 more
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation
Arrhythmias, Cardiac
Reveal In-Office Implants
The purpose of this study is to gather evidence about the safety and feasibility of performing the implant procedure for the Reveal Insertable Cardiac Monitor (ICM) in an office or clinic setting rather than the traditional…
- Trial name
- NCT01168427
- Testing
- Reveal® DX or Reveal® XT Insertable Cardiac Monitor
- Where
- 9 sites in United States
- Volunteers
- 66 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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