Clinical trials: Cardiac Disease
Aortic Stenosis
Performance and Safety of the Lotus™ Valve With a FLEXible Delivery System
To confirm the acute performance and safety of the Lotus™ Valve Flex System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical…
- Trial name
- NCT03043404
- Testing
- Transcatheter aortic valve replacement
- Where
- 2 sites in Australia
- Volunteers
- 4 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Atrial Flutter
Investigation of the Adagio Cryoablation System in Patients With Atrial Fibrillation
The objective of the study is to demonstrate the safety and feasibility of the Adagio Cryoablation System is subjects with Paroxysmal (PAF), Persistent (PsAF) and Long-Standing Persistent Atrial Fibrillation.
- Trial name
- CryoCure2 (NCT02839304)
- Testing
- Cryoablation System
- Where
- 3 sites in Belgium, France and 1 more
- Volunteers
- 80 people
- Sponsor
- Adagio Medical
Coronary Artery Disease
A Phase I Study in Healthy Volunteers to Evaluate the Safety of CardioPET™ in Detection of Coronary Artery Disease
Safety and dosimetry of CardioPET™ will be evaluated in normal healthy volunteers and CAD subjects both male and female between the ages of 50-85.
- Trial name
- NCT00413647
- Testing
- CardioPET
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Fluoropharma, Inc.
Mitral Regurgitation
The EMBRACE Registry: European Post-Market Registry for Catheter Based Mitral Valve Replacement
Post-market registry for post-market surveillance, as part of the post-market plan, for the HighLife transcatheter, transseptal, mitral valve replacement system in a real world commercial setting.
- Trial name
- EMBRACE (NCT07409285)
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- HighLife SAS
Heart Failure
Effectiveness and Reliability of VectSelect™ Feature for Avoidance of Phrenic Nerve Stimulation in Cardiac Resynchronisation Therapy (CRT) Patients
It's the aim of this study to analyse efficacy and reliability of VectSelect Feature for avoidance of phrenic nerve stimulation in cardiac resynchronisation therapy (CRT) patients.
- Trial name
- Efface (NCT01244308)
- Where
- 10 sites in Germany
- Volunteers
- 132 people
- Sponsor
- Abbott Medical Devices
Hypertension (HTN), Heart Failure With Preserved Ejection Fraction (HFpEF
Clinical Feasibility of Cardiac Neuromodulation Therapy for Heart Failure With Preserved Ejection Fraction
This is an open-label pilot study to evaluate the feasibility of Cardiac Neuromodulation Therapy (CNT) in patients with high blood pressure and heart failure who require dual-chamber pacemaker implantation or replacement.
- Conditions
- Hypertension (HTN), Heart Failure With Preserved Ejection Fraction (HFpEF, Hypertension, Systolic
- Trial name
- NCT07598760
- Testing
- Moderato Plus device with Cardiac Neuromodulation Therapy
- Where
- 2 sites in Georgia
- Volunteers
- 20 people
- Sponsor
- BackBeat Medical Inc
Atrial Fibrillation, Stroke
Long-term, Open-label Follow-up Treatment of Patients With A-fib Who Have Been Previously Treated With BIBR 1048
To determine the long term safety and efficacy of BIBR 1048 in patients with chronic atrial fibrilla tion, with or without concomitant chronic treatment with acetylsalicylic acid (ASA).
- Trial name
- NCT00157248
- Testing
- dabigatran etexilate
- Where
- 50 sites in United States, Denmark and 2 more
- Volunteers
- 361 people
- Sponsor
- Boehringer Ingelheim
Heart Failure, Left Ventricular Systolic Dysfunction
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period.
- Trial name
- NCT05714085
- Testing
- Vericiguat tablet, Vericiguat suspension
- Where
- 111 sites in United States, Belgium and 28 more
- Volunteers
- 342 people
- Sponsor
- Merck Sharp & Dohme LLC
Coronary Artery Disease, Coronary Restenosis
Absorb BVS vs. Drug Coated Balloon for Treatment Of ISR
AbsorbISR is a randomized, controlled trial, single center, prospective, not blinded to evaluate two strategies of in stent restenosis treatment: Implantation of drug eluting bioresorbable stent scaffold Absorb® vs.
- Trial name
- AbsorbISR (NCT02474485)
- Testing
- BVS Absorb implantation., DEB Sequent Please inflation., Control coronary angiography.
- Where
- Switzerland
- Volunteers
- 53 people
- Sponsor
- SIS Medical AG
Tricuspid Regurgitation Functional
Acute Safety and Efficacy of the Pivot Bridge System for Functional Tricuspid Regurgitation
The purpose of this clinical trial is as follows. To assess the safety of the investigational medical device "Pivot Bridge" in participants aged 18 years or older with massive or greater functinal tricuspid regurgitation (TR) who…
- Trial name
- Pivot TR (NCT07385625)
- Testing
- Pivot Bridge
- Where
- 4 sites in South Korea
- Volunteers
- 20 people
- Sponsor
- Tau-MEDICAL Co., Ltd.
Systolic Heart Failure
Spinal Cord Stimulation For Heart Failure
The primary objectives of this feasibility study are to determine the safety of spinal cord stimulation (SCS) as a therapy in patients with systolic heart failure and to gather observational information for potential efficacy…
- Trial name
- SCS HEART (NCT01362725)
- Testing
- Spinal cord stimulation system
- Where
- 5 sites in Australia, Hong Kong and 1 more
- Volunteers
- 20 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Tachycardia, Supraventricular
Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT)
The purpose of this study is to find out if specialized programs in the AT500 and EnRhythm pacemakers will reduce the number of irregular heartbeat in the upper chamber of the heart and reduce symptoms (such as shortness of…
- Conditions
- Atrial Fibrillation, Tachycardia, Supraventricular, Arrhythmia, Bradycardia
- Trial name
- NCT00289289
- Testing
- Intervention Pacing Features
- Where
- 38 sites in United States, Canada
- Volunteers
- 400 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
ST Elevation Myocardial Infarction
MGuard™ Prime Stent System Clinical Trial in Patients With Acute ST Elevation Myocardial Infarction
To evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of blocked arteries in coronary arteries in patients undergoing a stenting procedure due to having a heart attack.
- Trial name
- MASTER-II (NCT01869738)
- Testing
- MGuard Prime, (BMS/DES)
- Where
- 56 sites in United States, Belgium and 10 more
- Volunteers
- 310 people
- Sponsor
- InspireMD
Mitral Regurgitation, Mitral Insufficiency
Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification
This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular…
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Annular Calcification, Mitral Annulus Calcification
- Trial name
- NCT03539458
- Testing
- Tendyne Mitral Valve System
- Where
- 4 sites in United States
- Volunteers
- 11 people
- Sponsor
- Abbott Medical Devices
Atrial Septal Defect, Atrial Fibrillation
Feasibility Study on the VERAFEYE System
The objective of the study is to evaluate the performance of the VERAFEYE System in subjects entitled to undergo a standard of care ablation or closure procedure.
- Conditions
- Atrial Septal Defect, Atrial Fibrillation, Atrial Arrhythmia, Left Atrial Appendage Closure
- Trial name
- LUMINIzE (NCT05931835)
- Testing
- VERAFEYE System
- Where
- Ireland
- Volunteers
- 18 people
- Sponsor
- LUMA Vision Ltd.
Heart Failure
Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device
This clinical investigation is a prospective, non-randomized, multi-center, pivotal trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic feature "Physiological Diagnostic" (PhD).
- Trial name
- CLEPSYDRA (NCT02167789)
- Testing
- Paradym CRT 8770
- Where
- 50 sites in United States, Canada and 7 more
- Volunteers
- 520 people
- Sponsor
- LivaNova
Functional Mitral Regurgitation
Safety and Effectiveness Study of SQ-Kyrin TMVr System for Functional Mitral Regurgitation
To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter produced by Shanghai Shenqi Medical Technology Co., Ltd.
- Trial name
- NCT05988450
- Testing
- SQ-Kyrin Transcatheter Mitral Valve Repair System
- Where
- China
- Volunteers
- 125 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
Cardiovascular Diseases
Pivotal Study for the Cardiac Performance System (CPS)
This multi-center, observational study evaluates the accuracy of the Cardiac Performance System (CPS), a non-invasive device, for measuring hemodynamic parameters in adult patients undergoing clinically indicated right heart…
- Trial name
- NCT06870591
- Testing
- Cardiac Performance System (CPS)
- Where
- 10 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Sensydia Corporation
Atrial Fibrillation
Oral Anticoagulant Discontinuation, Adherence Patterns, Hospitalizations and Costs in Non-Valvular Atrial Fibrillation (NVAF) Patients
To describe the rate of discontinuation among Non-Valvular Atrial Fibrillation (NVAF) patients who were on warfarin and have switched to the Novel oral anticoagulants(NOACs).
- Trial name
- NCT02792335
- Testing
- apixaban, dabigatran, rivaroxaban
- Volunteers
- 28,000 people
- Sponsor
- Bristol-Myers Squibb
Systolic Heart Failure
DECIDE-HF: Heart Rate Variability in Heart Failure Patients
The purpose of this study is to determine whether heart rate variability-like parameters are related to changes in the disease status of a subject that suffers from a disease that decreases the pumping function of the heart.
- Trial name
- DECIDE-HF (NCT00949676)
- Where
- 5 sites in Belgium, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- Medtronic BRC