Clinical trials: Ventricular
Hypertrophic Cardiomyopathy, Nonsustained Ventricular Tachycardia
Extended ECG Monitoring in HCM Patients
The purpose of this study is to determine, among a large cohort of 300 consecutive patients with hypertrophic cardiomyopathy, if extended ambulatory monitoring using the iRhythm Technologies, Inc.
- Conditions
- Hypertrophic Cardiomyopathy, Nonsustained Ventricular Tachycardia, Ventricular Tachycardia, Atrial Fibrillation
- Trial name
- EXAMINE-HCM (NCT04056715)
- Testing
- Zio XT
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- iRhythm Technologies, Inc.
Severe Isolated Left Ventricular Dysfunction, Severe Biventricular Dysfunction
Berlin Heart EXCOR Pediatric Post Approval Study
The purpose of this post-approval study of the EXCOR® Pediatric VAD is to evaluate whether safety and outcomes of the device use in the commercial setting are comparable to the safety and outcomes of the device use in the IDE…
- Trial name
- NCT01674699
- Testing
- EXCOR Pediatric
- Volunteers
- 49 people
- Sponsor
- Berlin Heart, Inc
Ventricular Arrythmia, Ventricular Tachycardia
Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study
STEP ICD is a premarket, exploratory, early feasibility, interventional study designed to evaluate the preliminary safety and performance of the Investigational Devices.
- Conditions
- Ventricular Arrythmia, Ventricular Tachycardia, Ventricular Fibrillation
- Trial name
- NCT05791032
- Testing
- AtaCor EV-ICD Lead
- Where
- Paraguay
- Volunteers
- 21 people
- Sponsor
- AtaCor Medical, Inc.
Heart Failure
Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement
IMPROVE RESPONSE is a physician initiated research study. It is a prospective, non-randomized, multi-center, post-market, U.S. Cardiac Resynchronization Therapy (CRT) in heart failure (HF) observational study.
- Trial name
- NCT03305393
- Testing
- Adaptiv CRT
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Stern Cardiovascular Foundation, Inc.
Aortic Valve Disease, Aortic Valve Stenosis
Early Feasibility Study for the Foldax Tria Aortic Heart Valve
The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Aortic Valve to collect evidence on the device's safety and performance.
- Trial name
- NCT03851068
- Testing
- Foldax Tria Aortic Valve
- Where
- 5 sites in United States
- Volunteers
- 40 people
- Sponsor
- Foldax, Inc
Acute Myocardial Infarction
IRIS : Use of Implantable Defibrillator in High-risk Patients Early After Acute Myocardial Infarction
Of the patients who survive hospitalization after an acute myocardial infarction, ca. 10% die of sudden cardiac death in the following 2 years. The prognosis appears not improved by medication with antiarrhythmics (class I/III).
- Trial name
- NCT00157768
- Testing
- Implantable cardioverter defibrillator
- Where
- Netherlands
- Volunteers
- 900 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Symptomatic Severe Native Aortic Stenosis, Aortic Stenosis
STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)
To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.
- Trial name
- NCT07278310
- Testing
- TAVR Device, Siegel TAVR Device
- Where
- United States
- Volunteers
- 1,025 people
- Sponsor
- MiRus
Torsades de Pointes
A Study to Evaluate How VI-0521 Affect Cardiac Repolarization in Healthy Male and Female Volunteers
Determine whether VI-0521 has an effect on the electrical activity of the heart in healthy subjects. Find out how much VI-0521 is in the blood and any potential side effects on ECG's of healthy subjects after taking the study…
- Trial name
- TQT (NCT00839891)
- Testing
- VI-0521
- Where
- United States
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- VIVUS LLC
Congestive Heart Failure
EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant
Use of the EnSite NavX system to map the coronary vasculature during CRT implant
- Trial name
- Bi-VNavX (NCT01615835)
- Testing
- EnSite NavX System
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis
Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Early Feasibility Trial
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
- RADIANT (NCT02799823)
- Testing
- HLT Transcatheter Aortic Valve System
- Where
- 5 sites in United States
- Volunteers
- 11 people
- Sponsor
- HLT Inc.
Heart Failure, Cardiovascular Diseases
Novel INXN-4001 Triple Effector Plasmid in Heart Failure
To evaluate the safety of retrograde coronary sinus infusion (RCSI) of a novel triple-effector plasmid (INXN-4001) in outpatient LVAD recipients as assessed by incidence of all study intervention-related adverse events occurring…
- Conditions
- Heart Failure, Cardiovascular Diseases, Heart-Assist Device
- Trial name
- NCT03409627
- Testing
- INXN-4001
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Triple-Gene, LLC
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.
Aortic Valve Stenosis
Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the St. Jude Medical Transfemoral Delivery System
Collect and evaluate the long term safety data.
- Trial name
- NCT01497418
- Where
- 2 sites in Canada
- Volunteers
- 2 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Ventricular Dysfunction
Study of the Wearable Defibrillator in Heart-Failure Patients
The purpose of the study is to evaluate the safety and efficacy of wearable defibrillator use in patients with left ventricular dysfunction or advanced heart failure symptoms, who have a high-risk for sudden cardiac death but are…
- Conditions
- Heart Failure, Ventricular Dysfunction, Sudden Death, Sudden Cardiac Arrest
- Trial name
- SWIFT (NCT01326624)
- Testing
- wearable defibrillator (LifeVest)
- Where
- 2 sites in United States, Israel
- Volunteers
- 25 people
- Sponsor
- Zoll Medical Corporation
Cerebrospinal; Disorder
External Ventricular Drainage Post-Market Clinical Follow-up Registry
This post-market follow-up registry will capture clinical data specific to the safety and performance of the Integra External Ventricular Drainage Systems and Accessories.
- Trial name
- NCT05652296
- Testing
- External Ventricular Drainage (EVD)
- Where
- 4 sites in Belgium, France
- Volunteers
- 120 people
- Sponsor
- Integra LifeSciences Corporation
Ventricular Pacing With Rate Response, Bradycardia
Chronic Evaluation of Novel Pacemaker System
The primary study objective is to evaluate the feasibility, initial clinical safety and potential effectiveness of the Calyan Pacemaker system.
- Trial name
- NCT06056817
- Testing
- Calyan Pacemaker
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Calyan Technologies
Congestive Heart Failure
Device Evaluation of Contak Renewal 2and Easytrak 2 - DECREASE-HF
The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the CONTAK® RENEWAL™ 2/4/4HE cardiac resynchronization therapy defibrillator (CRT-D) family and EASYTRAK® 2 lead in delivering LV-CRT or…
- Trial name
- NCT00158951
- Testing
- CONTAK RENEWAL 2/4/4HE CRT-D, EASYTRAK 2 Lead
- Where
- United States
- Volunteers
- 360 people
- Sponsor
- Boston Scientific Corporation
Advanced Refractory Left Ventricular Heart Failure
MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS
The study will be a prospective, multi-center, non-blinded, controlled study, intended to evaluate the extended use of the HM3 LVAS compared to the HMII LVAS in those patients that are ongoing at the 2-year follow-up in the…
- Trial name
- NCT03982979
- Testing
- HM3 LVAS
- Where
- United States
- Volunteers
- 295 people
- Sponsor
- Abbott Medical Devices
Arrhythmia
Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search Study
The purpose of this study is to determine if patients implanted with a St. Jude Medical (SJM) implantable cardioverter defibrillator (ICD) will benefit by using AutoIntrinsic Conduction Search (AICS) rather than only a programmed…
- Trial name
- NCT00187239
- Testing
- Autointrinsic Conduction Search Algorithm
- Where
- United States
- Volunteers
- 157 people
- Sponsor
- Abbott Medical Devices
Intraventricular Hemorrhage, Subarachnoid Hemorrhage
Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System
The purpose of this non-significant risk study is to establish initial baseline infection rates for the Codman BACTISEAL External Ventricular Drainage (B-EVD) System (Antibiotic impregnated catheter) and to compare relative rates…
- Trial name
- NCT00197392
- Testing
- Bactiseal TM EVD, Standard EVD Catheter
- Where
- 20 sites in United States, Canada and 6 more
- Volunteers
- 434 people
- Sponsor
- Codman & Shurtleff
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