Clinical trials: ICD Malfunction
Heart Disease, Cardiovascular Disease
Remote Interrogation in Rural Emergency Departments
A retrospective, multi-center, proof-of-concept study to evaluate the use of remote monitoring in rural emergency departments to decrease time to treatment decision for pacemaker and defibrillator patients using the St Jude…
- Conditions
- Heart Disease, Cardiovascular Disease, Heart Failure, Arrhythmias, Cardiac
- Trial name
- REM RED (NCT02421549)
- Testing
- Unpaired remote monitoring transmitter
- Where
- United States
- Sponsor
- Abbott Medical Devices
Heart Failure, Ventricular Arrythmias
Safety and Efficacy of Automatic Testing Feature in New ICDs and CRT-Ds
This study is a prospective, non-randomized, multi-center clinical trial that will assess the safety and effectiveness of investigational models of the Promote™ RF CRT-D and Current™ RF ICD devices.
- Trial name
- NCT00746356
- Testing
- Testing of the autocapture features of the device
- Where
- 5 sites in United States
- Volunteers
- 128 people
- Sponsor
- Abbott Medical Devices
Persistent Atrial Fibrillation, Heart Failure
Atrial Fibrillation Management in Congestive Heart Failure With Ablation
It is the purpose of the study to show the benefit of the endocardial catheter ablation by pulmonary vein isolation in patients with persistent or longstanding persistent atrial fibrillation, low LVEF and requiring ICD or CRT-D…
- Conditions
- Persistent Atrial Fibrillation, Heart Failure, ICD
- Trial name
- AMICA (NCT00652522)
- Testing
- ICD/CRT implant, AF ablation, Best Medical Treatment
- Where
- 16 sites in Germany, Hungary and 1 more
- Volunteers
- 202 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Safety and Efficacy Study of the QuickFlex Micro Model 1258T Left Heart Pacing Lead
This is a prospective, multi-center non-randomized clinical study to evaluate the safety and efficacy of the QuickFlex Micro Model 1258T left ventricular lead in a heart failure patient population.
- Trial name
- NCT00763698
- Testing
- QuickFlex Micro Model 1258T Left Heart Lead
- Where
- 13 sites in United States
- Volunteers
- 86 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Tachycardia
Management and Detection of Atrial Tachyarrhythmias in Patients Implanted With BIOTRONIK DX Systems
This is an observational registry study aiming to collect data on efficacy and safety of the single chamber Biotronik DX system with enhanced atrial diagnostics. The minimal follow-up period is 24 months.
- Conditions
- Atrial Fibrillation, Tachycardia, ICD Therapy, Thromboembolic Events
- Trial name
- MATRIX (NCT01774357)
- Where
- Germany
- Volunteers
- 2,054 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure
Integrated Diagnostic for Heart Failure
A prospective post-market study to evaluate the performance and clinic usability of heart failure risk status (HFRS) feature on CareLink.
- Trial name
- NCT01798797
- Where
- 3 sites in Canada
- Volunteers
- 100 people
- Sponsor
- Medtronic
Heart Failure
Clinical Evaluation Of The PARADYM RF Device
The PARADYM RF ICDs (DR, VR and CRT)have been implemented with 3 innovative features: The new RV autothreshold algorithm which will help the physician in his diagnosis avoiding potential lost of capture.
- Trial name
- NCT01193634
- Testing
- VR 9250 / DR 9550 / CRT 9750
- Where
- Germany
- Volunteers
- 75 people
- Sponsor
- LivaNova
Heart Failure
REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- NCT00271154
- Testing
- Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT
- Where
- 65 sites in United States, Austria and 13 more
- Volunteers
- 684 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Coronary Artery Disease
Same Day Discharge (SDD) After Implantable Cardioverter Defibrillator (ICD) Implant
The purpose of this study is to determine whether it is safe to send patients home from the hospital on the same day following an implantable cardioverter defibrillator (ICD) implant.
- Trial name
- SDD for ICD (NCT01993862)
- Testing
- Same Day Discharge
- Where
- 28 sites in United States
- Volunteers
- 266 people
- Sponsor
- Abbott Medical Devices
Sudden Cardiac Death, Heart Failure
Next Generation INCEPTA Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT-D) Field Following Study
This study has 2 purposes: The first purpose of the study is to test a new family of Boston Scientific Implantable Cardioverter Defibrillators ("ICDs") and cardiac resynchronization therapy ICDs ("CRT-Ds") and show how well these…
- Trial name
- NOTICE-HF (NCT01227785)
- Testing
- INCEPTA ICD or CRT-D
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- Guidant Corporation
Ventricular Tachycardia, Cardiovascular Diseases
Genetic Substudy of the Alternans Before Cardioverter Defibrillator (ABCD) Trial
The ABCD clinical study (ClinicalTrials.gov Identifier NCT00187291) was designed to determine if a T-Wave Alternans (TWA) test is equivalent to an Electrophysiology Study (EPS) in predicting life-threatening heart rhythms in…
- Conditions
- Ventricular Tachycardia, Cardiovascular Diseases, Arrythmia, CVD
- Trial name
- ABCD (NCT00583297)
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- CardioDx
Heart Failure, Heart Failure NYHA Class II
Heart Failure Management for Patient With CIED Remotely Monitored
This randomized, controlled, open-label, parallel, multicenter clinical study evaluates the efficacy of SmartSignalHF compared with heart failure (HF) remote monitoring (RM) standard of care in implanted patients with heart…
- Conditions
- Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure With Reduced Ejection Fraction (HFrEF)
- Trial name
- PROACT-HF (NCT07247032)
- Testing
- SmartSignalHF, HF RM standard of care
- Where
- France
- Volunteers
- 1,132 people
- Sponsor
- Implicity
Heart Failure
A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure
The purpose of this clinical study is to estimate the safety and radiation dosimetry of a single dose of LMI1195 in healthy subjects and heart failure patients undergoing positron emission tomography (PET)
- Trial name
- NCT00891241
- Testing
- LMI 1195-101
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Lantheus Medical Imaging
Heart Failure
TRI-V Heart Failure (HF) Implanted Cardioverter Defibrillator (ICD) Study
It's the aim of this study to investigate the impact of Right Ventricular (RV) lead position (RV-apex, His bundle area, RV-apex+His bundle area) in combination with individually optimized Left Ventricular (LV) lead placement and…
- Trial name
- TRI-V (NCT00746135)
- Testing
- Device Implantation
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (HF) (REDUCEhf)
The purpose of this clinical research study is to evaluate the safety and effectiveness of the investigational implantable hemodynamic monitor (IHM), and of the IHM in combination with an implantable cardioverter defibrillator…
- Trial name
- REDUCEhf (NCT00354159)
- Testing
- Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD)
- Where
- 52 sites in United States
- Volunteers
- 442 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
CareLink® Network Evaluation
The purpose of the study is to demonstrate the value of the Medtronic CareLink® Network in clinical practice in the country specific healthcare setting.
- Trial name
- NCT01023022
- Testing
- Medtronic CareLink® Network
- Where
- 10 sites in Poland
- Volunteers
- 176 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
PRoMOTE Follow-up Observational Study
The purpose of the study is: To evaluate the Heart Failure Risk Status (HFRS) feature performance. To establish the feasibility of remote follow-up in which patient risk triaging is performed by nurse-led review of HFRS feature…
- Trial name
- PRoMOTE FU (NCT03009175)
- Testing
- Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy Defibrillator/Pacemaker
- Volunteers
- 287 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Tachycardia, Ventricular Fibrillation
DF4 Connector System Post-Approval Study
The purpose of this study is to evaluate long-term performance of the DF4 Connector System. This evaluation is based on the number of DF4 lead-related complications occurring during the study compared to the number of leads…
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Sudden Cardiac Death, Heart Failure
- Trial name
- NCT01638897
- Where
- 78 sites in United States, Canada and 1 more
- Volunteers
- 1,778 people
- Sponsor
- Medtronic
Advanced Heart Failure, CRT and/or ICD
Screening for Advanced Heart Failure Treatment (SEE-HF)
Advanced heart failure therapy (heart transplantation or LVAD) is underutilized and patients are underserved. The purpose of this prospective, observational study is to obtain multi-center data on the proportion of patients with…
- Trial name
- SEE-HF (NCT01626404)
- Where
- 7 sites in Denmark, France and 4 more
- Volunteers
- 99 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Arrhythmias, Cardiac
Heart Failure and Sudden Cardiac Death Japan Registry
The purpose of this observational registry is to collect clinical events and outcome data in 4 different study populations (cohorts), with a majority of Japanese subjects, that are at risk of sudden cardiac death (SCD) and heart…
- Conditions
- Heart Failure, Arrhythmias, Cardiac, Sudden Cardiac Death
- Trial name
- HINODE (NCT03185832)
- Testing
- CRT-D, ICD, PM / CRT-P
- Where
- 34 sites in Japan
- Volunteers
- 354 people
- Sponsor
- Boston Scientific Corporation