Clinical trials: ICD Malfunction
Heart Failure
International Study to Determine if AdreView Heart Function Scan Can be Used to Identify Patients With Mild or Moderate Heart Failure (HF) That Benefit From Implanted Medical Device
This is an event-driven Phase IIIb, multicentre, randomised, clinical study to demonstrate the efficacy of AdreView™ imaging for appropriately guiding the decision of implantable cardioverter defibrillator (ICD) implantation, in…
- Trial name
- ADMIRE-ICD (NCT02656329)
- Testing
- Iobenguane I -123 Injection, Implantable Cardioverter Defibrillator, Thyroid blocking
- Where
- 94 sites in United States, Canada and 8 more
- Volunteers
- 395 people
- Sponsor
- GE Healthcare
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, 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
Ventricular Fibrillation, Ventricular Tachycardia
SD01 Registry (SD01 ICD Lead)
This registry is designed to gather further evidence, in addition to the SD01 Master Study, for the safety and efficacy of the SD01 ICD lead.
- Conditions
- Ventricular Fibrillation, Ventricular Tachycardia, Heart Failure
- Trial name
- SD01 Registry (NCT02014675)
- Testing
- SD01 ICD lead
- Where
- 10 sites in Germany
- Volunteers
- 280 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 Disease, Cardiovascular Disease
Remote Device Interrogation In The Emergency Department
A prospective, post market, non-randomized study to evaluate the reduction in time to interrogation for patients with St. Jude Medical remote care compatible devices interrogated by the unpaired Merlin@home transmitter in the…
- Conditions
- Heart Disease, Cardiovascular Disease, Heart Failure, Arrhythmias, Cardiac
- Trial name
- REMEDY (NCT01871090)
- Testing
- Unpaired remote monitoring transmitter
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Ventricular Tachycardia
Compare Remote Patient Management and Standard Care in CRT-D and ICD-patients to Assess the Effect on Heart Failure
This pilot study is to prospectively evaluate the benefit of clinicians being able to access ICD device information in a timelier manner and treat fluid overload with a pre-defined pattern using the Medtronic OptiVol, Medtronic…
- Conditions
- Heart Failure, Ventricular Tachycardia, Cardiac Desynchronization
- Trial name
- ConnectOptiVol (NCT00730548)
- Testing
- Device triggered remote telephone contact because of Care Alert
- Where
- Germany
- Volunteers
- 180 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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, Ischemic Cardiomyopathy
18F-mFBG Imaging for Myocardial Sympathetic Innervation
This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of myocardial sympathetic innervation.
- Conditions
- Heart Failure, Ischemic Cardiomyopathy, ICD Patients
- Trial name
- NCT06965621
- Testing
- 18F-metaFluorobenzylguanidine, Rubidium-82
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
Long QT Syndrome, Wide QRS Complexes
ECG Signal Collection From Long QT Syndrome, Wide QRS Complexes, Heart Failure, and Cardiac Resynchronization Patients
The purpose of this study is to collect surface electrograms from standard and several non-standard configurations in patients with long QT syndrome, heart failure, cardiac resynchronization therapy or wide QRS during a routine…
- Conditions
- Long QT Syndrome, Wide QRS Complexes, Heart Failure, Cardiac Resynchronisation
- Trial name
- NCT00399412
- Testing
- subcutaneous ICD
- Where
- United Kingdom
- Volunteers
- 86 people
- Sponsor
- Boston Scientific Corporation
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
Congestive Heart Failure, Cardiac Resynchronization Therapy
TRIAGE-CRT Telemonitoring in Patients With CHF and Indication of CRT-D
This feasibility study will investigate the clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) and weight and blood pressure (BP) external telemonitoring (ETM) in the follow-up treatment of patients implanted…
- Trial name
- NCT00395642
- Testing
- Kronos LV-T, Lumax HF-T
- Where
- 12 sites in United States
- Volunteers
- 66 people
- Sponsor
- Biotronik, Inc.
Heart Failure, Ventricular Dysfunction
B-Left HF: Biventricular Versus Left Univentricular Pacing With Implantable Cardiac Defibrillator (ICD) Back-Up in Heart Failure Patients
The purpose of this study is to demonstrate that biventricular pacing (BiV) and left univentricular (left ventricular [LV] only) pacing are safe and effective for cardiac resynchronization therapy in heart failure patients…
- Conditions
- Heart Failure, Ventricular Dysfunction, Heart Diseases
- Trial name
- NCT00187213
- Testing
- Cardiac Resynchronization Therapy
- Where
- France
- Sponsor
- Abbott Medical Devices
Heart Failure, Congestive
X-Change HF - Exchange of the Existing Pacemaker/ICD in Bradycardia Patients Suffering From Heart Failure
The goal of X-Change HF is to estimate the effect of biventricular stimulation in patients who need antibradycardia ventricular stimulation (more than 80%); are eligible for the exchange of an old pacemaker or implantable…
- Trial name
- NCT00157846
- Testing
- CRT-P or CRT-D Device
- Where
- 10 sites in Germany
- Volunteers
- 36 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Heart Disease
Managed Ventricular Pacing ("MVP") Trial
The purpose of the study is to compare two device settings (sets of instructions) used by the ICD. The Implantable Cardiac Defibrillator ("ICD") can be set to use one wire (top or bottom of the heart) or two wires (top and…
- Trial name
- MVP (NCT00281099)
- Testing
- ICD (Implantable Cardioverter Defibrillator)
- Where
- 73 sites in United States, Austria and 10 more
- Volunteers
- 1,031 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Chronic Heart Failure
A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT)
Researchers are looking for a better way to treat people who have chronic heart failure. Chronic heart failure is a medical condition with shortness of breath, tiredness and ankle swelling in which the heart does not pump blood…
- Trial name
- REMOTE-HF (NCT05532046)
- Testing
- BAY2413555 Dose 1, BAY2413555 Dose 2
- Where
- 18 sites in United States, Denmark and 4 more
- Volunteers
- 22 people
- Sponsor
- Bayer
Ventricular Arrythmia, Lead
Safety and Electrical Performance Evaluation of INVICTA Leads Models Equipped With DF4 Connector
The primary objective of this study is to assess the safety and key electrical performance of the INVICTA leads equipped with DF4 connector: ACTIVE fixation type models (single and dual coil: INVICTA 1CR, INVICTA 2CR) and PASSIVE…
- Conditions
- Ventricular Arrythmia, Lead, ICD, Heart Failure
- Trial name
- FRIENDS (NCT03766919)
- Testing
- Implant of the INVICTA lead
- Where
- 10 sites in France, Italy and 2 more
- Volunteers
- 33 people
- Sponsor
- MicroPort CRM
Heart Failure, Congestive
PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure
The purpose of this study is to determine the value of diagnostic data obtained from Medtronic implantable cardioverter defibrillators (ICDs) with cardiac resynchronization therapy (CRT) to evaluate cardiovascular and heart…
- Trial name
- NCT00279955
- Testing
- Cardiac Resynchronization Therapy Device
- Where
- 93 sites in United States
- Volunteers
- 1,024 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure