Clinical trials: ICD Malfunction
Sinus Node Disease
Clinical Benefits of the Closed Loop Stimulation in Sinus Node Disease
The study is designed as a multi-center, international, prospective, parallel, randomized, single blinded trial comparing the time to first primary endpoint event (Sustained Paroxysmal AF/Persistent AF or stroke/TIA) occurrence…
- Trial name
- B3 (NCT02579889)
- Testing
- DDD+CLS, DDD(R)
- Where
- 54 sites in China, Hungary and 7 more
- Volunteers
- 1,390 people
- Sponsor
- Biotronik SE & Co. KG
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
Tachyarrhythmias, Heart Failure
Safety and Clinical Performance of the Protecta ICD and CRT-D
The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects implanted with a Medtronic…
- Conditions
- Tachyarrhythmias, Heart Failure, Ventricular Dysfunction
- Trial name
- NCT00982397
- Testing
- Protecta VR-ICD, Protecta DR-ICD or CRT-D
- Where
- 122 sites in United States, Austria and 19 more
- Volunteers
- 2,770 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Cardiomyopathy
InSync Implantable Cardioverter Defibrillator Registry: Cardiac Resynchronization Therapy
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
- NCT00289302
- Testing
- Cardiac resynchronization therapy device
- Where
- 51 sites in United States
- Volunteers
- 600 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)
Heart Failure
Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry
MADIT-CRT PAR is an FDA mandated follow-up registry for patients that participated in the MADIT-CRT IDE study examining long-term mortality. (MADIT-CRT IDE: NCT00180271)
- Trial name
- MADIT-CRT PAR (NCT01294449)
- Testing
- MADIT-CRT ICD, MADIT-CRT CRT-D
- Where
- United States
- Volunteers
- 394 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.
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
Tachycardia, Heart Failure
BIO|CONCEPT.CorSky, First in Human Study for the CorSky ICD Family
The goal of this exploratory study is to test the preliminary safety and product performance of the new CorSky ICD family in subjects that require an ICD or cardiac resynchronization therapy with defibrillation (CRT-D).
- Trial name
- NCT06840509
- Testing
- CorSky ICD or CRT-D
- Where
- Australia
- Volunteers
- 52 people
- Sponsor
- Biotronik Australia Pty Ltd.
Primary Prevention, Tachycardia, Ventricular
Survival of Patients With Primary Prophylactic ICD Indication
The MADIT-II trial has shown that patients with severely reduced left ventricular ejection fraction (LVEF) post myocardial infarction benefit from the implantable cardioverter-defibrillator (ICD).
- Conditions
- Primary Prevention, Tachycardia, Ventricular, Sudden Cardiac Death
- Trial name
- SPIRIT-ICD (NCT00619593)
- Testing
- Intensified diagnostic and treatment measures following 1st appropriate ICD therapy, Standard follow-up
- Where
- 37 sites in Austria, Czechia and 9 more
- Volunteers
- 504 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure
Clinical Status Monitoring in Implantable Cardiac Defibrillator (ICD) Patients by Physiological Diagnosis (PhD) Function
The purpose of this study is to evaluate the performance of advanced features, that have been implemented in the PARADYM ICD Platform offering single chamber (VR - model 8250), dual Chamber (DR - 8550) and Cardiac…
- Trial name
- TUTOR (NCT01170624)
- Testing
- ICD
- Where
- 25 sites in Belgium, France and 3 more
- Volunteers
- 388 people
- Sponsor
- LivaNova
Heart Failure
Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement
Heart Failure (HF) is one of the most frequent diagnoses upon hospitalization and is a major cause of death. Cardiac resynchronization therapy (CRT) using an implantable device for synchronous bi-ventricular stimulation leads to…
- Trial name
- BIODetectHFII (NCT01711281)
- Testing
- Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)
- Where
- 22 sites in Denmark, Germany and 3 more
- Volunteers
- 68 people
- Sponsor
- Biotronik SE & Co. KG
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
Heart Failure, Heart Failure With Reduced Ejection Fraction
Assessment of Combined CCM and ICD Device in HFrEF
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or…
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Implantable Defibrillator User, CCM Therapy
- Trial name
- INTEGRA-D (NCT05855135)
- Testing
- OPTIMIZER® Integra CCM-D System (Treatment Arm)
- Where
- 59 sites in United States
- Volunteers
- 300 people
- Sponsor
- Impulse Dynamics
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
Heart Failure
Observational Study of ICD and Pacemaker Sensing in the Presence of IMED-4 Operation
The purpose is to monitor far field sensing artifacts of CRM devices in the presence of the IMED-4
- Trial name
- NCT02191696
- Testing
- IMED-4 recording
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Intersection Medical, Inc.
Heart Failure, Ventricular Arrythmia
ASCEND CSP IDE Study
This is a prospective, multi-center, global, single-arm, pivotal investigational study designed to evaluate the safety and effectiveness of the CSP ICD Lead in a subject population indicated for ICD or CRT-D therapy.
- Trial name
- ASCEND CSP IDE (NCT06830746)
- Testing
- LBBAP Implant with a CSP ICD Lead
- Where
- 37 sites in United States, Australia and 8 more
- Volunteers
- 414 people
- Sponsor
- Abbott Medical Devices
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
Heart Failure
Effective Study of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D (RHYTHM)
The purpose of this study was to generate effectiveness data of Angiotensin receptor neprilysin inhibitor (ARNI), in the Chinese Heart failure with reduced ejection fraction (HFrEF) patients with implantable cardioverted…
- Trial name
- RHYTHM (NCT04491136)
- Testing
- ACEI/ARB, ARNI
- Where
- 23 sites in China
- Volunteers
- 201 people
- Sponsor
- Novartis Pharmaceuticals
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