Clinical trials: Implantable Cardioverter Defibrillators
Implantable Cardioverter Defibrillators, CRT-D Cardiac Resynchronization Therapy Defibrillator
LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices
The study is to determine the rate and cause of device replacements at 5 years post-implantation. It will assess the battery and device longevity of the Implantable Cardioverter Defibrillators (ICD) and CRT-D Cardiac…
- Trial name
- NCT02091011
- Where
- 80 sites in United States, Canada and 6 more
- Volunteers
- 1,600 people
- Sponsor
- Boston Scientific Corporation
Ventricular Tachycardia, Ventricular Fibrillation
DATAS: The Dual Chamber & Atrial Tachyarrhythmias Adverse Events Study
The Dual Chamber \& Atrial Tachyarrhythmias Adverse Events Study (DATAS) was designed to analyze the ability of dual chamber ICDs, to reduce clinically significant adverse events as compared to single chamber ICD in a non…
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Defibrillators, Implantable
- Trial name
- DATAS (NCT00157820)
- Testing
- Single Chamber Implantable Cardioverter Defibrillator, Dual Chamber implantable cardioverter defibrilator
- Volunteers
- 354 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)
Ventricular Tachycardia
Low Energy Therapy to Convert Ventricular Tachycardias
The LEVER study is a prospective, unblinded, non-randomized, first in human feasibility study that will assess and characterize early safety and effectiveness of low energy therapies in converting monomorphic ventricular…
- Trial name
- LEVER (NCT02891863)
- Testing
- LEVER Acute Study System
- Where
- Australia
- Volunteers
- 9 people
- Sponsor
- Boston Scientific Corporation
Cardiac Rhythm Disorder
3T MRI CIED Post-Approval Study
The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure.
- Trial name
- NCT02969395
- Where
- 204 sites in United States, Belgium and 20 more
- Volunteers
- 41 people
- Sponsor
- Medtronic
Ventricular Fibrillation, Ventricular Tachycardia
Further Acute Research of a Subcutaneous Implantable Defibrillator (S-ICD) System
The purpose is to further evaluate the operation, safety, and feasibility of a subcutaneous implantable defibrillator (S-ICD) system in patients who require an implantable cardioverter defibrillator (ICD)for treating ventricular…
- Trial name
- NCT00399217
- Testing
- Subcutaneous Implantable Defibrillator (S-ICD) system, ICD
- Where
- United Kingdom
- Volunteers
- 55 people
- Sponsor
- Boston Scientific Corporation
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
Ventricular Fibrillation, Ventricular Tachycardia
Remote Follow-up of Patients Receiving Implantable Cardioverter Defibrillator for Prophylactic Therapy
The completed MADIT II study has shown that implantation of a cardioverter-defibrillator (ICD) in patients with a reduced left ventricular ejection fraction and a prior myocardial infarction reduces death from any cause.
- Trial name
- REFORM (NCT00401466)
- Testing
- Implantable Cardioverter Defibrillator
- Where
- 5 sites in Czechia, Germany
- Volunteers
- 155 people
- Sponsor
- Biotronik SE & Co. KG
Arrhythmia
Efficacy and Safety Evaluation of Azimilide Dihydrochloride in Patients With Implantable Cardioverter Defibrillators
Implantable cardioverter defibrillators (ICDs) have been developed to treat ventricular tachycardia or fibrillation (abnormal heart rhythms) by electrical shock or by pacing the heart.
- Trial name
- NCT00035490
- Testing
- Azimilide Dihydrochloride
- Where
- 142 sites in United States, Belgium and 7 more
- Volunteers
- 633 people
- Sponsor
- Forest Laboratories
ICD, Cardiomyopathy Ischemic
Assessment of Risk Factors for Appropriate ICD (Implantable Cardioverter-defibrillator) Intervention in Patients With Ischemic Cardiomyopathy
Design: PARCADIA is a prospective non-randomized non-interventional multi-center clinical investigation in Europe. Patients with depressed LV (left ventricular) function assessed on local standards, of ischemic origin and on…
- Conditions
- ICD, Cardiomyopathy Ischemic, Primary Prevention
- Trial name
- PARCADIA (NCT04014946)
- Testing
- ICD implantation
- Volunteers
- 200 people
- Sponsor
- Biotronik SE & Co. KG
Tachycardia, Diabetes Mellitus
Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable Cardioverter Defibrillator
The MADIT S-ICD trial was designed to evaluate if subjects with a prior myocardial infarction, diabetes mellitus and a relatively preserved ejection fraction of 36-50% will have a survival benefit from receiving a subcutaneous…
- Conditions
- Tachycardia, Diabetes Mellitus, Cardiovascular Disease
- Trial name
- MADIT S-ICD (NCT02787785)
- Testing
- Subcutaneous Implantable Cardioverter Defibrillator
- Where
- 49 sites in United States, Germany and 5 more
- Volunteers
- 40 people
- Sponsor
- Boston Scientific Corporation
Ventricular Tachycardia, Monomorphic
Fast VT Episodes Are Terminated by ATP One Shot
Many arrhythmias detected in the ventricular fibrillation (VF)-zone picture monomorphic ventricular tachycardia (VT) and, hence, could be terminated by antitachycardia pacing (ATP) treatment.
- Trial name
- FavoriteATP (NCT00617578)
- Testing
- ATP One Shot ON, ATP One Shot OFF
- Where
- 14 sites in Austria, Finland and 2 more
- Volunteers
- 194 people
- Sponsor
- Biotronik SE & Co. KG
Ventricular Fibrillation
INSURE: INcidence Free SUrvival Before and After Implantable Cardioverter Defibrillator (ICD) Replacement
The INSURE trial is a multi-center, prospective trial to collect information about adequate ICD therapies in ICD patients before and after their first elective ICD replacement.
- Trial name
- NCT00180440
- Testing
- ICD
- Where
- Germany
- Volunteers
- 528 people
- Sponsor
- Guidant Corporation
Ventricular Arrythmias
Efficacy of the ATP Switch Automatic Programming in Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) Implanted Patients
Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple, dual or triple chamber ICD.
- Trial name
- ASAP (NCT01169246)
- Where
- France
- Volunteers
- 1,254 people
- Sponsor
- MicroPort CRM
Cardiac Disease
Lumax DX / Linox DX Evaluation
The objective of this study is to investigate the safety and efficacy of the Lumax DX / Linox DX system. No hypothesis has been defined.
- Trial name
- NCT01486836
- Where
- Germany
- Volunteers
- 38 people
- Sponsor
- Biotronik SE & Co. KG
Sudden Cardiac Death
Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study
The purpose of this post-approval study is to confirm the safety and effectiveness of Ovatio DR and VR ICDs
- Trial name
- Post-Ovatio (NCT00586378)
- Testing
- Ovatio DR and Ovatio VR
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- ELA Medical, Inc.
Heart Failure, Arrhythmias, Cardiac
Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement (HomeCARE II)
The new BIOTRONIK implantable cardioverter defibrillator (ICD) family Lumax 540 is capable of measuring the intrathoracic impedance on a daily basis and transmission of impedance trend data via the Home Monitoring technology.
- Trial name
- HomeCARE II (NCT00711360)
- Testing
- Intrathoracic impedance measurement
- Where
- 28 sites in Germany, Spain and 1 more
- Volunteers
- 303 people
- Sponsor
- Biotronik SE & Co. KG
Cardiovascular Disease
Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
The purpose of this clinical trial is to determine whether periodic therapy programming reports illustrating physician usage of shock reduction programming can increase utilization of recommended programming guidelines for…
- Trial name
- NCT00856349
- Testing
- Therapy Programming Report (TPR)
- Where
- 104 sites in United States, Argentina and 10 more
- Volunteers
- 4,384 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Sleep Apnoea
Ventricular Arrhythmias Incidence According to Sleep Apnea Syndrome in Implantable Cardioverter-Defibrillator (ICD) Patients
The purpose of this study is to report the incidence of ventricular arrhythmias correlated to the SAS and to focus on the interest of diagnosing Sleep-disorders breathing in ICD patients.
- Trial name
- NCT00708786
- Testing
- ICD, CRT-D
- Where
- 31 sites in France, Germany and 2 more
- Volunteers
- 755 people
- Sponsor
- LivaNova
Coronary Artery Disease
ST Monitoring to Detect Acute Coronary Syndrome Events in Implantable Cardioverter Defibrillator Patients
This is a prospective, non-randomized, multicenter, pivotal Investigational Device Exemption (IDE) study. The intent of this study is to demonstrate the safety and effectiveness of the ST Monitoring Feature in St Jude Medical ICD…
- Trial name
- AnalyzeST (NCT01424722)
- Testing
- Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices
- Where
- 97 sites in United States
- Volunteers
- 2,258 people
- Sponsor
- Abbott Medical Devices