Clinical trials: Implantable Cardiac Defibrillator
Congestive Heart Failure, Coronary Artery Disease
MYOHEART™ (Myogenesis Heart Efficiency and Regeneration Trial)
The MyoCell™ implantation using the MyoCath™ delivery catheter system may have the potential to add a new dimension to the management of post-infarct deterioration of cardiac function in subjects with congestive heart failure.
- Conditions
- Congestive Heart Failure, Coronary Artery Disease, Myocardial Infarction
- Trial name
- NCT00054678
- Testing
- MyoCell™, MyoCath™
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Bioheart, Inc.
Tachycardia, Ventricular Arrythmia
ExtraVascular Implantable Cardiac Defibrillator Continued Access Study
This study is designed to provide continued access to the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.
- Trial name
- EV ICD CA (NCT05049720)
- Testing
- Defibrillation using the Extravascular ICD
- Sponsor
- Medtronic
Ventricular Tachyarrhythmias
Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system.
- Trial name
- Chronic II (NCT00853645)
- Testing
- Subcutaneous Implantable Defibrillator (S-ICD) System
- Where
- 2 sites in New Zealand
- Volunteers
- 6 people
- Sponsor
- Boston Scientific Corporation
Tachycardia, Ventricular, Ventricular Fibrillation
ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
The purpose of this study is to estimate and quantify the difference in efficacy of two sequences of ATP therapies (burst 15 pulses, 88% versus burst 8 pulses, 88%) during an episode of spontaneous rhythms classified as fast…
- Trial name
- ADVANCE_D (NCT00147277)
- Testing
- Implantable Cardiac Defibrillator
- Where
- Italy
- Volunteers
- 925 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, 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
Monomorphic Ventricular Tachycardia
Evaluation of Inducible Monomorphic Ventricular Tachycardia (MMVT) in Patients With St. Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) Systems or Cardiac Resynchronization Therapy Defibrillation (CRT-D) Systems.
The intent of this observational study is to understand the role of non-invasive programmed stimulation (NIPS) to induce substrate based MMVT (Monomorphic Ventricular Tachycardia) in patients receiving new St.
- Trial name
- EPIC (NCT02584595)
- Testing
- ICD/CRT-D with NIPS or EP Study
- Sponsor
- Abbott Medical Devices
Bradycardia, Sudden Cardiac Arrest
Feasibility Study of Remote Support for Implantable Pulse Generator (IPG)/Implantable Cardioverter Defibrillator (ICD) Implant
The purpose of this study is to gain real world, live implant experience with the remote implant support system. This system is intended to provide the technical support for device implants from a remote location through…
- Trial name
- NCT01809652
- Testing
- Remote Implant Support Capability
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Atrial Fibrillation, Atrial Flutter
Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Stroke, Embolism, Systemic Arterial
- Trial name
- IMPACT (NCT00559988)
- Testing
- Home Monitoring Guided OAC, Physician-Directed OAC
- Where
- 80 sites in United States, Australia and 4 more
- Volunteers
- 2,718 people
- Sponsor
- Biotronik, Inc.
Tachyarrhythmia
Full Automaticity and Remote Follow-up
With the expansion of Sudden Cardiac Death (SCD) primary prevention indications, the number of Implantable Cardioverter Defibrillators (ICD) implants has increased significantly in the recent years.
- Trial name
- NCT01526629
- Where
- France
- Volunteers
- 354 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
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
Tachyarrhythmia, Arrhythmias, Cardiac
Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment
Recorded cutaneous ECG containing arrhythmia events are separately analysed by an expert Electrophysiologist and the ISSD detection algorithm, to allow assessment of the correct detection of tachyarrhythmia events and…
- Trial name
- NCT03408951
- Testing
- Recording
- Where
- United States
- Volunteers
- 91 people
- Sponsor
- NewPace Ltd
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
Myocardial Infarction, Arrhythmia, Ventricular
MASTER I - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients
The purpose of the study is to determine the usefulness of microvolt T wave alternans (MTWA) testing of patients that have had a heart attack and have decreased pumping ability of the lower chamber of their heart.
- Conditions
- Myocardial Infarction, Arrhythmia, Ventricular, Ischemic Cardiomyopathy
- Trial name
- NCT00305240
- Testing
- T Wave Alternans Test
- Where
- 47 sites in United States
- Volunteers
- 656 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tachycardia, Ventricular, Ventricular Fibrillation
ADVANCE CRT - D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
To compare the efficacy of RV and BiV ATP for the termination of ventricular arrhythmias in patients who are candidates to a cardiac resynchronisation therapy (CRT) and have a Class I or IIA indication for ICD implantation.
- Trial name
- ADVANCE-CRTD (NCT00147290)
- Testing
- Implantable Cardiac Defibrillator
- Where
- Italy
- Volunteers
- 526 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Tachycardia
Safety and Performance Study of the Reliance 4-Front Lead
The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Active Fixation Defibrillation Leads.
- Trial name
- NCT01772576
- Testing
- Reliance 4-Front lead implantation
- Where
- 15 sites in Austria, China and 9 more
- Volunteers
- 167 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
Cardiac Arrhythmia
SJM MRI Diagnostic Imaging Registry (IDE)
This study is a prospective, non-randomized, multi-center study of subjects implanted with an SJM pacemakers, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices who are clinically…
- Trial name
- NCT02807948
- Testing
- Pacemaker, ICD, or CRT device
- Where
- 58 sites in United States
- Volunteers
- 189 people
- Sponsor
- Abbott Medical Devices
Cardiac Death
Reduction of Inappropriate Implantable Cardioverter Defibrillator (ICD) Therapies in Primary Prevention Patients
The purpose of this study is to determine efficacy of a dedicated programming concept for avoidance of inappropriate implantable cardioverter defibrillator (ICD) therapies in patient with primary prevention ICD indication.
- Trial name
- DECREASE (NCT01217528)
- Testing
- device settings for group A, Device settings for group B
- Where
- 34 sites in Germany
- Volunteers
- 543 people
- Sponsor
- Abbott Medical Devices