Clinical trials: Implantable Cardioverter Defibrillator
Ventricular Tachycardia (VT)
Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)
Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and treated with the…
- Trial name
- NCT06703489
- Testing
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
Focus Whether After Implant Pre-AICD Video Was Helpful
LifeSkills Video Training in Patients About to Receive an Automatic Implantable Cardioverter-Defibrillator (AICD)
The purpose of this trial was to develop the initial sections of a video/DVD cassette that provided guidance about mastering stressful situations for patients who had been informed that they need an implantable…
- Trial name
- AICD (NCT01686490)
- Testing
- Video/workbook for patients about to receive an AICD, LiveSkills Video/Workbook for patients about to receive an AICD
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Williams LifeSkills
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
Ventricular Tachycardia
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Sphere VT is a prospective, multi-center, single-arm, unblinded pivotal clinical study. Adult subjects with recurrent, sustained, monomorphic ventricular tachycardia (MMVT) due to prior myocardial infarction (MI) will be enrolled…
- Trial name
- NCT07585968
- Testing
- Sphere-9 Catheter with the Affera Mapping and Ablation System
- Where
- 7 sites in United States
- Volunteers
- 260 people
- Sponsor
- Medtronic Cardiac Ablation Solutions
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
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
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
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 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
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
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
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
ICD, Sudden Cardiac Death
Ability of Home Monitoring® to Detect and Manage the Inappropriate Diagnoses in Implantable Cardioverter Defibrillators.
The purpose of the THORN registry is to show the ability of Home-Monitoring® to early identify and manage the inappropriate diagnoses of ventricular arrhythmia in ICD patients (i.e.
- Conditions
- ICD, Sudden Cardiac Death, Ventricular Fibrillation, Atrial Fibrillation
- Trial name
- THORN (NCT01594112)
- Where
- 55 sites in France
- Volunteers
- 512 people
- Sponsor
- Biotronik SE & Co. KG
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
Implantable Defibrillator User
Plexa ICD Lead Registry
The purpose of this registry is to confirm the long-term safety and reliability of BIOTRONIK's Plexa ICD lead.
- Trial name
- NCT03103503
- Where
- 28 sites in United States
- Volunteers
- 901 people
- Sponsor
- Biotronik, Inc.
Tachycardia, Ventricular Arrythmia
ExtraVascular Implantable Cardioverter Defibrillator (EV ICD) Japan Study
The study is designed to characterize the acute safety and performance of the EV ICD System for Japanese patients.
- Trial name
- NCT07091916
- Testing
- Defibrillation using the Extravascular ICD
- Where
- Japan
- Volunteers
- 14 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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.
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