Clinical trials: ICD Patients
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
Defibrillators, Tachycardia
Observational Study of Patient Comprehension, Perception, Fears and Appreciation Following Home-Monitoring Implementation
Describe the mutual influences between trainings realized in implantation centers, medico-technical knowledges, technical implementation, perception, fears and appreciation felt by the patients during Home Monitoring…
- Trial name
- Educ@t (NCT01006746)
- Testing
- Remote monitoring by Home Monitoring system
- Where
- France
- Volunteers
- 571 people
- Sponsor
- Biotronik France
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.
Arrhythmias, Cardiac
Full Early Atrial Diagnostics in Single Chamber ICD Patients Using the DX Lead and Home Monitoring in Brazil.
To demonstrate the value and benefits of BIOTRONIK's exclusive DX technology in assessing the incidence of supraventricular arrhythmias, mainly atrial fibrillation (AF), in patients with an indication for single chamber ICDs.
- Trial name
- SAFE-DX-Home (NCT04869527)
- Testing
- BIOTRONIK ICDs with DX Technology
- Where
- 2 sites in Brazil
- Volunteers
- 56 people
- Sponsor
- Biotronik SE & Co. KG
Tachycardia
Optimal Anti-tachycardia Therapy in Implantable Cardioverter-defibrillator (ICD) Patients Without Pacing Indications
This study evaluates the impact of a new pacing mode avoiding unnecessary ventricular stimulation in combination with advanced dual chamber detection with slow VT management on the clinical outcome for hospitalization and…
- Trial name
- OPTION (NCT00729703)
- Testing
- Ovatio DR 6550
- Where
- 55 sites in United States, Belgium and 7 more
- Volunteers
- 462 people
- Sponsor
- LivaNova
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
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
Cardiac Arrest
Quick ICD Study: Is Extensive Electrophysiological Testing Before, During and After ICD-Implantation Still Necessary ?
The purpose of this study is to evaluate the strategy of implanting an ICD with or without EPS before, during and after ICD-implantation in a randomised controlled trial, using a combined endpoint of major ICD-related adverse…
- Trial name
- Quick ICD (NCT00180362)
- Testing
- procedure
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Sudden Cardiac Death
Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications
The aim of the study is to assess the negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.
- Trial name
- Prediction (NCT00560768)
- Testing
- Ovatio VR 6250 or DR6550
- Where
- 30 sites in United States, Canada and 2 more
- Volunteers
- 198 people
- Sponsor
- LivaNova
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
Patients Indicated for an ICD
Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY)
The objective of this study is to confirm the long-term safety and reliability of the Linox Lead System as used with BIOTRONIK ICDs.
- Trial name
- GALAXY (NCT00836589)
- Testing
- ICD Therapy - ICD Lead Registry
- Where
- 85 sites in United States
- Volunteers
- 1,997 people
- Sponsor
- Biotronik, Inc.