Clinical trials: ICD Patients
Congestive Heart Failure
External Sensors for remoTe MoniToring of Heart Failure Patients With Implantable Defibrillators
This study has been designed to describe the use of Remote Patient Management (RPM) systems equipped with sensors for the measurement of weight and blood pressure in an Italian health care setting, verifying their efficacy and…
- Trial name
- ESTIMATE-HF (NCT02147340)
- Where
- Italy
- Volunteers
- 186 people
- Sponsor
- Maurizio Eugenio Landolina
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 Rate Control in ICD Patients With Heart Failure
Effect of Ivabradine and Beta-blockers Combination Versus Beta-blockers Up-titration on Right Ventricular Pacing
The aim of this prospective, randomized and controlled trial is to evaluate the use of the ivabradine in combination to a low-dose of beta-blocker (bisoprolol) versus up-titration of beta-blocker (bisoprolol) to obtain heart rate…
- Trial name
- NCT01868880
- Testing
- Ivabradine plus beta-blocker (bisoprolol), betablocker titration
- Where
- Italy
- Sponsor
- Policlinico Casilino ASL RMB
Electromagnetic Interference in Cardiovascular Implantable Electronic Device
Electromagnetic Interference and Automobile Remote Keyless Entry in Cardiovascular Implantable Electronic Device (CIED) Patients
Cardiovascular Implantable Electronic device (CIED) is a evolution therapy and number of patients with it are growing rapidly. Electromagnetic interference causing device malfunction is not uncommon, Radiofrequency Identification…
- Trial name
- NCT03016390
- Volunteers
- 100 people
- Sponsor
- Chiang Mai University
ICD, Cognitive Therapy
Screening and Intervention Reducing Anxiety in Patients With Implanted Cardioverter Defibrillator (ICD)
The hypothesis is that there is a significant difference in anxiety scores between intervention and usual care group after intervention.
- Conditions
- ICD, Cognitive Therapy, Anxiety
- Trial name
- NCT02713360
- Testing
- Cognitive Therapy
- Where
- 2 sites in Denmark
- Volunteers
- 88 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Implantable Defibrillator Lead Dysfunction, Implantable Automatic Defibrillator Malfunction
Shock Testing to Unmask RV Lead and GEnerator Malfunction in ICD Patients: the SURGE-ICD Registry
Shock testing during ICD generator replacement has been omitted by many centers. A previous study revealed lead failures in internally cardioverted patients with previously normal HV-lead values.
- Conditions
- Implantable Defibrillator Lead Dysfunction, Implantable Automatic Defibrillator Malfunction, Implantable Defibrillator User
- Trial name
- Surge-ICD (NCT04858672)
- Where
- Germany
- Volunteers
- 300 people
- Sponsor
- Universitätsklinikum Köln
Congestive Heart Failure
Compassionate Use Study of 125 mg Per Day of Azimilide Dihydrochloride in One Patient
This is an open-label, long term compassionate use study of 125 mg per day of azimilide 2HCl in a patient who completed two other protocols (2000098 and 2001060.
- Trial name
- NCT00752596
- Testing
- Azimilide 2HCl
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Forest Laboratories
Heart Failure and Reduced Ejection Fraction
Developing a Digital Aid to Improve ICD Decisions
Advanced heart failure, affecting 7 million Americans, has multiple causes and results in greatly increased risk of disability and death.
- Trial name
- NCT07084142
- Testing
- Online, patient-facing decision-making aid (app) with personalized risk information., Implantable Cardioverter Defibrillator (ICD), Online, patient-facing decision-making app without personalized risk information.
- Where
- 2 sites in United States
- Volunteers
- 600 people
- Sponsor
- Stanford University
Sudden Cardiac Death, Heart Failure
Educational Videos to Address Racial Disparities in Implantable Cardioverter Defibrillator Therapy
VIVID is a prospective, multicenter, randomized clinical trial in African American patients that will to evaluate: (1) the effect of an educational video on knowledge of sudden cardiac death (SCD) and implantable cardioverter…
- Trial name
- VIVID (NCT02819973)
- Testing
- Educational Video1, Educational Video 2, Usual Care 3
- Where
- 14 sites in United States
- Volunteers
- 343 people
- Sponsor
- Duke University
Cardiac Arrhythmias
The Efficacy of Adapted Yoga in Managing Psychosocial Risk in Implantable Cardioverter Defibrillator (ICD) Patients
Psychosocial risks are significant in the management of patients with cardiovascular disease and implantable cardioverter defibrillators (ICD) devices. This is a randomized, controlled, clinical study.
- Trial name
- NCT01716351
- Testing
- Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients
- Volunteers
- 55 people
- Sponsor
- Yale University
Ischaemic Heart Disease, Cardiac Arrhythmia
Effects of a Comprehensive Sexual Rehabilitation Programme in Heart Patients
The objective is to investigate the effect of a comprehensive sexual rehabilitation program, consisting of a psycho-educative component and a physical exercise component.
- Conditions
- Ischaemic Heart Disease, Cardiac Arrhythmia, Sexual Dysfunction
- Trial name
- CopenHeartSF (NCT01796353)
- Testing
- sexual rehabilitation, Usual care
- Where
- Denmark
- Volunteers
- 154 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Cardiac Arrhythmia, Ventricular Fibrillation
Emotional Regulation in Patients With Implanted Automatic Defibrillator
The general objective of the study was to evaluate the impact of two emotional regulation programs, one standardized and face-to-face (MBSR: Mindfulness Based Stress Reduction) and, another, implemented through a mobile phone…
- Conditions
- Cardiac Arrhythmia, Ventricular Fibrillation, Ventricular Tachycardia
- Trial name
- NCT04235881
- Testing
- Mindfulness-based stress reduction program, App REM volver a casa
- Where
- Spain
- Volunteers
- 96 people
- Sponsor
- Instituto de Investigación Hospital Universitario La Paz
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
Pacemaker, Implantable Cardioverter Defibrillators
Study Evaluating the Use of MRI on CMS Patients
The overall objective of this protocol is to evaluate the safety and utility of diagnostic MRI in Center for Medicare and Medicaid Services (CMS) beneficiaries with pacemakers and Implantable Cardioverter Defibrillators (ICD) and…
- Trial name
- PM/ICD (NCT02513056)
- Testing
- MRI
- Where
- United States
- Volunteers
- 872 people
- Sponsor
- University of Pennsylvania
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
Arrhythmias
Long Term Safety of 125 mg Per Day of Oral Azimilide in Patients With Implantable Cardioverter Defibrillator (ICDs)
This is an open-label, multi-center, long-term, (open-ended) safety study with 125 mg per day of azimilide in patients who completed protocol 2000098.
- Trial name
- NCT00751738
- Testing
- azimilide dihydrochloride
- Where
- 86 sites in United States, Belgium and 5 more
- Volunteers
- 330 people
- Sponsor
- Forest Laboratories
Myocardial Infarction, Sudden Cardiac Death
Personalised Risk scOre For Implantation of Defibrillators in Patients With Preserved LVEF>35% and a High Risk for Sudden Cardiac Death
The objective of the study is to demonstrate that in post-MI patients with preserved LVEF>35% but high risk for SCD according to a personalised risk score, the implantation of an ICD (index group) is superior to optimal medical…
- Trial name
- NCT04540289
- Testing
- Optimal Medical Therapy (OMT), Implantable cardioverter-defibrillator (ICD)
- Sponsor
- Helios Health Institute GmbH
Ischemic Cardiomyopathy, LV Dysfunction
Study to Compare TWA Test and EPS Test for Predicting Patients at Risk for Life-threatening Heart Rhythms (ABCD Study)
The ABCD clinical study is designed to determine if a T-Wave Alternans (TWA) test is equivalent to an Electrophysiology Study (EPS) in predicting life-threatening heart rhythms in patients with ischemic heart disease, left…
- Trial name
- NCT00187291
- Testing
- T-Wave Alternans test
- Volunteers
- 618 people
- Sponsor
- Abbott Medical Devices
ICD
Myocardial Injury in Patients With Cardiac Implantable Electronic Devices Undergoing Defibrillation Threshold Testing
Researchers are trying to determine if heart injury occurs in patients with a cardiac implantable electronic device (CIED) who undergo a defibrillation threshold testing (DFT) procedure.
- Trial name
- NCT04284800
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Mayo Clinic
Ventricular Tachycardia, Ventricular Fibrillation
Pediatric Lead Extractability and Survival Evaluation (PLEASE)
This is a randomized, prospective clinical trial comparing 2 different types of implantable cardioverter defibrillator (ICD) leads in children and patients with congenital heart disease.
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Cardiomyopathy, Long QT Syndrome
- Trial name
- NCT00335036
- Testing
- ICD lead implant, Thin leads
- Where
- United States
- Volunteers
- 748 people
- Sponsor
- Charles Berul