Clinical trials: ICD Implantation
Sudden Cardiac Death, Myocardial Infarction
Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation
Patients who have survived a myocardial infarction (MI) are at increased risk for sudden cardiac death (SCD) caused by ventricular tachycardia and ventricular fibrillation.
- Trial name
- PROFID EHRA (NCT05665608)
- Testing
- Implantable cardioverter-defibrillator (ICD), Optimal Medical Therapy (OMT)
- Where
- 86 sites in Austria, Belgium and 11 more
- Volunteers
- 3,595 people
- Sponsor
- Charite University, Berlin, Germany
Heart Diseases, Cardiac Disease
CIED Implantation in Low BMI Patients
The primary objective is to demonstrate a better degree of healing at the incision site and a decrease in erosion with CanGaroo compared to control patients (no envelope, CIED alone).
- Trial name
- NCT04299282
- Testing
- CanGaroo
- Sponsor
- Elutia Inc.
Acute STEMI, Severe Left Ventricular Systolic Dysfunction (Disorder)
Use of Cardiac MRI in Early Stages of STEMI to Predict Left Ventricular Function Recovery and ICD Implantation
Patients presenting with STEMI and late revascularization can suffer from severe left ventricular dysfunction. Midterm and longterm mortality can be determined by the risk of fatal ventricular arrythmias.
- Trial name
- STEMI-MR (NCT03743935)
- Testing
- Gadolinium-enhanced cardiac MRI
- Where
- France
- Volunteers
- 12 people
- Sponsor
- University Hospital, Montpellier
Pacemaker, Defibrillators, Implantable
Correct Mobilization Time After Implantation of an Intracardiac Electronic Device Implantation
Bedrest is usually prescribed for patients management after cardiac electronic device implantation (CIED) in order to prevent complication.
- Trial name
- NCT06330675
- Testing
- Early mobilization, Standard of care
- Where
- Switzerland
- Volunteers
- 558 people
- Sponsor
- Caporali Elena
Intraoperative Pain, Postoperative Pain
Truncal Blocks Versus Wound Infiltration for SICD
This is a single-center, randomized and prospective trial of all patients undergoing S-ICD implantation. Subjects will only be eligible for this study if they are ≥ 18 years of age and eligible to undergo S-ICD implant at Mount…
- Trial name
- NCT04974762
- Testing
- Wound infiltration, Truncal blocks
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Arrhythmia
Atorvastatin For The Reduction Of Ventricular Arrhythmias
To assess in patients with CAD [coronary artery disease] and an implantable defibrillator the effect of atorvastatin 80 mg versus placebo on the first recurrence of a ventricular arrhythmia (ventricular tachycardia or ventricular…
- Trial name
- CLARIDI (NCT00457340)
- Testing
- Atorvastatin 80mg
- Where
- 10 sites in Belgium, Greece
- Volunteers
- 220 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Cardiomyopathies, Cardiac Arrhythmias
UMBRELLA - Incidence of Arrhythmias in Spanish Population With a Medtronic Implantable Cardiac Defibrillator (ICD) Implant
The purpose of the study is to analyze the different patient profiles implanted with an Implantable Cardiac Defibrillator (ICD) in Spain (guidelines adoption) and the patient prognosis as a function of clinical profile, implant…
- Conditions
- Cardiomyopathies, Cardiac Arrhythmias, Cardiac Arrest
- Trial name
- UMBRELLA (NCT01561144)
- Where
- 51 sites in Spain
- Volunteers
- 4,648 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Cardiomyopathy, Coronary Artery Disease
Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the Elderly
The overall aim of this trial is to study the safety and efficacy of ICD implantation as a primary prevention strategy of sudden cardiac death in patients 70 years and older.
- Conditions
- Cardiomyopathy, Coronary Artery Disease, Congestive Heart Failure, Myocardial Infarction
- Trial name
- I-70 (NCT02121158)
- Testing
- Implantable Cardioverter Defibrillator, Optimal Medical Therapy
- Where
- 5 sites in United States
- Volunteers
- 167 people
- Sponsor
- VA Office of Research and Development
Quality of Life (QOL) and Impact of Stress
Quality of Life and the Influence of Stress on the Postoperative Course of Patients After Device Implantation
The project "Investigating Quality of Life and the Influence of Stress on the Postoperative Course of Patients After Device Implantation" aims to investigate the relationship between stress and the postoperative healing process…
- Trial name
- NCT07343466
- Testing
- Survey using a questionnaire.
- Where
- Germany
- Volunteers
- 300 people
- Sponsor
- University Hospital, Essen
Disorder of Cardiac Pacemaker System, Disorder of Implantable Defibrillator
Examination of Implant´s Safety in an Electronic and Magnetic Field Environment
The number of active electrical cardiac implants such as internal cardioverter defibrillators (ICDs), pacemakers or cardiac contractility modules (CCM) has significantly risen over the last two decades.
- Conditions
- Disorder of Cardiac Pacemaker System, Disorder of Implantable Defibrillator, Cardiac Arrhythmia
- Trial name
- FEMU (NCT01626261)
- Testing
- Magnetic and electric field´s impact on the implant
- Where
- Germany
- Volunteers
- 281 people
- Sponsor
- RWTH Aachen University
Non-ischemic Dilated Cardiomyopathy
Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy
Patients with diagnostic CMR images for assessment of LGE/fibrosis and evidence/presence of non-ischaemic myocardial fibrosis/scar will be randomized to the following treatment groups in a 1:1 ratio: ICD group or Optimal HF care…
- Trial name
- CMR-ICD (NCT04558723)
- Testing
- ICD/CRT-D implantation
- Where
- Germany
- Volunteers
- 760 people
- Sponsor
- Prof. Dr. med. Ingo Eitel
Cardiomyopathy
Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies
This is a pilot study to find a correlation between MRI and ICD therapy in patients with known cardiomyopathies, aiming to determine if cardiac scarring identified by MRI correlates with ventricular arrhythmias and the occurrence…
- Trial name
- NCT00312624
- Testing
- contrast-enhanced cardiac MRI
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
Sudden Cardiac Death
TroponinT After Subcutaneous Cardioverter-Defibrillator Implantation
Serum Troponin levels pre- and postoperatively will be compared in patients receiving an entirely subcutaneous cardioverter-defibrillator.
- Trial name
- TROPIC (NCT03526302)
- Where
- Germany
- Volunteers
- 43 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Tachycardia, Ventricular
Bispectral Index Monitoring During Testing in the Electrophysiology Lab
BACKGROUND Physician-guided moderate sedation, administered by a Registered Nurse has been the standard of practice for patients undergoing a wide range of electrophysiology procedures during the past decade.
- Trial name
- NCT00749671
- Testing
- Bispectral index monitoring, Ramsey Sedation Scale
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Baystate Medical Center
Blood Pressure
Predicting Blood Pressure in Patients Following Defibrillation
During tachyarrhythmias, central venous pressures increases while arterial blood pressure (BP) decreases. The result is mixed messages to the central nervous system.
- Trial name
- NCT02686307
- Testing
- ICD Implant
- Volunteers
- 33 people
- Sponsor
- University of Utah
Ventricular Fibrillation, Ventricular Flutter
SAFEty of Two Strategies of ICD Management at Implantation
The aim of this prospective observational study is to evaluate the safety, over a follow-up of 2 years, of two strategies, consisting in performing or not performing defibrillation testing(DT) during first implant of implantable…
- Conditions
- Ventricular Fibrillation, Ventricular Flutter, Sudden Cardiac Death
- Trial name
- SAFE-ICD (NCT00661037)
- Testing
- Implantable defibrillator
- Where
- Italy
- Volunteers
- 2,120 people
- Sponsor
- Boston Scientific Corporation
Cardiac Arrest, Heart Arrest
ICD Shock Detection by a Wearable
Trial to assess the ability of a wearable to detect defibrillation from an implantable ICD
- Conditions
- Cardiac Arrest, Heart Arrest, Cardiopulmonary Arrest
- Trial name
- LOISICD (NCT04565652)
- Testing
- Device Wearers
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Lois Medical LTD
Heart Disease, Implantable Cardioverter Defibrillator (ICD)
Optimal Settings for Anti Tachycardia Pacing (ATP) on ICD
This is a pragmatic, two-group, cluster randomized trial designed to compare strategies for the Anti Tachycardia Pacing (ATP)-setting in the ventricular tachyarrhythmias (VT) zone when implanting a new implantable cardioverter…
- Conditions
- Heart Disease, Implantable Cardioverter Defibrillator (ICD), Heart Rhythm Disorders, Ventricular Tachyarrhythmias
- Trial name
- DAN-ATP (NCT07354347)
- Testing
- Burst, Ramp
- Where
- Denmark
- Volunteers
- 3,980 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Heart Failure
Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry
MADIT-CRT PAR is an FDA mandated follow-up registry for patients that participated in the MADIT-CRT IDE study examining long-term mortality. (MADIT-CRT IDE: NCT00180271)
- Trial name
- MADIT-CRT PAR (NCT01294449)
- Testing
- MADIT-CRT ICD, MADIT-CRT CRT-D
- Where
- United States
- Volunteers
- 394 people
- Sponsor
- Boston Scientific Corporation