Clinical trials: Implantable Cardioverter-Defibrillator
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
Tachycardia
Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators
The purpose of this clinical investigation is the continued assessment of the decision accuracy of St. Jude Medical (SJM) ICD with enhanced SVT discriminators in the treatment of subjects with primary and secondary prevention of…
- Trial name
- ReduceIT (NCT01963286)
- Testing
- ICD with enhanced SVT discriminators
- Where
- 23 sites in Estonia, Germany
- Volunteers
- 735 people
- Sponsor
- Abbott Medical Devices
Tachycardia
INTRINSIC RV - Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs
INTRINSIC RV is a two-armed randomized trial that will compare the effects of innovative dual-chamber pacing with AV Search Hysteresis to standard VVI among ICD patients.
- Trial name
- NCT00148967
- Testing
- Implantable Cardioverter Defibrillator
- Volunteers
- 1,535 people
- Sponsor
- Boston Scientific Corporation
Arrhythmia, Sinus Node Disease
PANORAMA Observational Study
To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic implantable pacemakers and cardioverter defibrillators (both with or without cardiac resynchronization therapy)…
- Conditions
- Arrhythmia, Sinus Node Disease, Heart Failure, Heart Block
- Trial name
- NCT00382525
- Testing
- Cardiac Rhythm Management device
- Where
- 27 sites in Belgium, India and 4 more
- Volunteers
- 8,586 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiac Implantable Electronic Device Infection
TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD
The purpose of this study is to compare the incidence of cardiac implantable electronic device (CIED) infection and CIED mechanical complication after CIED replacement with a high-power cardiac implantable electronic device…
- Trial name
- Centurion (NCT01043705)
- Where
- 52 sites in United States
- Volunteers
- 1,262 people
- Sponsor
- TYRX, Inc.
Tachycardia, Ventricular
SMS: Substrate Modification Study in Patients Getting an Implantable Cardioverter Defibrillator (ICD)
The present standard of care for the management of unstable ventricular tachycardia (VT) in the setting of chronic coronary artery disease is the placement of an implantable cardioverter defibrillator (ICD) after the initial…
- Trial name
- SMS (NCT00170287)
- Testing
- ICD Ablation plus VT-ablation, ICD Therapy
- Where
- 7 sites in Denmark, Germany
- Volunteers
- 116 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiovascular Disease
Medtronic Shock-Less Study on Physician Utilization of Shock Reduction Programming
The purpose of this clinical trial is to determine whether periodic therapy programming reports illustrating physician usage of shock reduction programming can increase utilization of recommended programming guidelines for…
- Trial name
- NCT00856349
- Testing
- Therapy Programming Report (TPR)
- Where
- 104 sites in United States, Argentina and 10 more
- Volunteers
- 4,384 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure
The purpose of this clinical study is to estimate the safety and radiation dosimetry of a single dose of LMI1195 in healthy subjects and heart failure patients undergoing positron emission tomography (PET)
- Trial name
- NCT00891241
- Testing
- LMI 1195-101
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Lantheus Medical Imaging
Heart Failure
CareLink® Network Evaluation
The purpose of the study is to demonstrate the value of the Medtronic CareLink® Network in clinical practice in the country specific healthcare setting.
- Trial name
- NCT01023022
- Testing
- Medtronic CareLink® Network
- Where
- 10 sites in Poland
- Volunteers
- 176 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
ICD and CRT-D Indicated Patients
The 4-SITE Field Following Study (4-SITE FF)
The purpose of this study is to evaluate and document appropriate clinical performance of the new 4-SITE Header / Lead interface in the TELIGEN 100 HE 4-SITE (VR and DR) implantable cardioverter defibrillator (ICD) PGs (Models…
- Trial name
- 4-SITE FF (NCT00920452)
- Where
- Germany
- Volunteers
- 430 people
- Sponsor
- Guidant Corporation
Heart Failure, Congestive
PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure
The purpose of this study is to determine the value of diagnostic data obtained from Medtronic implantable cardioverter defibrillators (ICDs) with cardiac resynchronization therapy (CRT) to evaluate cardiovascular and heart…
- Trial name
- NCT00279955
- Testing
- Cardiac Resynchronization Therapy Device
- Where
- 93 sites in United States
- Volunteers
- 1,024 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
ACC/AHA/NASPE Class 1, IIa or IIb Indications
Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
The primary objective is to evaluate the S-ICD system's ability to identify and terminate induced ventricular fibrillation in patients during the implant procedure.
- Trial name
- NCT01117792
- Testing
- subcutaneous implantable defibrillator (S-ICD) system
- Where
- 8 sites in Italy, Netherlands and 2 more
- Volunteers
- 55 people
- Sponsor
- Boston Scientific Corporation
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
Ventricular Arrythmias
Efficacy of the ATP Switch Automatic Programming in Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) Implanted Patients
Primary objective is to assess the efficacy of the new ATP Autoswitch function in simple, dual or triple chamber ICD.
- Trial name
- ASAP (NCT01169246)
- Where
- France
- Volunteers
- 1,254 people
- Sponsor
- MicroPort CRM
Sudden Cardiac Death, Heart Failure
Next Generation INCEPTA Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT-D) Field Following Study
This study has 2 purposes: The first purpose of the study is to test a new family of Boston Scientific Implantable Cardioverter Defibrillators ("ICDs") and cardiac resynchronization therapy ICDs ("CRT-Ds") and show how well these…
- Trial name
- NOTICE-HF (NCT01227785)
- Testing
- INCEPTA ICD or CRT-D
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- Guidant Corporation
Arrhythmia, Quality of Life
Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function (QUANTUM)
Quality of life (QOL) and psychological well-being of patients with implantable cardioverter-defibrillators (ICDs) are significantly influenced by the experience of shock therapies.
- Trial name
- NCT00325221
- Testing
- HM on, HM Off
- Where
- 7 sites in Austria, Germany and 1 more
- Volunteers
- 148 people
- Sponsor
- Biotronik SE & Co. KG
Arrhythmia, Cardiac
Surface Electrocardiogram (ECG) Signal Recording for Implantable Subcutaneous String Defibrillator (ISSD) Development
Record cutaneous Electrocardiogram (ECG) data from positions corresponding to the expected subcutaneous locations of the Implantable Subcutaneous String Defibrillator (ISSD) using existing, approved ECG recording devices.
- Trial name
- NCT02991716
- Testing
- recorded patients
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- NewPace Ltd
Ventricular Fibrillation, Ventricular Tachycardia
Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function
Re-hospitalizations or deaths by worsening heart failure are often preceded by distinct trends of clinical parameters such as atrial or ventricular arrhythmia, activity, heart rate variability, or ventricular ectopy.
- Conditions
- Ventricular Fibrillation, Ventricular Tachycardia, Congestive Heart Failure
- Trial name
- IN-TIME (NCT00538356)
- Testing
- ICD or CRT-D with Home Monitoring feature deactivated, ICD or CRT-D with Home Monitoring feature activated
- Where
- 39 sites in Australia, Austria and 5 more
- Volunteers
- 720 people
- Sponsor
- Biotronik SE & Co. KG
Cardiac Pacing, Electric Countershock
Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)
Patients with implantable cardioverter defibrillators (ICDs) should undergo regular device follow-ups every 3 months, to verify proper ICD function.
- Conditions
- Cardiac Pacing, Electric Countershock, Ventricular Tachyarrhythmia
- Trial name
- ANVITE (NCT00858559)
- Testing
- Implantable cardioverter defibrillator with Home Monitoring function, Standard implantable cardioverter defibrillator
- Where
- Germany
- Volunteers
- 110 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure, Defibrillators, Implantable
Precision Event Monitoring for Patients With Heart Failure Using HeartLogic
The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an…
- Conditions
- Heart Failure, Defibrillators, Implantable, Monitoring, Physiologic, Cardiac Resynchronization Therapy
- Trial name
- PREEMPT-HF (NCT03579641)
- Testing
- HeartLogic Sensors
- Where
- 88 sites in United States, Australia and 11 more
- Volunteers
- 2,184 people
- Sponsor
- Boston Scientific Corporation