Clinical trials: ICD
Complication of Cardiac Defibrillator
Health Economic Evaluation of Remote Follow up for Implantable Cardioverter Defibrillator (ICD) Patients
The purpose of the study is to define the economic value of implantable cardioverter defibrillator (ICD) remote monitoring for hospitals, third payers and patients in Italy.
- Trial name
- TARIFF (NCT01075516)
- Where
- 6 sites in Italy
- Volunteers
- 209 people
- Sponsor
- Abbott Medical Devices
Congestive Heart Failure (CHF)
Clinical Evaluation of Cardiac Resynchronization Therapy (CRT) Using the Ovatio CRT Implantable Cardioverter-defibrillator (ICD) System
This study provides a continued access registry for cardiac resynchronization therapy with defibrillation (CRT-D), which helps to resynchronize (coordinate) the rhythm of the heart by helping the left ventricle contract (pump…
- Trial name
- NCT00528320
- Testing
- Ovatio CRT
- Sponsor
- ELA Medical, Inc.
Ventricular Fibrillation, Ventricular Tachycardia
SD01 Registry (SD01 ICD Lead)
This registry is designed to gather further evidence, in addition to the SD01 Master Study, for the safety and efficacy of the SD01 ICD lead.
- Conditions
- Ventricular Fibrillation, Ventricular Tachycardia, Heart Failure
- Trial name
- SD01 Registry (NCT02014675)
- Testing
- SD01 ICD lead
- Where
- 10 sites in Germany
- Volunteers
- 280 people
- Sponsor
- Biotronik SE & Co. KG
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
Magnetic Resonance Imaging
ENABLE MRI (Magnetic Resonance Imaging)
The objective of this study is to collect data to confirm the safety and effectiveness of the Image Ready™ MR (Magnetic Resonance) Conditional Defibrillation System when used in the 1.5T (Tesla) MRI environment under the labeled…
- Trial name
- ENABLE-MRI (NCT02652481)
- Testing
- ImageReady MR Conditional Defibrillation System
- Where
- 57 sites in United States, Belgium and 7 more
- Volunteers
- 500 people
- Sponsor
- Boston Scientific Corporation
Ventricular Tachycardia, Ventricular Fibrillation
DF4 Connector System Post-Approval Study
The purpose of this study is to evaluate long-term performance of the DF4 Connector System. This evaluation is based on the number of DF4 lead-related complications occurring during the study compared to the number of leads…
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Sudden Cardiac Death, Heart Failure
- Trial name
- NCT01638897
- Where
- 78 sites in United States, Canada and 1 more
- Volunteers
- 1,778 people
- Sponsor
- Medtronic
Ventricular Tachycardia, Ischemic
Early Ablation Therapy for the Treatment of Ischemic Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillators
The purpose of this study is to determine if early ablation (i.e., ablation of ventricular tachycardia in patients with infrequent VT episodes) is more effective than medical therapy alone for the treatment of ischemic…
- Trial name
- ASPIRE (NCT01557842)
- Testing
- Drug Treatment, Catheter Ablation
- Where
- 23 sites in United States
- Volunteers
- 15 people
- Sponsor
- Biosense Webster, Inc.
Heart Failure, Sudden Cardiac Death
Longitudinal Surveillance Registry
Boston Scientific CRM's Longitudinal Surveillance Registry (LSR) will serve as an active ongoing source of updated information on the long-term reliability and performance of BSC commercially available leads and LATITUDE-enabled…
- Trial name
- LSR (NCT00636272)
- Volunteers
- 2,500 people
- Sponsor
- Boston Scientific Corporation
ICD, Cardiomyopathy Ischemic
Assessment of Risk Factors for Appropriate ICD (Implantable Cardioverter-defibrillator) Intervention in Patients With Ischemic Cardiomyopathy
Design: PARCADIA is a prospective non-randomized non-interventional multi-center clinical investigation in Europe. Patients with depressed LV (left ventricular) function assessed on local standards, of ischemic origin and on…
- Conditions
- ICD, Cardiomyopathy Ischemic, Primary Prevention
- Trial name
- PARCADIA (NCT04014946)
- Testing
- ICD implantation
- Volunteers
- 200 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
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
Heart Failure
Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (HF) (REDUCEhf)
The purpose of this clinical research study is to evaluate the safety and effectiveness of the investigational implantable hemodynamic monitor (IHM), and of the IHM in combination with an implantable cardioverter defibrillator…
- Trial name
- REDUCEhf (NCT00354159)
- Testing
- Implantable Hemodynamic Monitor (Chronicle® IHM), and IHM in combination with single chamber ICD (Chronicle ICD)
- Where
- 52 sites in United States
- Volunteers
- 442 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Cardiomyopathy
InSync Implantable Cardioverter Defibrillator Registry: Cardiac Resynchronization Therapy
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
- NCT00289302
- Testing
- Cardiac resynchronization therapy device
- Where
- 51 sites in United States
- Volunteers
- 600 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Primary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest
S-ICD® System Post Approval Study
The purpose of the S-ICD Post Approval Study is to document long term safety and effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK electrode in a commercial clinical setting.
- Trial name
- NCT01736618
- Testing
- S-ICD System
- Where
- 87 sites in United States
- Volunteers
- 1,766 people
- Sponsor
- Boston Scientific Corporation
Implantable Defibrillator User
A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE Study
To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse VR ICD in an MRI environment.
- Trial name
- MRI Ready IDE (NCT02787291)
- Testing
- Ellipse VR ICD and Durata/Optisure lead
- Where
- 32 sites in United States, Hungary and 3 more
- Volunteers
- 227 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Tachyarrhythmia
Iperia/Sentus QP Study
The objective of this study is to confirm the safety and efficacy of the new Sentus OTW QP LV lead and Iperia ICD family. The study focuses on the safety and efficacy of the QP device system.
- Trial name
- NCT02181686
- Where
- 24 sites in Austria, Denmark and 9 more
- Volunteers
- 152 people
- Sponsor
- Biotronik SE & Co. KG
Inherited Metabolic Diseases, Lysosomal Storage Disorders
ALD-101 Adjuvant Therapy of Unrelated Umbilical Cord Blood Transfusion (UCBT) in Patients With Inherited Metabolic Diseases
Eligible research subjects will receive an unrelated umbilical cord blood transfusion as a possible cure for their inherited metabolic disease.
- Conditions
- Inherited Metabolic Diseases, Lysosomal Storage Disorders, Peroxisomal Storage Diseases, Inborn Errors of Metabolism
- Trial name
- UCBT-002 (NCT00654433)
- Testing
- ALD-101
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Aldagen
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
Safety of MR (Magnetic Resonance) Conditional CRT-pacemakers and ICDs
ProMRI PROVEN Master Study
This investigation is designed to provide supporting evidence for the clinical safety of the Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T (Heart Failure) triple chamber pacemaker…
- Trial name
- NCT01809665
- Testing
- ICD/CRT-P therapy, MRI
- Where
- 23 sites in Australia, Austria and 6 more
- Volunteers
- 174 people
- Sponsor
- Biotronik SE & Co. KG
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