Clinical trials: Sudden Death
Sudden Cardiac Arrest
Jewel Electrophysiology (EP) Lab Study
Single arm open label evaluation of the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) defibrillation waveform in adult cardiac patients.
- Trial name
- NCT05490459
- Testing
- Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)
- Where
- Czechia
- Volunteers
- 18 people
- Sponsor
- Element Science, Inc.
Ventricular Tachycardia, Ventricular Fibrillation
DF4 Master Study (Safety and Efficacy Study)
The purpose of the study is to proof the safety and efficacy of the new ICD sytem (Iforia/Ilesto). The devices are available with DF-1 and DF4 connection. A special focus is set on the ICD system with DF4 connection.
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Sudden Cardiac Death, Heart Failure
- Trial name
- NCT01790841
- Testing
- Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego
- Where
- Germany
- Volunteers
- 240 people
- Sponsor
- Biotronik SE & Co. KG
Sudden Cardiac Death
Comparison of 50% Tilt and Tuned Waveforms in Single-Coil Active Can Configuration
The purpose of this study is to compare the defibrillation efficacy between the 50/50% tilt biphasic waveform and the Tuned biphasic waveform in a single coil active can configuration.
- Trial name
- PROMISE (NCT00874445)
- Testing
- ICD/ CRT-D
- Where
- United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
Long QT Syndrome Type 3
Effect of Eleclazine on Shortening of the QT Interval, Safety, and Tolerability in Adults With Long QT Syndrome Type 3
The primary objective of this study is to evaluate the effect of oral eleclazine on mean daytime QTcF interval after 24 weeks of treatment with elecalzine in participants with long QT syndrome Type 3.
- Trial name
- NCT02300558
- Testing
- Eleclazine
- Where
- 12 sites in United States, Canada and 6 more
- Volunteers
- 41 people
- Sponsor
- Gilead Sciences
Hunter Syndrome
An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients
The objective of this study is to evaluate the effect of anti-idursulfase antibodies on idursulfase safety (measured by infusion related adverse events) between patients who develop anti-idursulfase antibodies and patients who do…
- Trial name
- NCT00882921
- Testing
- Idursulfase
- Where
- 6 sites in United States, Brazil and 1 more
- Volunteers
- 26 people
- Sponsor
- Shire
Arrhythmias, Cardiac
Evaluating the Risk of Serious Ventricular Arrhythmia and Sudden Cardiac Death Among Users of Domperidone
The purpose of this retrospective observational study is to obtain information to confirm or contradict the results of prior studies on domperidone and sudden cardiac death.
- Trial name
- NCT00925457
- Testing
- No Intervention, Current Domperidone, Current proton pump inhibitor (PPI)
- Volunteers
- 1,608 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sudden Cardiac Arrest
HeartStart FRx Defibrillator Event Registry
This post market clinical follow-up study is a multi-center, non-randomized, unblinded, observational registry of the performance of the FRx Automated external defibrillator (AED) used in conjunction with electrodes with or…
- Trial name
- NCT04250857
- Testing
- HeartStart FRX
- Where
- United States
- Volunteers
- 1,400 people
- Sponsor
- Heartstream US LLC
Arrhythmogenic Cardiomyopathy, PKP2-ACM
Gene Therapy for ACM Due to a PKP2 Pathogenic Variant
This is a Phase 1/2, first-in-human, open-label, intravenous, dose-escalating, multicenter trial that is designed to assess the safety and tolerability of LX2020 in adult patients with PKP2-ACM
- Conditions
- Arrhythmogenic Cardiomyopathy, PKP2-ACM, PKP2-ARVC
- Trial name
- NCT06109181
- Testing
- LX2020
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- Lexeo Therapeutics
Bradycardia, Sudden Cardiac Arrest
Feasibility Study of Remote Support for Implantable Pulse Generator (IPG)/Implantable Cardioverter Defibrillator (ICD) Implant
The purpose of this study is to gain real world, live implant experience with the remote implant support system. This system is intended to provide the technical support for device implants from a remote location through…
- Trial name
- NCT01809652
- Testing
- Remote Implant Support Capability
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Mucopolysaccharidosis II
Safety and Efficacy of HMI-203 in ERT-Treated Adults With MPS II
Phase 1, open-label, sequential ascending dose-escalation study. Designed to evaluate the safety and efficacy of a single IV infusion of investigational gene therapy HMI-203.
- Trial name
- NCT05238324
- Testing
- Genetic HMI-203
- Where
- 6 sites in United States, Canada
- Sponsor
- Homology Medicines, Inc
Sudden Cardiac Arrest
HeartStart HS1 Defibrillator* Event Registry
A Prospective study on the performance and safety of the HeartStart OnSite (Model M5066A) \& HeartStart Home (Model M5068A) Defibrillator device data.
- Trial name
- NCT04840797
- Testing
- HeartStart HS1
- Where
- United States
- Volunteers
- 1,400 people
- Sponsor
- Heartstream US LLC
Mucopolysaccharidosis II
Long-term Follow-Up for RGX-121
RGX-121-5101 is an observational long-term follow-up study to the RGX-121-101 or RGX-121-1102 studies where participants received RGX-121, a gene therapy intended to deliver a functional copy of the iduronate-2-sulfatase gene…
- Trial name
- NCT04597385
- Testing
- Long-term Follow-Up
- Where
- 4 sites in United States, Brazil
- Volunteers
- 27 people
- Sponsor
- REGENXBIO Inc.
Sudden Cardiac Arrest
The Jewel IDE Study
The Jewel IDE Study: A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest. ("JEWEL")
- Trial name
- NCT05201495
- Testing
- Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)
- Where
- 30 sites in United States
- Volunteers
- 322 people
- Sponsor
- Element Science, Inc.
Hunter Syndrome, Mucopolysaccharidosis II (MPS II)
Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase
Study TKT024EXT was a long-term, single-arm, open-label extension of Study TKT024, a one year Phase 2/Phase 3 registration study.
- Trial name
- NCT00630747
- Testing
- Idursulfase
- Where
- 52 sites in United States, Brazil and 8 more
- Volunteers
- 94 people
- Sponsor
- Shire
Sudden Cardiac Arrest, Emergency Care
Tempus Pro Monitor Registry
A multicenter, prospective and retrospective, observational, post market study.
- Trial name
- NCT05587764
- Testing
- Standard of Care
- Where
- United States
- Volunteers
- 103 people
- Sponsor
- Heartstream US LLC
Sudden Cardiac Arrest, Ventricular Arrythmia
Improve Sudden Cardiac Arrest Study
The purpose of this study is to demonstrate that primary prevention patients with one or more additional risk factors (1.5 prevention criteria: syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent…
- Trial name
- NCT02099721
- Testing
- ICD or CRT-D Device
- Where
- 93 sites in Argentina, Belarus and 14 more
- Volunteers
- 4,222 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Cardiac Arrest, Sudden
ASSURE WCD Clinical Evaluation - Detection and Safety Study
A prospective multicenter single arm open label study to evaluate ambulatory detection performance, arrhythmia detection and safety of the ASSURE™ Wearable Cardioverter Defibrillator (WCD).
- Trial name
- ACE-DETECT (NCT03887052)
- Testing
- ASSURE™ Wearable Cardioverter Defibrillator (WCD)
- Where
- 10 sites in United States
- Volunteers
- 130 people
- Sponsor
- Kestra Medical Technologies, 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