Clinical trials: Sudden Death
Hunter Syndrome
An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment
This extension study of HGT-HIT-045 is designed to collect long-term safety data in pediatric participants with Hunter syndrome and cognitive impairment who are receiving intrathecal (IT) idursulfase-IT and intravenous (IV)…
- Trial name
- NCT01506141
- Testing
- Idursulfase-IT, Elaprase
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 15 people
- Sponsor
- Takeda
Heart Failure, Sudden Cardiac Death
CORE: Study to Evaluate the Conducted AF-Response-Algorithm in Patients Suffering From Heart Failure and Atrial Fibrillation
The Medtronic InSync III Marquis Cardiac Resynchronization Therapy Defibrillator (CRT-D)-System (implantable cardioverter-defibrillator with biventricular stimulation for cardiac resynchronization) is equipped with the…
- Conditions
- Heart Failure, Sudden Cardiac Death, Atrial Fibrillation
- Trial name
- NCT00170313
- Testing
- Conducted AF-Response Algorithm (CAFR) On, Conducted AF-Response Algorithm (CAFR) Off
- Where
- 7 sites in Germany
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Death, Sudden, Cardiac, Ventricular Fibrillation
DISCOVERY: Diagnostic Data and Genetic Polymorphisms in ICD Patients.
To prospectively evaluate if the analysis of genetic polymorphisms can be used to identify patients at risk of ventricular tachycardia.
- Conditions
- Death, Sudden, Cardiac, Ventricular Fibrillation, Tachycardia, Atrial Fibrillation
- Trial name
- DISCOVERY (NCT00478933)
- Testing
- Defibrillator, Dual Chamber ; Implantable, Blood sampling
- Volunteers
- 1,223 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Arrhythmogenic Cardiomyopathy, PKP2-ACM
A Study to Assess Real-world Patient Characteristics and Clinical Course for Symptomatic Patients With PKP2-ACM
An observational study to assess real-world patient characteristics and clinical course of disease in participants with PKP2-ACM.
- Conditions
- Arrhythmogenic Cardiomyopathy, PKP2-ACM, PKP2-ARVC
- Trial name
- SNAPSHOT- PKP2 (NCT06976606)
- Where
- 6 sites in United States
- Volunteers
- 40 people
- Sponsor
- Lexeo Therapeutics
Sudden Cardiac Death, Sudden Cardiac Arrest
Heart Failure Optimization Study
This study is designed as a multi-center prospective observational study of newly diagnosed Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF) recovery occurs between 90 and 180 days as…
- Conditions
- Sudden Cardiac Death, Sudden Cardiac Arrest, Heart Failure, Heart Failure Low Output
- Trial name
- HF-Opt (NCT03016754)
- Testing
- Wearable Cardioverter Defibrillator
- Where
- 67 sites in United States, Austria and 2 more
- Volunteers
- 602 people
- Sponsor
- Zoll Medical Corporation
Mucopolysaccharidosis Type II (MPS II)
CAMPSIITE™ RGX-121 Gene Therapy in Subjects With MPS II (Hunter Syndrome)
RGX-121 is a gene therapy which is intended to deliver a functional copy of the iduronate-2-sulfatase gene (IDS) to the central nervous system.
- Trial name
- NCT03566043
- Testing
- RGX-121
- Where
- 5 sites in United States, Brazil
- Volunteers
- 48 people
- Sponsor
- REGENXBIO Inc.
Mucopolysaccharidosis Type II (MPS II)
RGX-121 Gene Therapy in Children 5 Years of Age and Over With MPS II (Hunter Syndrome)
RGX-121 is a gene therapy which is designed to deliver a functional copy of the iduronate-2-sulfatase (IDS) gene to the central nervous system.
- Trial name
- NCT04571970
- Testing
- RGX-121
- Where
- 2 sites in United States, Canada
- Volunteers
- 6 people
- Sponsor
- REGENXBIO Inc.
Cardiopulmonary Failure, Myocardial Infarction (MI)
COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications Using COR ECG Wearable
The COR-INSIGHT trial aims to evaluate the effectiveness of Peerbridge COR advanced ambulatory ECG wearables (COR 1.0 and COR 2.0) in accurately and non-invasively detecting cardiovascular and cardiopulmonary conditions using…
- Conditions
- Cardiopulmonary Failure, Myocardial Infarction (MI), Heart Decompensation, Heart Failure
- Trial name
- COR-INSIGHT (NCT06763549)
- Testing
- SUBPROTOCOL A, SUBPROTOCOL B, SUBPROTOCOL C
- Where
- United States
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
Sudden Cardiac Death, Left Ventricular Dysfunction
LifeVest Safety and Efficacy in Real Life Settings in France
This post-market study is a prospective observational study evaluating the efficacy and safety of the LifeVest in real-life settings.
- Conditions
- Sudden Cardiac Death, Left Ventricular Dysfunction, Cardiac Event, Cardiac Arrythmias
- Trial name
- WEARIT-FR (NCT03319160)
- Testing
- Wearable Cardioverter Defibrillator
- Where
- 2 sites in France
- Volunteers
- 1,164 people
- Sponsor
- Zoll Medical Corporation
Sudden Cardiac Death
Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
The primary objective is to understand the role of antitachycardia pacing (ATP) in primary prevention patients indicated for implantable cardioverter-defibrillator (ICD) therapy and programmed according to current guidance of…
- Trial name
- APPRAISE ATP (NCT02923726)
- Testing
- Arm 1 (ATP+Shock), Arm 2 (shock only)
- Where
- 134 sites in United States, Austria and 6 more
- Volunteers
- 2,692 people
- Sponsor
- Boston Scientific Corporation
Mucopolysaccharidosis II
A Study of Potential Treatment-Responsive Biomarkers and Clinical Outcomes in Hunter Syndrome
This is a six-part prospective, multicenter, multiregional observational study of patients with mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome, to assess biomarkers potentially related to disease severity…
- Trial name
- NCT04007536
- Testing
- No Intervention
- Where
- 6 sites in United States, Netherlands and 1 more
- Volunteers
- 18 people
- Sponsor
- Denali Therapeutics Inc.
Hunter Syndrome
A Study of GC1111 in Hunter Syndrom Patients
The objective of this study is to evaluate the efficacy of GC1111 in Hunter Syndrome Patients
- Trial name
- NCT03920540
- Testing
- GC1111, Comparator
- Where
- South Korea
- Volunteers
- 32 people
- Sponsor
- Green Cross Corporation
Death, Sudden, Cardiac
ASSURE WCD Clinical Evaluation - Conversion Efficacy Study
A multicenter single arm open label evaluation of the ASSURE Wearable Cardioverter Defibrillator (WCD) defibrillation waveform in adult cardiac patients
- Trial name
- ACE-CONVERT (NCT04132466)
- Testing
- Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- Kestra Medical Technologies, Inc.
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
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.
Cardiac Rhythm Disorder, Heart Failure
Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.
- Conditions
- Cardiac Rhythm Disorder, Heart Failure, Sudden Cardiac Death
- Trial name
- PIANO (NCT05694572)
- Testing
- Implantation of a CIED
- Where
- Portugal
- Volunteers
- 2,500 people
- Sponsor
- MicroPort CRM
Sudden Cardiac Arrest, Acute Myocardial Infarction
Improve SCA Bridge Study
The purpose of the Improve SCA Bridge study is to characterize the care pathway flow of post-acute myocardial infarction (MI) patients as a result of standard assessments of left ventricular ejection fraction (LVEF) in the acute…
- Trial name
- NCT03715790
- Testing
- EP referred group, Non-Referred group
- Where
- 52 sites in Bangladesh, Brunei and 14 more
- Volunteers
- 1,491 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
Hurler Syndrome (MPS I), Hurler-Scheie Syndrome
Phase I/II Pilot Study of Mixed Chimerism to Treat Inherited Metabolic Disorders
The goal of this research study is to establish chimerism and avoid graft-versus-host-disease (GVHD) in patients with inherited metabolic disorders.
- Conditions
- Hurler Syndrome (MPS I), Hurler-Scheie Syndrome, Hunter Syndrome (MPS II), Sanfilippo Syndrome (MPS III)
- Trial name
- NCT01372228
- Testing
- hematopoietic stem cell infusion
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Talaris Therapeutics Inc.
Syncope
Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study
The purpose of this study is to conduct an observational investigation of a novel care path used to manage emergency department (ED) presenting syncope patients on an outpatient basis.
- Trial name
- ASAP (NCT02188147)
- Testing
- Short Term Wearable Defibrillator
- Where
- 6 sites in United States
- Volunteers
- 39 people
- Sponsor
- Zoll Medical Corporation