Clinical trials: Sudden Death
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
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
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
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.
Mucopolysaccharidosis II, MPS II
Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-913 in Subjects With MPS II
The purpose of the study is to evaluate the safety, tolerability and effect on leukocyte and plasma Iduronate 2-Sulfatase (IDS) enzyme activity of ascending doses of SB-913.
- Trial name
- NCT03041324
- Testing
- SB-913
- Where
- 5 sites in United States
- Volunteers
- 9 people
- Sponsor
- Sangamo Therapeutics
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
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
Hunter Syndrome
Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment
Study HGT-HIT-094 is a multicenter study designed to determine the effect on clinical parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg for 12 months in pediatric patients with Hunter…
- Trial name
- AIM-IT (NCT02055118)
- Testing
- idursulfase-IT, No IT treatment
- Where
- 9 sites in United States, Australia and 5 more
- Volunteers
- 58 people
- Sponsor
- Shire
LQT2 Syndrome
Study to Evaluate the Effect of Eleclazine on QT, Safety, and Tolerability in Participants With Long QT2 Syndrome
The primary objective of the study is to evaluate the effect of oral eleclazine (formerly GS-6615) on corrected QT (QTc) interval in participants with long QT2 syndrome.
- Trial name
- NCT02365506
- Testing
- Eleclazine
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Gilead Sciences
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.
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
Sudden Cardiac Death, Sudden Cardiac Arrest
Wearable Cardioverter Defibrillator in Hemodialysis Patients (WED-HED) Study
A multi-center, prospective, randomized controlled clinical trial with 1:1 assignment of treatment and control. This study will evaluate the impact of wearable cardioverter defibrillator use on sudden cardiac death in incident…
- Trial name
- WED-HED (NCT02481206)
- Testing
- Wearable Cardioverter Defibrillator
- Where
- 31 sites in United States
- Volunteers
- 66 people
- Sponsor
- Zoll Medical Corporation
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
Heart Arrest, Death, Sudden, Cardiac
ResQ Trial: Impact of an ITD and Active Compression Decompression CPR on Survival From Out-of-Hospital Cardiac Arrest
The purpose of this study is to determine whether performing active compression decompression cardiopulmonary resuscitation (ACD-CPR) with an impedance threshold device (ITD) compared to conventional standard cardiopulmonary…
- Conditions
- Heart Arrest, Death, Sudden, Cardiac, Cardiopulmonary Resuscitation, Cardiac Arrest
- Trial name
- ResQ (NCT00189423)
- Testing
- Use of an impedance threshold device (ITD) during the performance of active compression decompression CPR (ACD-CPR), Standard cardiopulmonary resuscitation (S-CPR)
- Where
- 7 sites in United States
- Volunteers
- 1,653 people
- Sponsor
- Advanced Circulatory Systems
Hunter Syndrome
A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®
Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously.
- Trial name
- NCT00920647
- Testing
- Control, Idursulfase IT (1 mg), Idursulfase IT (10 mg)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Shire
Sudden Cardiac Death
POWER (Pulse Width Optimized Waveform Evaluation Trial)
The objective of this study is to compare the ULV (Upper Limit of Vulnerability)/DFT (Defibrillation Threshold) efficacy between the 2.5, 3.5 and 4.5 ms membrane time constant based biphasic defibrillation waveforms.
- Trial name
- NCT00311181
- Testing
- Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT-D)
- Where
- 2 sites in United States
- Volunteers
- 217 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Left Ventricular Dysfunction
DEfibrillators To REduce Risk by MagnetIc ResoNance Imaging Evaluation
This trial is a prospective, multi-center, randomized study of patients with coronary artery disease (CAD) and mild to moderate left ventricular (LV) dysfunction.
- Conditions
- Coronary Artery Disease, Left Ventricular Dysfunction, Sudden Cardiac Death
- Trial name
- DETERMINE (NCT00487279)
- Testing
- Defibrillator, Control
- Where
- 56 sites in United States
- Volunteers
- 81 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Arrhythmias, Cardiac
Heart Failure and Sudden Cardiac Death Japan Registry
The purpose of this observational registry is to collect clinical events and outcome data in 4 different study populations (cohorts), with a majority of Japanese subjects, that are at risk of sudden cardiac death (SCD) and heart…
- Conditions
- Heart Failure, Arrhythmias, Cardiac, Sudden Cardiac Death
- Trial name
- HINODE (NCT03185832)
- Testing
- CRT-D, ICD, PM / CRT-P
- Where
- 34 sites in Japan
- Volunteers
- 354 people
- Sponsor
- Boston Scientific Corporation
Sudden Cardiac Death, Bradycardia
REASSURE AV Registry
Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device.
- Trial name
- REASSURE (NCT01074034)
- Testing
- AV Therapy Assessment-B301 investigational device
- Where
- 36 sites in United States
- Volunteers
- 211 people
- Sponsor
- Boston Scientific Corporation
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.