Clinical trials: Sudden Cardiac Death
Sudden Cardiac Arrest
The Intrepid Clinical Engineering Study
The purpose of this research study is to collect clinical data to validate a software update for 12-lead electrocardiogram monitoring.
- Trial name
- NCT05636332
- Testing
- 12 lead Electrocardiogram
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Heartstream US LLC
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
Cardiovascular Diseases, Cardiovascular Diseases Risk
Cor360: Clinician-Facing Broad-Spectrum Cardiac Phenotyping and Risk Assessment Using COR® Wearable ECG to Inform Outcomes-Oriented Care Pathways
Cor360 is an observational study evaluating whether extended wearable electrocardiogram (ECG) data can support broad-spectrum cardiac phenotyping and risk assessment beyond conventional single-purpose ambulatory rhythm…
- Conditions
- Cardiovascular Diseases, Cardiovascular Diseases Risk, Cardiac Conduction System Disease, Bundle/Fascicular Abnormalities
- Trial name
- Cor360 (NCT07775976)
- Testing
- COR Wearable ECG Monitoring, Cor360 Clinician-Facing Decision-Aid Reporting
- Where
- 2 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
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
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
Cardiomyopathies, Cardiac Arrest
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
WILLEM is a multi-center, prospective and retrospective cohort study. The study will assess the performance of a cloud-based and AI-powered ECG analysis platform, named Willem™, developed to detect arrhythmias and other abnormal…
- Conditions
- Cardiomyopathies, Cardiac Arrest, Cardiac Arrhythmias, Sudden Cardiac Death
- Trial name
- WILLEM (NCT05890716)
- Testing
- AI-powered ECG analysis to detect cardiac arrhythmic episodes
- Where
- 13 sites in Netherlands, Spain
- Volunteers
- 5,342 people, healthy volunteers welcome
- Sponsor
- Idoven 1903 S.L.
Heart Failure, Heart Failure With Reduced Ejection Fraction
Assessment of Combined CCM and ICD Device in HFrEF
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or…
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Implantable Defibrillator User, CCM Therapy
- Trial name
- INTEGRA-D (NCT05855135)
- Testing
- OPTIMIZER® Integra CCM-D System (Treatment Arm)
- Where
- 59 sites in United States
- Volunteers
- 300 people
- Sponsor
- Impulse Dynamics
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.
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.
PKP2 Arrhythmogenic Cardiomyopathy (PKP2-ACM)
A Phase 1, Dose Escalation Trial of RP-A601 in Subjects With PKP2 Variant-Mediated Arrhythmogenic Cardiomyopathy (PKP2-ACM)
This Phase 1 dose escalation trial will assess the safety and preliminary efficacy of a single dose intravenous infusion of RP-A601 in high-risk adult patients with PKP2-ACM.
- Trial name
- NCT05885412
- Testing
- RP-A601
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- Rocket Pharmaceuticals Inc.
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
Arrhythmogenic Cardiomyopathy, PKP2-ACM
Long-term Follow-up Study of Gene Therapy for Arrhythmogenic Cardiomyopathy Due to a Plakophilin-2 Pathogenic Variant
The primary objective of this Phase 1/2 long-term follow-up (LTFU) study is to assess the long-term safety and tolerability of LX2020 for the treatment of arrhythmogenic cardiomyopathy (ACM) due to a plakophilin-2 gene (PKP2)…
- Conditions
- Arrhythmogenic Cardiomyopathy, PKP2-ACM, PKP2-ARVC
- Trial name
- GRIT-PKP2 (NCT07050160)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Lexeo Therapeutics
Sudden Cardiac Arrest
ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)
Active surveillance study using real-world data collected in the ASSURE Patient Registry. Outcome measures are based on analysis of ASSURE Registry data including data recorded by the WCD then annotated by clinical experts in…
- Trial name
- ACE-PAS (NCT05135403)
- Testing
- Defibrillation
- Where
- United States
- Volunteers
- 5,179 people
- Sponsor
- Kestra Medical Technologies, Inc.
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
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