Clinical trials: Cardiac Remodeling
Ventricular Ejection Fraction, LVF
AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor
This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF)…
- Conditions
- Ventricular Ejection Fraction, LVF, LV Dysfunction, Atrial Enlargement
- Trial name
- EFACT (NCT06699056)
- Testing
- 15-minutes of sitting during COR ECG Acquistion
- Where
- 8 sites in United States
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Peerbridge Health, Inc
Heart Failure, Left Ventricle Remodeling
ALIVE Expended Access - Clinical Study
A prospective, multi-center, single-arm study. This study will enroll a maximum of 35 subjects treated with the Revivent TC System.
- Trial name
- ALIVE-EA (NCT05710042)
- Testing
- Revivent TC System
- Where
- 2 sites in United States
- Sponsor
- BioVentrix
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
Acute Myocardial Infarction, Congestive Heart Failure
IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction
The primary objective is to evaluate the safety and effectiveness of the IK-5001 device for the prevention of ventricular remodeling and congestive heart failure when administered to subjects who had successful percutaneous…
- Conditions
- Acute Myocardial Infarction, Congestive Heart Failure, ST-Elevation Myocardial Infarction
- Trial name
- PRESERVATION-1 (NCT01226563)
- Testing
- IK-5001, Saline Solution
- Where
- 82 sites in United States, Australia and 7 more
- Volunteers
- 303 people
- Sponsor
- Bellerophon BCM LLC
Heart Failure
Prospective Study of the BioVentrix PliCath HF™ System for the Treatment of Ischemic Cardiomyopathy
The purpose of the study is to determine the safety, and feasibility of a device, which enables LV volume and radius reduction through scar exclusion in patients whose systolic HF is due to ischemic cardiomyopathy.
- Trial name
- CONFIGURE-HF (NCT01568138)
- Testing
- PliCath HF System
- Where
- 4 sites in Latvia, Lithuania and 2 more
- Volunteers
- 26 people
- Sponsor
- BioVentrix
Heart Failure
Safety and Efficacy Study of the BioVentrix PliCath HF System
The purpose of this prospective, single-armed, multi-center clinical trial is to further establish the safety and feasibility of using the BioVentrix PliCath HF System for the treatment of left ventricular dysfunction in…
- Trial name
- CONFIGURE-HF (NCT01568164)
- Testing
- PliCath HF System
- Where
- 19 sites in Austria, Czechia and 9 more
- Volunteers
- 120 people
- Sponsor
- BioVentrix
Myocardial Infarction, Heart Failure
A Study of VentriGel in Post-MI Patients
This Phase I, open label, study will investigate the effects of VentriGel injection in patients who have experienced a first, large ST elevation myocardial infarction (STEMI) treated by PCI within the past 3 years and have…
- Conditions
- Myocardial Infarction, Heart Failure, Left Ventricular Remodeling
- Trial name
- NCT02305602
- Testing
- VentriGel
- Where
- 6 sites in United States
- Volunteers
- 15 people
- Sponsor
- Ventrix, Inc.
Acute Myocardial Infarction, Pacing Therapy
Post-Myocardial Infarction Remodeling Prevention Therapy
The purpose of this study is to demonstrate the feasibility of pacing as a therapy to prevent adverse remodeling of the myocardium following an acute myocardial infarction (MI) in patients at highest risk for adverse myocardial…
- Conditions
- Acute Myocardial Infarction, Pacing Therapy, Cardiac Remodeling, Heart Failure
- Trial name
- PRomPT (NCT01213251)
- Testing
- Single Site Pacing, Dual Site Pacing
- Where
- 26 sites in United States, Denmark and 5 more
- Volunteers
- 129 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure