Clinical trials: Left Ventricular 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
Left Ventricle Remodeling, Left Ventricle Dilated
RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial
A prospective, multi-center randomized trial comparing the Revivent System plus GDMT to GDMT alone. A total of approximately 135 subjects will be randomized in a 2:1 allocation ratio (90 treatment and 45 control), with…
- Conditions
- Left Ventricle Remodeling, Left Ventricle Dilated, CHF
- Trial name
- RELIVE (NCT06813820)
- Testing
- Revivent System
- Where
- 6 sites in United States
- Volunteers
- 135 people
- Sponsor
- BioVentrix
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
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.