Clinical trials: Ventricular Remodeling
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
Heart Failure
Safety Study of the Ventricular Partitioning Device (VPD) Implant System in Heart Failure Patients
The CardioKinetix Ventricular Partitioning Device (VPD) is intended to isolate the malfunctioning portion of the left ventricle in patients with symptoms of heart failure due to ischemic heart disease.
- Trial name
- PARACHUTE (NCT00573560)
- Testing
- VPD Implant System
- Where
- 7 sites in United States, Serbia
- Volunteers
- 20 people
- Sponsor
- CardioKinetix, 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
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
Safety and Efficacy of Aliskiren in Post Myocardial Infarction Patients (ASPIRE)
The core and extension studies assessed the safety and efficacy of aliskiren when added to optimized standard therapy in patients that have had a high risk acute myocardial infarction (heart attack).
- Trial name
- NCT00414609
- Testing
- Aliskiren
- Where
- 23 sites in United States, Argentina and 21 more
- Volunteers
- 820 people
- Sponsor
- Novartis
Heart Failure, Myocardial Infarction
A Multinational Trial To Evaluate The Parachute Implant System
The primary objective is to assess the safety of the CardioKinetix Parachute Implant and Delivery System in the partitioning of the left ventricle in patients with heart failure due to ischemic heart disease.
- Trial name
- PARACHUTE (NCT01286116)
- Testing
- Parachute Implant
- Where
- 13 sites in France, Germany and 6 more
- Volunteers
- 59 people
- Sponsor
- CardioKinetix, Inc
Heart Failure
REmodeling the Left Ventricle With Atrial Modulated Pacing
New therapy tested in heart failure with preserved ejection fraction (HFpEF) patients with approved indications for pacing to determine if elevated pacing therapy is tolerated and whether there is a signal for efficacy.
- Trial name
- REVAMP (NCT03210402)
- Testing
- Elevated night pacing on, Elevated night pacing off
- Where
- 10 sites in United States
- Volunteers
- 22 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Congestive
The Purpose of This Study is to Determine if Eplerenone is Effective in Treatment of Mild to Moderate Heart Failure
The purpose of this study is to determine if eplerenone is effective in the treatment of mild to moderate heart failure
- Trial name
- REMODEL (NCT00082589)
- Testing
- Eplerenone
- Where
- 53 sites in United States
- Volunteers
- 250 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris 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
Pulmonary Arterial Hypertension
A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Participants With Pulmonary Arterial Hypertension
The primary objective of this study is to assess the effect of early and rapid treprostinil therapy for mean pulmonary artery pressure (mPAP) reduction to improve right ventricular (RV) function and reverse RV remodeling in…
- Trial name
- ARTISAN (NCT05203510)
- Testing
- Parenteral Treprostinil, Oral Treprostinil
- Where
- 28 sites in United States
- Volunteers
- 52 people
- Sponsor
- United Therapeutics
Heart Failure, Congestive
Rosuvastatin Impact on Ventricular Remodelling Lipids and Cytokines
The purpose of this study is to assess the effect of rosuvastatin (up-titrated to a dose of 40mg/day) compared to placebo on cardiac remodelling, estimated by change in left ventricular ejection fraction on radionuclide…
- Trial name
- NCT00240292
- Testing
- Rosuvastatin
- Where
- 13 sites in Australia
- Volunteers
- 160 people
- Sponsor
- AstraZeneca
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, Congestive
Reversal of Ventricular Remodeling With Toprol-XL
The purpose of this study is to determine whether treatment with Toprol-XL for 12 months in asymptomatic heart failure subjects will improve their heart structure and thus prevent the progression to symptomatic disease.
- Trial name
- NCT00038077
- Testing
- Seloken ZOK/Toprol-XL
- Where
- 44 sites in United States
- Volunteers
- 300 people
- Sponsor
- AstraZeneca
Heart Failure
Effects of Sacubitril/Valsartan Therapy on Biomarkers, Myocardial Remodeling and Outcomes.
This study was to determine early and more chronic changes in concentrations of biomarkers related to mechanisms of action (MOA) and effects of sacubitril/valsartan therapy over a period of 12 months, and correlated these…
- Trial name
- PROVE-HF (NCT02887183)
- Testing
- LCZ696 (sacubitril/valsartan)
- Where
- 77 sites in United States
- Volunteers
- 794 people
- Sponsor
- Novartis Pharmaceuticals
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, Non-ST Elevation Myocardial Infarction
Impact of Cardiac Rehabilitation Programs on Left Ventricular Remodeling After Acute Myocardial Infarction - the REHAB Trial
The aim of REHAB trial is to investigate the impact of early mobilization after AMI in reducing left ventricular remodeling, as assessed by cardiac magnetic resonance imaging.
- Conditions
- Acute Myocardial Infarction, Non-ST Elevation Myocardial Infarction, Systemic Inflammation, Ventricular Remodeling
- Trial name
- NCT04161378
- Testing
- Cardiac imaging, Laboratory analysis
- Where
- Romania
- Volunteers
- 100 people
- Sponsor
- Cardio Med Medical Center
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
The Product Surveillance Registry REVERSE Post Approval Study
The purpose of the REVERSE Post Approval Study (PAS) is to confirm the benefit observed in the REVERSE and RAFT pivotal studies in "real-world" clinical practice.
- Trial name
- PSR-REVERSE (NCT01660035)
- Where
- 123 sites in United States, Belgium and 8 more
- Volunteers
- 155 people
- Sponsor
- Medtronic
Acute Myocardial Infarction, Heart Failure
Inflammation-mediated Coronary Plaque Vulnerability, Myocardial Viability and Ventricular Remodeling
VIABILITY study aims to investigate the link between systemic inflammation, pancoronary plaque vulnerability (referring to the plaque vulnerability within the entire coronary tree), myocardial viability and ventricular remodeling…
- Trial name
- VIABILITY (NCT03830944)
- Testing
- Blood sampling, transthoracic echocardiography, Late Gadolinium-Enhancement Cardiac Magnetic Resonance
- Where
- Romania
- Volunteers
- 150 people
- Sponsor
- Cardio Med Medical Center
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