An interventional study of PliCath HF System in Heart Failure, sponsored by BioVentrix. Completed at 19 sites in 11 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-03-11.
Sponsored by BioVentrix · Not applicable, Interventional, and Treatment
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 appropriate cohorts of humans suffering from heart failure.
Congestive heart failure is the "epidemic" of cardiovascular disease (Eugene Braunwald, NEJM 1997), yet there is no cure. The American Heart Association reports the nearly five million Americans are afflicted. Approximately 1.5 million admissions in the US are due to heart failure; it is the number one cost-item for Medicare, comprising 6% of its total expenditures.
BioVentrix has developed the PliCath heart failure system, which is used to place permanent cardiac implants into the heart for the purpose of excluding scar, reconfiguring abnormal cardiac geometry that is causing dysfunction, by excluding an abnormal portion of the ventricular wall. Conceptually, the final configuration in SVR can be achieved by placing these implants.
The procedure called PliCath Epicardial Catheter-based Ventricular Restoration System (ECVR) is designed for left ventricular volume reduction in patients with heart failure in a magnitude similar to that of the predicate surgical procedure, but much less invasively. The PliCath HF System utilizes anchors that are implanted into the scarred portion of the heart, which when deployed, exclude some of the scar similar to what is excluded by cinching the purse string suture with the patch, rendering the ventricle smaller, and is employed in a surgical setting, with and without the use of cardiopulmonary bypass.
The PliCath HF System has anchors (implants) that are deployed using fluoroscopic imaging.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 120 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →BioVentrix is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Treatment with the investigational device.
Device: PliCath HF System
This study is a multi-center, prospective, single-armed, study designed to evaluate the safety and efficacy of the BioVentrix PliCath HF System for left ventricular volume restoration in patients with ischemic cardiomyopathy.
Also known as: Epicardial Catheter-based Ventricular Restoration, Dor, Surgical/Left Ventricular Reconstruction
Primary Safety Endpoint - Overall rate of serious adverse events.
An assessment of the overall rate of serious adverse events (SAEs) at 1 year and 2 years as adjudicated by the Data Monitoring Committee (DMC).
Time frame: 24 Months
Primary Efficacy Endpoint - Reduction in LV Volume
An assessment of measurable decrease in LV volume by either an echo or a CMR at 6 months, 1 year and 2 years.
Time frame: 24 Months
Secondary Safety Endpoint: Assessment of overall rate of serious adverse device effects.
The secondary safety endpoint will be an assessment of the overall rate of serious adverse device effects (SADEs) through 2 years as adjudicated by the DMC.
Time frame: 24 Months post operatively
Secondary Efficacy Endpoint: • Change in Left Ventricular Ejection Fraction
Change in Left Ventricular Ejection Fraction (LVEF)as measured by ECHO or MRI.
Time frame: 24 Months
Secondary Efficacy Endpoint: Hospital readmission for HF
Hospital readmission for HF including surgical intervention such as Ventricular Assist Device, Cardiac Resynchronization Therapy, Intra-Aortic Balloon Pump, or transplant;
Time frame: 24 Months
Secondary Efficacy Endpoint: Clinical utility
Change in NYHA Class, Change in a standardized 6-minute corridor walk test; Change in Quality of Life (QOL) by Minnesota Living with Heart Failure (MLHF) Questionnaire.
Time frame: 24 Months
Secondary Efficacy Endpoint: NT-proBNP
Change in NT-proBNP levels
Time frame: 24 Months
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
BioVentrix