Safety and Efficacy Study of the BioVentrix PliCath HF System
- Conditions
- Heart Failure
- Interventions
- Device: PliCath HF System
- Registration Number
- NCT01568164
- Lead Sponsor
- BioVentrix
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Device Treatment PliCath HF System Treatment with the investigational device.
- Primary Outcome Measures
Name Time Method Primary Safety Endpoint - Overall rate of serious adverse events. 24 Months 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).
Primary Efficacy Endpoint - Reduction in LV Volume 24 Months An assessment of measurable decrease in LV volume by either an echo or a CMR at 6 months, 1 year and 2 years.
- Secondary Outcome Measures
Name Time Method Secondary Safety Endpoint: Assessment of overall rate of serious adverse device effects. 24 Months post operatively 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.
Secondary Efficacy Endpoint: Clinical utility 24 Months 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.
Secondary Efficacy Endpoint: Hospital readmission for HF 24 Months Hospital readmission for HF including surgical intervention such as Ventricular Assist Device, Cardiac Resynchronization Therapy, Intra-Aortic Balloon Pump, or transplant;
Secondary Efficacy Endpoint: • Change in Left Ventricular Ejection Fraction 24 Months Change in Left Ventricular Ejection Fraction (LVEF)as measured by ECHO or MRI.
Secondary Efficacy Endpoint: NT-proBNP 24 Months Change in NT-proBNP levels
Trial Locations
- Locations (19)
Vilnius Hospital Santariskiu Klinikus
🇱🇹Vilnius, Lithuania
Hospital Pitie Sal Petirere Institute of Cardiology
🇫🇷Paris, France
Spedali Civili di Cardiochirurgia
🇮🇹Brescia, Italy
Azienda Ospedaliera S.Camillo-Forlanini
🇮🇹Rome, Italy
Kings College Hospital
🇬🇧London, United Kingdom
Jagiellonian University
🇵🇱Krakow, Poland
Ospedale Le Molinetto
🇮🇹Torino, Italy
Bordeaux University Hospital Cardiology
🇫🇷Bordeaux, France
The Royal Brompton Hospital
🇬🇧London, United Kingdom
NA Holmoce Hospital
🇨🇿Prague, Czechia
Ospedale San Raffaele
🇮🇹Milan, Italy
Onassis Cardiac Surgery Center
🇬🇷Athens, Greece
Padova University Hospital
🇮🇹Padova, Italy
IRCCS Istituto Policlinico San Donato
🇮🇹Milan, Italy
Pauls Stradins Clinical University
🇱🇻Riga, Latvia
Hospital Clinic and University of Barcelona
🇪🇸Barcelona, Spain
Polish American Hospital
🇵🇱Katowice, Poland
CHVNGaia / Espinho Hospital
🇵🇹Porto, Portugal
Medical University Innsbruck
🇦🇹Innsbruck, Austria