Safety and Efficacy Study of the BioVentrix PliCath HF System (CONFIGURE-HF)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of the BioVentrix PliCath HF™ System for the Treatment of Ischemic Cardiomyopathy|
- Primary Safety Endpoint - Overall rate of serious adverse events. [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]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 [ Time Frame: 24 Months ] [ Designated as safety issue: No ]An assessment of measurable decrease in LV volume by either an echo or a CMR at 6 months, 1 year and 2 years.
- Secondary Safety Endpoint: Assessment of overall rate of serious adverse device effects. [ Time Frame: 24 Months post operatively ] [ Designated as safety issue: Yes ]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: • Change in Left Ventricular Ejection Fraction [ Time Frame: 24 Months ] [ Designated as safety issue: No ]Change in Left Ventricular Ejection Fraction (LVEF)as measured by ECHO or MRI.
- Secondary Efficacy Endpoint: Hospital readmission for HF [ Time Frame: 24 Months ] [ Designated as safety issue: No ]Hospital readmission for HF including surgical intervention such as Ventricular Assist Device, Cardiac Resynchronization Therapy, Intra-Aortic Balloon Pump, or transplant;
- Secondary Efficacy Endpoint: Clinical utility [ Time Frame: 24 Months ] [ Designated as safety issue: No ]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: NT-proBNP [ Time Frame: 24 Months ] [ Designated as safety issue: No ]Change in NT-proBNP levels
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Device Treatment
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.
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.
|Contact: Noel D Messenger||+1925-830-1000 ext firstname.lastname@example.org|
|Contact: Wendy R Gries||+1925-830-1000 ext email@example.com|
|Medical University Innsbruck||Not yet recruiting|
|Innsbruck, Austria, 602|
|Contact: Michael Grimm, Prof|
|NA Holmoce Hospital||Recruiting|
|Prague, Czech Republic, 1503|
|Contact: Stepan Cerny, M.D.|
|Bordeaux University Hospital Cardiology||Recruiting|
|Bordeaux, France, 33604|
|Contact: Louis Labrousse, MD|
|Hospital Pitie Sal Petirere Institute of Cardiology||Not yet recruiting|
|Paris, France, 75013|
|Contact: Pascal LePrince, MD|
|Onassis Cardiac Surgery Center||Not yet recruiting|
|Athens, Greece, 17674|
|Contact: George M Palatianos, M.D.|
|Spedali Civili di Cardiochirurgia||Recruiting|
|Brescia, Italy, 1 25123|
|Contact: Claudio Muneretto, PhD|
|IRCCS Istituto Policlinico San Donato||Recruiting|
|Milan, Italy, 20097|
|Contact: Lorenzo Menicanti, Prof|
|Ospedale San Raffaele||Not yet recruiting|
|Milan, Italy, 20132|
|Contact: Ottavio Alfieri, Prof|
|Padova University Hospital||Recruiting|
|Padova, Italy, I-35128|
|Contact: Gino Gerosa, M.D.|
|Azienda Ospedaliera S.Camillo-Forlanini||Not yet recruiting|
|Rome, Italy, 87|
|Contact: Francesco Musumeci, M.D.|
|Ospedale Le Molinetto||Recruiting|
|Torino, Italy, 10126|
|Contact: Mauro Rinaldi, M.D.|
|Pauls Stradins Clinical University||Not yet recruiting|
|Contact: Peteris Stradins|
|Vilnius Hospital Santariskiu Klinikus||Recruiting|
|Vilnius, Lithuania, 08661|
|Contact: Gintaras Kalinauskas, M.D.|
|Polish American Hospital||Not yet recruiting|
|Katowice, Poland, 40-534|
|Contact: Marek Cisowksi, M.D., PhD|
|Krakow, Poland, 31-202|
|Contact: Jerzy Sadowski, Prof|
|CHVNGaia / Espinho Hospital||Recruiting|
|Porto, Portugal, 4434-502|
|Contact: Luis Vouga, MD|
|Hospital Clinic and University of Barcelona||Recruiting|
|Contact: Jose L Pomar, Prof|
|The Royal Brompton Hospital||Not yet recruiting|
|London, United Kingdom, SW36NP|
|Contact: Neal Moat, MD|
|Kings College Hospital||Recruiting|
|London, United Kingdom, SE594S|
|Contact: Olaf Wendler, MD|
|Study Director:||Lon Annest, MD||Chief Medical Officer, BioVentrix|