Safety and Efficacy Study of the BioVentrix PliCath HF System (CONFIGURE-HF)
|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:||April 2018|
|Estimated Primary Completion Date:||April 2018 (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568164
|Medical University Innsbruck|
|Innsbruck, Austria, 602|
|NA Holmoce Hospital|
|Prague, Czech Republic, 1503|
|Bordeaux University Hospital Cardiology|
|Bordeaux, France, 33604|
|Hospital Pitie Sal Petirere Institute of Cardiology|
|Paris, France, 75013|
|Onassis Cardiac Surgery Center|
|Athens, Greece, 17674|
|Spedali Civili di Cardiochirurgia|
|Brescia, Italy, 1 25123|
|IRCCS Istituto Policlinico San Donato|
|Milan, Italy, 20097|
|Ospedale San Raffaele|
|Milan, Italy, 20132|
|Padova University Hospital|
|Padova, Italy, I-35128|
|Azienda Ospedaliera S.Camillo-Forlanini|
|Rome, Italy, 87|
|Ospedale Le Molinetto|
|Torino, Italy, 10126|
|Pauls Stradins Clinical University|
|Vilnius Hospital Santariskiu Klinikus|
|Vilnius, Lithuania, 08661|
|Polish American Hospital|
|Katowice, Poland, 40-534|
|Krakow, Poland, 31-202|
|CHVNGaia / Espinho Hospital|
|Porto, Portugal, 4434-502|
|Hospital Clinic and University of Barcelona|
|Kings College Hospital|
|London, United Kingdom, SE594S|
|The Royal Brompton Hospital|
|London, United Kingdom, SW36NP|
|Study Director:||Lon Annest, MD||Chief Medical Officer, BioVentrix|