Safety and Efficacy Study of the BioVentrix PliCath HF System (CONFIGURE-HF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by BioVentrix
Sponsor:
Collaborators:
Ohio State University
CDI Centro Diagnostico Italiano
Advanced Research Associates
Information provided by (Responsible Party):
BioVentrix
ClinicalTrials.gov Identifier:
NCT01568164
First received: March 29, 2012
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Heart Failure
Device: PliCath HF System

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by BioVentrix:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Estimated Enrollment: 120
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)
Arms Assigned Interventions
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.
Other Names:
  • PliCath HF System
  • Epicardial Catheter-based Ventricular Restoration
  • Dor
  • Surgical/Left Ventricular Reconstruction

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Age 18 - 80;
  • Left Ventricular Ejection Fraction (LVEF) >15% and ≤ 45%;
  • NYHA FC II-IV;
  • Left Ventricular End Systolic Volume (LVESVI) ≥60 cc/m² but ≤ 120 cc/ m²
  • Contiguous acontractile (akinetic and/or dyskinetic) scar located in the antero-septal, apical (may extend laterally) regions of the left ventricle as evidenced by a CMR or CT;
  • Maintained standard medical management for at least 90 days, and at stable target (or maximum tolerated) dosages;
  • Willing and competent to complete informed consent;
  • Viability of myocardium in regions remote from area of intended scar exclusion as evidenced by CMR or CT;
  • Agree to required follow-up visits

Exclusion Criteria

  • Calcified ventricular wall in the area of intended scar exclusion as verified by echocardiography or equivalent;
  • Thrombus or intra-ventricular mass in the left atrium or ventricle as verified by echocardiography or equivalent;
  • Cardiac Resynchronization Therapy (CRT) device placement ≤ 60 days prior to enrollment;
  • Significant diastolic dysfunction, defined as a pseudo-normal Doppler filling pattern with E/A ratio > 2;
  • Thin walled, paradoxically moving septal scar that would preclude successful support of the anchor pairs as evidenced by CMR;
  • Cardiac valve disease which, in the opinion of the investigator, will require surgery;
  • Intolerance or unwillingness to take anti-coagulation medication;
  • Functioning pacemaker leads in antero-apical RV, which, in the opinion of the investigator, would interfere with anchor placement;
  • Pulmonary Arterial Pressure > 60 mm Hg via echo;
  • Myocardial Infarction within 90 days prior to enrollment;
  • Previous CVA or TIA which resulted, in the opinion of the investigator, in a significant residual neurological deficit;
  • Aorto iliac disease that would preclude fem-fem bypass.
  • Previous right neck surgery, previous pericardiotomy, previous left chest surgery;
  • Co-morbid disease process with life expectancy of less than one year;
  • Patients with lung, kidney and/or liver transplant;
  • Chronic renal failure with a serum creatinine >2 mg/dL;
  • Pregnant or planning to become pregnant during the study;
  • Enrolled in any concurrent study other than observational.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568164

Contacts
Contact: Noel D Messenger +1925-830-1000 ext 201 nmessenger@bioventrix.com
Contact: Wendy R Gries +1925-830-1000 ext 203 wgries@bioventrix.com

Locations
Austria
Medical University Innsbruck Not yet recruiting
Innsbruck, Austria, 602
Contact: Michael Grimm, Prof         
Czech Republic
NA Holmoce Hospital Recruiting
Prague, Czech Republic, 1503
Contact: Stepan Cerny, M.D.         
France
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         
Greece
Onassis Cardiac Surgery Center Not yet recruiting
Athens, Greece, 17674
Contact: George M Palatianos, M.D.         
Italy
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.         
Latvia
Pauls Stradins Clinical University Not yet recruiting
Riga, Latvia
Contact: Peteris Stradins         
Lithuania
Vilnius Hospital Santariskiu Klinikus Recruiting
Vilnius, Lithuania, 08661
Contact: Gintaras Kalinauskas, M.D.         
Poland
Polish American Hospital Not yet recruiting
Katowice, Poland, 40-534
Contact: Marek Cisowksi, M.D., PhD         
Jagiellonian University Recruiting
Krakow, Poland, 31-202
Contact: Jerzy Sadowski, Prof         
Portugal
CHVNGaia / Espinho Hospital Recruiting
Porto, Portugal, 4434-502
Contact: Luis Vouga, MD         
Spain
Hospital Clinic and University of Barcelona Recruiting
Barcelona, Spain
Contact: Jose L Pomar, Prof         
United Kingdom
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         
Sponsors and Collaborators
BioVentrix
Ohio State University
CDI Centro Diagnostico Italiano
Advanced Research Associates
Investigators
Study Director: Lon Annest, MD Chief Medical Officer, BioVentrix
  More Information

Additional Information:
Publications:
Responsible Party: BioVentrix
ClinicalTrials.gov Identifier: NCT01568164     History of Changes
Other Study ID Numbers: CIP-0015
Study First Received: March 29, 2012
Last Updated: November 14, 2013
Health Authority: Austria: Ethics Committee of the Medical University of Innsbruck and BASG/AGES PharmMed Inspections, Medical Device and Hemovigilance Institute
Poland: Bioethics Committee, Beskidzka Chamber of Physicians at Bielsko-Biala and the Office for Registration of Medicinal Products, Medical Devies and Biocides
Lithuania: Vilnius Regional Ethics Committee for Biomedical Studies and State of Health Care Accreditation Agency Under the Ministry of Health
Italy: The Independent Ethics Committee of ASL Milano 2 and the Ministry of Health, Innovation Department, General Department of Drugs and Medical Devices
Czech Republic: Na Homolce Hospital Ethics Committee and SUKL State Institute for Drug Control
Spain: Clinical Research Ethics Committee of the Clinical of the Hospital of Barcelona and AEMPS-Ministry of Health, Social Services and Equality
United Kingdom: National Health Service
Portugal: National Medicine and Health Products Authority; Data Protection Agency
France: Committee for the Protection of Personnes; Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by BioVentrix:
Epicardial Catheter-based Restoration
Surgical/Left Ventricular Reconstruction
Ventricular Remodeling
Dor

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 29, 2014