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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01568164
First Posted: April 2, 2012
Last Update Posted: October 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ohio State University
CDI Centro Diagnostico Italiano
Advance Research Associates
Information provided by (Responsible Party):
BioVentrix
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
    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 ]
    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 ]
    Change in Left Ventricular Ejection Fraction (LVEF)as measured by ECHO or MRI.

  • Secondary Efficacy Endpoint: Hospital readmission for HF [ Time Frame: 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: Clinical utility [ Time Frame: 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: NT-proBNP [ Time Frame: 24 Months ]
    Change in NT-proBNP levels


Estimated Enrollment: 120
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)
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:
  • 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568164


Locations
Austria
Medical University Innsbruck
Innsbruck, Austria, 602
Czech Republic
NA Holmoce Hospital
Prague, Czech Republic, 1503
France
Bordeaux University Hospital Cardiology
Bordeaux, France, 33604
Hospital Pitie Sal Petirere Institute of Cardiology
Paris, France, 75013
Greece
Onassis Cardiac Surgery Center
Athens, Greece, 17674
Italy
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
Latvia
Pauls Stradins Clinical University
Riga, Latvia
Lithuania
Vilnius Hospital Santariskiu Klinikus
Vilnius, Lithuania, 08661
Poland
Polish American Hospital
Katowice, Poland, 40-534
Jagiellonian University
Krakow, Poland, 31-202
Portugal
CHVNGaia / Espinho Hospital
Porto, Portugal, 4434-502
Spain
Hospital Clinic and University of Barcelona
Barcelona, Spain
United Kingdom
Kings College Hospital
London, United Kingdom, SE594S
The Royal Brompton Hospital
London, United Kingdom, SW36NP
Sponsors and Collaborators
BioVentrix
Ohio State University
CDI Centro Diagnostico Italiano
Advance 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
First Submitted: March 29, 2012
First Posted: April 2, 2012
Last Update Posted: October 4, 2016
Last Verified: September 2016

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