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

March 10, 2021 updated by: BioVentrix

Phase II Study of the BioVentrix PliCath HF™ System for the Treatment of Ischemic Cardiomyopathy

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 602
        • Medical University Innsbruck
  • Czechia
      • Prague, Czechia, 1503
        • NA Holmoce Hospital
  • France
      • Bordeaux, France, 33604
        • Bordeaux University Hospital Cardiology
      • Paris, France, 75013
        • Hospital Pitie Sal Petirere Institute of Cardiology
  • Greece
      • Athens, Greece, 17674
        • Onassis Cardiac Surgery Center
  • Italy
      • Brescia, Italy, 1 25123
        • Spedali Civili di Cardiochirurgia
      • Milan, Italy, 20132
        • Ospedale San Raffaele
      • Milan, Italy, 20097
        • IRCCS Istituto Policlinico San Donato
      • Padova, Italy, I-35128
        • Padova University Hospital
      • Rome, Italy, 87
        • Azienda Ospedaliera S.Camillo-Forlanini
      • Torino, Italy, 10126
        • Ospedale Le Molinetto
  • Latvia
      • Riga, Latvia
        • Pauls Stradins Clinical University
  • Lithuania
      • Vilnius, Lithuania, 08661
        • Vilnius Hospital Santariskiu Klinikus
  • Poland
      • Katowice, Poland, 40-534
        • Polish American Hospital
      • Krakow, Poland, 31-202
        • Jagiellonian University
  • Portugal
      • Porto, Portugal, 4434-502
        • CHVNGaia / Espinho Hospital
  • Spain
      • Barcelona, Spain
        • Hospital Clinic and University of Barcelona
  • United Kingdom
      • London, United Kingdom, SE594S
        • Kings College Hospital
      • London, United Kingdom, SW36NP
        • The Royal Brompton Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
24 Months
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.
24 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 Months post operatively
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.
24 Months
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;
24 Months
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.
24 Months
Secondary Efficacy Endpoint: NT-proBNP
Time Frame: 24 Months
Change in NT-proBNP levels
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioVentrix

Collaborators

Ohio State University
CDI Centro Diagnostico Italiano
Advance Research Associates

Investigators

  • Study Director: Lon Annest, MD, Chief Medical Officer, BioVentrix

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

March 29, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (Estimate)

April 2, 2012

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 10, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-0015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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