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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PliCath HF System
Sponsored by
BioVentrix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Epicardial Catheter-based Restoration, Surgical/Left Ventricular Reconstruction, Ventricular Remodeling, Dor

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University Innsbruck
  • NA Holmoce Hospital
  • Bordeaux University Hospital Cardiology
  • Hospital Pitie Sal Petirere Institute of Cardiology
  • Onassis Cardiac Surgery Center
  • Spedali Civili di Cardiochirurgia
  • IRCCS Istituto Policlinico San Donato
  • Ospedale San Raffaele
  • Padova University Hospital
  • Azienda Ospedaliera S.Camillo-Forlanini
  • Ospedale Le Molinetto
  • Pauls Stradins Clinical University
  • Vilnius Hospital Santariskiu Klinikus
  • Polish American Hospital
  • Jagiellonian University
  • CHVNGaia / Espinho Hospital
  • Hospital Clinic and University of Barcelona
  • Kings College Hospital
  • The Royal Brompton Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device Treatment

Arm Description

Treatment with the investigational device.

Outcomes

Primary Outcome Measures

Primary Safety Endpoint - Overall rate of serious adverse events.
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
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.
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
Change in Left Ventricular Ejection Fraction (LVEF)as measured by ECHO or MRI.
Secondary Efficacy Endpoint: Hospital readmission for HF
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
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
Change in NT-proBNP levels

Full Information

First Posted
March 29, 2012
Last Updated
March 10, 2021
Sponsor
BioVentrix
Collaborators
Ohio State University, CDI Centro Diagnostico Italiano, Advance Research Associates
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1. Study Identification

Unique Protocol Identification Number
NCT01568164
Brief Title
Safety and Efficacy Study of the BioVentrix PliCath HF System
Acronym
CONFIGURE-HF
Official Title
Phase II Study of the BioVentrix PliCath HF™ System for the Treatment of Ischemic Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioVentrix
Collaborators
Ohio State University, CDI Centro Diagnostico Italiano, Advance Research Associates

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Epicardial Catheter-based Restoration, Surgical/Left Ventricular Reconstruction, Ventricular Remodeling, Dor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Device Treatment
Arm Type
Experimental
Arm Description
Treatment with the investigational device.
Intervention Type
Device
Intervention Name(s)
PliCath HF System
Other Intervention Name(s)
Epicardial Catheter-based Ventricular Restoration, Dor, Surgical/Left Ventricular Reconstruction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Safety Endpoint - Overall rate of serious adverse events.
Description
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).
Time Frame
24 Months
Title
Primary Efficacy Endpoint - Reduction in LV Volume
Description
An assessment of measurable decrease in LV volume by either an echo or a CMR at 6 months, 1 year and 2 years.
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
Secondary Safety Endpoint: Assessment of overall rate of serious adverse device effects.
Description
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.
Time Frame
24 Months post operatively
Title
Secondary Efficacy Endpoint: • Change in Left Ventricular Ejection Fraction
Description
Change in Left Ventricular Ejection Fraction (LVEF)as measured by ECHO or MRI.
Time Frame
24 Months
Title
Secondary Efficacy Endpoint: Hospital readmission for HF
Description
Hospital readmission for HF including surgical intervention such as Ventricular Assist Device, Cardiac Resynchronization Therapy, Intra-Aortic Balloon Pump, or transplant;
Time Frame
24 Months
Title
Secondary Efficacy Endpoint: Clinical utility
Description
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.
Time Frame
24 Months
Title
Secondary Efficacy Endpoint: NT-proBNP
Description
Change in NT-proBNP levels
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lon Annest, MD
Organizational Affiliation
Chief Medical Officer, BioVentrix
Official's Role
Study Director
Facility Information:
Facility Name
Medical University Innsbruck
City
Innsbruck
ZIP/Postal Code
602
Country
Austria
Facility Name
NA Holmoce Hospital
City
Prague
ZIP/Postal Code
1503
Country
Czechia
Facility Name
Bordeaux University Hospital Cardiology
City
Bordeaux
ZIP/Postal Code
33604
Country
France
Facility Name
Hospital Pitie Sal Petirere Institute of Cardiology
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Onassis Cardiac Surgery Center
City
Athens
ZIP/Postal Code
17674
Country
Greece
Facility Name
Spedali Civili di Cardiochirurgia
City
Brescia
ZIP/Postal Code
1 25123
Country
Italy
Facility Name
IRCCS Istituto Policlinico San Donato
City
Milan
ZIP/Postal Code
20097
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Padova University Hospital
City
Padova
ZIP/Postal Code
I-35128
Country
Italy
Facility Name
Azienda Ospedaliera S.Camillo-Forlanini
City
Rome
ZIP/Postal Code
87
Country
Italy
Facility Name
Ospedale Le Molinetto
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Pauls Stradins Clinical University
City
Riga
Country
Latvia
Facility Name
Vilnius Hospital Santariskiu Klinikus
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Polish American Hospital
City
Katowice
ZIP/Postal Code
40-534
Country
Poland
Facility Name
Jagiellonian University
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
CHVNGaia / Espinho Hospital
City
Porto
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Hospital Clinic and University of Barcelona
City
Barcelona
Country
Spain
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE594S
Country
United Kingdom
Facility Name
The Royal Brompton Hospital
City
London
ZIP/Postal Code
SW36NP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23739293
Citation
Wechsler AS, Sadowski J, Kapelak B, Bartus K, Kalinauskas G, Rucinskas K, Samalavicius R, Annest L. Durability of epicardial ventricular restoration without ventriculotomy. Eur J Cardiothorac Surg. 2013 Sep;44(3):e189-92; discussion e192. doi: 10.1093/ejcts/ezt292. Epub 2013 Jun 5.
Results Reference
result
Links:
URL
http://www.bioventrix.com/
Description
Sponsor website

Learn more about this trial

Safety and Efficacy Study of the BioVentrix PliCath HF System

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