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Prospective Study of the BioVentrix PliCath HF™ System for the Treatment of Ischemic Cardiomyopathy (CONFIGURE-HF)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by BioVentrix.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Ohio State University
Centro Diagnostico Italiano
Advanced Research Associates
Information provided by (Responsible Party):
BioVentrix
ClinicalTrials.gov Identifier:
NCT01568138
First received: March 29, 2012
Last updated: April 2, 2012
Last verified: April 2012
  Purpose

The purpose of the study is to determine the safety, and feasibility of a device, which enables LV volume and radius reduction through scar exclusion in patients whose systolic HF is due to ischemic cardiomyopathy.

Appropriate subjects will have akinetic or dyskinetic scar located in the antero-septal LV distribution. Use of this device replicates the geometric reconfiguration of the ventricle achieved through surgical Left Ventricular Reconstruction (LVR), but on a beating, unsupported heart, thereby creating the option of avoiding the use of cardiopulmonary bypass pump (CBP).


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: This Study is a Multi-center, Prospective, Single-armed, Study Designed to Evaluate the Safety and Feasibility of the BioVentrix PliCath HF System for Left Ventricular (LV) Volume and Radius Reduction Through Scar Exclusion in Patients Whose Systolic HF is Due to Ischemic Cardiomyopathy.

Resource links provided by NLM:


Further study details as provided by BioVentrix:

Primary Outcome Measures:
  • Assessment of overall rate of serious adverse device effects [ Time Frame: 12 Months Post-operative ] [ Designated as safety issue: Yes ]
    The primary safety endpoint is an assessment of the overall rate of serious adverse device effects through 12 months as adjudicated by the Data Monitoring Committee.


Secondary Outcome Measures:
  • Assessment of overall rate of serious adverse events [ Time Frame: 12 Months post-operative ] [ Designated as safety issue: Yes ]
    The secondary safety endpoint is an assessment of the overall rate of serious adverse events through 12 months as adjudicated by the Data Monitoring Committee.


Enrollment: 26
Study Start Date: August 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: PliCath HF System
    To evaluate the safety and feasibility of the BioVentrix PliCath HF Epicardial Catheter-based Ventricular Reduction (ECVR) System for left ventricular (LV) volume reduction in heart failure (HF). The System utilizes anchors that are implanted into the scarred portion of the heart, rendering the ventricle smaller.
    Other Names:
    • PliCath HF System
    • Epicardial Catheter-based Ventricular Restoration
    • Left or Surgical Ventricular Reconstruction
    • Dor
Detailed Description:

Congestive heart failure is the "epidemic" of cardiovascular disease (Eugene Braunwald, NEJM 1997), yet there is no cure. The American Heart Association (AHA) reports the nearly five million Americans are afflicted. Approximately 1.5 million admissions in the US are due to heart failure (HF); it is the number one cost-item for Medicare, comprising 6% of its total expenditures.

In view of the limitations of existing therapy, physicians have sought alternative treatments. In this regard, there has been longstanding interest in surgical reconstruction of the failing heart. The underlying premise has been to surgically reduce the size of the ventricular chamber by removing a portion of the ventricular wall to decrease chamber radius. A reduction of chamber radius reduces wall stress for a given pressure so that the remaining muscle is put into a more favorable mechanical state.

The BioVentrix PliCath HF System consists of implantable anchors, the delivery system, and accessories, which are sterile and biocompatible. These devices are used in the reconfiguration of the abnormal cardiac geometry that is causing dysfunction by excluding a portion of the left ventricular chamber.

The procedure is based on the premise that the beneficial effects of Left Ventricular Reconstruction (LVR) via radius and volume reduction, can be realized by excluding a portion of the scarred left ventricle wall circumference. The procedure is similar to a Dor procedure except that it utilizes a series of anchors in place of the Fontan stitch and patch to exclude infarcted tissue and reduce the size of the left ventricle chamber and the scarred left ventricle wall. Because the ventricle is not resected, it is possible to do the procedure without a cardiopulmonary bypass pump.

The validity of this concept has been documented. Geometric confirmation was initially accomplished in a bench model, where radius was decreased by 24% and volume was diminished by 35% after exclusion of an antero-septal wall segment in dilated, explanted porcine hearts.

When using the PliCath System in accomplishing LV reconfiguration, the fundamental technical maneuver is placement of a hollow needle through a predetermined site in the anterior wall scar, across the LV chamber, and through a predetermined site in the scarred interventricular septum. Once achieved, a flexible guidewire is advanced through the needle and into the free right ventricular (RV) chamber. Once the wire is completely through the septum, a dilator enables passage of a 14Fr Introducer to traverse the needle route, allowing introduction of an internal, elongated anchor which can be oriented into appropriate alignment and matched with an external anchor of identical length and alignment. The anchors, which are placed in the RV and on the epicardium as a result of the original needle passage, can be brought toward each other until contact between the two walls is established and they are apposed along their lengths. The action is repeated (i.e., repeated needle sticks and anchor placement), along the long axis of the LV until a linear portion of antero-lateral wall is in contact with a corresponding portion of the septum, excluding the entire intervening wall segment from the circumference of the chamber.

The device is designed to allow removal at any stage of deployment prior to removal of the "Leash" attached to the hinged, internal anchor.

  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
  • 15% ≥ LVEF ≤ 45%
  • NYHA FC II-III
  • 60 cc/m² ≥ LVESV/I ≤ 120 cc/m²
  • Acontractile (akinetic and/or dyskinetic) scar located in the antero-septalapical region due to prior infarction as evidenced by an echocardiogram and/or an MRI
  • 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 an echocardiogram and/or an MRI
  • Agree to required follow-up visits

Exclusion Criteria:

  • Calcified ventricular wall in the akinetic region
  • Thrombus or intra-ventricular mass in left atrium or ventricle Cardiac Resynchronization Therapy (CRT) device placement within prior 60 days of enrollment
  • Significant diastolic dysfunction, defined as a pseudonormal 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 an MRI
  • Cardiac valve disease which, in the opinion of the investigator, will require surgery
  • Mitral Regurgitation > 1+
  • Intolerance or unwillingness to take warfarin
  • 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
  • Myocardial Infarction within prior 90 days enrollment
  • Previous CVA or TIA which resulted, in the opinion of the investigator, in a significant residual neurological deficit
  • 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: NCT01568138

Locations
Latvia
Pauls Stradins Hospital
Riga, Latvia
Lithuania
Santariskiu Klinikus
Vilnius, Lithuania
Poland
Jagiellonian University Hospital
Krakow, Poland
Russian Federation
Bakoulev Institute
Moscow, Russian Federation
Sponsors and Collaborators
BioVentrix
Ohio State University
Centro Diagnostico Italiano
Advanced Research Associates
  More Information

Additional Information:
No publications provided

Responsible Party: BioVentrix
ClinicalTrials.gov Identifier: NCT01568138     History of Changes
Other Study ID Numbers: 20032-P
Study First Received: March 29, 2012
Last Updated: April 2, 2012
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Lithuania: Vilnius Regional Ethics Committee for Biomedical Studies and State Health Care Accreditation Agency under the Ministry of Health
Latvia: Ethics Committee for Clinical Research at Pauls Stradins Clinical University Hospital Development Society and State Agency of Medicines
Russia: Ethics Committee
Austria: Ethics Committee of the Medical University of Innsbruck and BASG/AGES PharmMed Inspections, Medical Devices and Hemovigilance Institute

Keywords provided by BioVentrix:
Ventricular Remodeling

Additional relevant MeSH terms:
Cardiomyopathies
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014