Prospective Study of the BioVentrix PliCath HF™ System for the Treatment of Ischemic Cardiomyopathy
Condition: Heart Failure
MeSH terms: Cardiomyopathies
Study type: Interventional

Summary: 
      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).
    

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.
    

Intervention name(s): PliCath HF System
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): Epicardial Catheter-based Ventricular Restoration; Left or Surgical Ventricular Reconstruction; Dor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ventricular Remodeling