Safety and Efficacy Study of the BioVentrix PliCath HF System

NCT ID: NCT01568164

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2019-12-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device Treatment

Treatment with the investigational device.

Group Type: EXPERIMENTAL

PliCath HF System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Epicardial Catheter-based Ventricular Restoration; Dor; Surgical/Left Ventricular Reconstruction

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: collaborator

CDI Centro Diagnostico Italiano

UNKNOWN

Sponsor Role: collaborator

Advance Research Associates

OTHER

Sponsor Role: collaborator

BioVentrix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lon Annest, MD

Role: STUDY_DIRECTOR

Chief Medical Officer, BioVentrix

Locations

Medical University Innsbruck

Innsbruck, , Austria

NA Holmoce Hospital

Prague, , Czechia

Bordeaux University Hospital Cardiology

Bordeaux, , France

Hospital Pitie Sal Petirere Institute of Cardiology

Paris, , France

Onassis Cardiac Surgery Center

Athens, , Greece

Spedali Civili di Cardiochirurgia

Brescia, , Italy

IRCCS Istituto Policlinico San Donato

Milan, , Italy

Ospedale San Raffaele

Milan, , Italy

Padova University Hospital

Padua, , Italy

Azienda Ospedaliera S.Camillo-Forlanini

Rome, , Italy

Ospedale Le Molinetto

Torino, , Italy

Pauls Stradins Clinical University

Riga, , Latvia

Vilnius Hospital Santariskiu Klinikus

Vilnius, , Lithuania

Polish American Hospital

Katowice, , Poland

Jagiellonian University

Krakow, , Poland

CHVNGaia / Espinho Hospital

Porto, , Portugal

Hospital Clinic and University of Barcelona

Barcelona, , Spain

Kings College Hospital

London, , United Kingdom

The Royal Brompton Hospital

London, , United Kingdom

Countries

Austria; Czechia; France; Greece; Italy; Latvia; Lithuania; Poland; Portugal; Spain; United Kingdom

References

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.

Reference Type: RESULT

PMID: 23739293 (View on PubMed)

Related Links

http://www.bioventrix.com/

Sponsor website

Other Identifiers

CIP-0015

Identifier Type: -

Identifier Source: org_study_id