Clinical trial NCT01568164: Safety and Efficacy Study of the BioVentrix PliCath HF System
Official title: Phase II Study of the BioVentrix PliCath HF™ System for the Treatment of Ischemic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Epicardial Catheter-based Restoration
Surgical/Left Ventricular Reconstruction
Ventricular Remodeling
Dor
Lead sponsor: BioVentrix
Sponsor class: INDUSTRY
Collaborators: name: Ohio State University
name: CDI Centro Diagnostico Italiano
name: Advance Research Associates
First posted: 2012-04-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Primary Safety Endpoint - Overall rate of serious adverse events.
timeFrame: 24 Months
measure: Primary Efficacy Endpoint - Reduction in LV Volume
timeFrame: 24 Months
Secondary outcomes:
measure: Secondary Safety Endpoint: Assessment of overall rate of serious adverse device effects.
timeFrame: 24 Months post operatively
measure: Secondary Efficacy Endpoint: • Change in Left Ventricular Ejection Fraction
timeFrame: 24 Months
measure: Secondary Efficacy Endpoint: Hospital readmission for HF
timeFrame: 24 Months
measure: Secondary Efficacy Endpoint: Clinical utility
timeFrame: 24 Months
measure: Secondary Efficacy Endpoint: NT-proBNP
timeFrame: 24 Months
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University Innsbruck
city: Prague
country: Czechia
facility: NA Holmoce Hospital
city: Bordeaux
country: France
facility: Bordeaux University Hospital Cardiology
city: Paris
country: France
facility: Hospital Pitie Sal Petirere Institute of Cardiology
city: Athens
country: Greece
facility: Onassis Cardiac Surgery Center
city: Brescia
country: Italy
facility: Spedali Civili di Cardiochirurgia
city: Milan
country: Italy
facility: IRCCS Istituto Policlinico San Donato
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Padova
country: Italy
facility: Padova University Hospital
city: Rome
country: Italy
facility: Azienda Ospedaliera S.Camillo-Forlanini
city: Torino
country: Italy
facility: Ospedale Le Molinetto
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University
city: Vilnius
country: Lithuania
facility: Vilnius Hospital Santariskiu Klinikus
city: Katowice
country: Poland
facility: Polish American Hospital
city: Krakow
country: Poland
facility: Jagiellonian University
city: Porto
country: Portugal
facility: CHVNGaia / Espinho Hospital
city: Barcelona
country: Spain
facility: Hospital Clinic and University of Barcelona
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: The Royal Brompton Hospital
Study officials:
affiliation: Chief Medical Officer, BioVentrix
name: Lon Annest, MD
role: STUDY_DIRECTOR
References:
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.