NCT01568164

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable heart-failure

Geographic Reach
11 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2012

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

7.8 years

First QC Date

March 29, 2012

Last Update Submit

March 10, 2021

Conditions

Heart Failure

Keywords

Epicardial Catheter-based RestorationSurgical/Left Ventricular ReconstructionVentricular RemodelingDor

Outcome Measures

Primary Outcomes (2)

  • 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).

    24 Months

  • 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.

    24 Months

Secondary Outcomes (5)

  • Secondary Safety Endpoint: Assessment of overall rate of serious adverse device effects.

    24 Months post operatively

  • Secondary Efficacy Endpoint: • Change in Left Ventricular Ejection Fraction

    24 Months

  • Secondary Efficacy Endpoint: Hospital readmission for HF

    24 Months

  • Secondary Efficacy Endpoint: Clinical utility

    24 Months

  • Secondary Efficacy Endpoint: NT-proBNP

    24 Months

Study Arms (1)

Device Treatment

EXPERIMENTAL

Treatment with the investigational device.

Device: PliCath HF System

Interventions

PliCath HF SystemDEVICE

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.

Also known as: Epicardial Catheter-based Ventricular Restoration, Dor, Surgical/Left Ventricular Reconstruction
Device Treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • Agree to required follow-up visits

You may not qualify if:

  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Medical University Innsbruck

Innsbruck, 602, Austria

Location

NA Holmoce Hospital

Prague, 1503, Czechia

Location

Bordeaux University Hospital Cardiology

Bordeaux, 33604, France

Location

Hospital Pitie Sal Petirere Institute of Cardiology

Paris, 75013, France

Location

Onassis Cardiac Surgery Center

Athens, 17674, Greece

Location

Spedali Civili di Cardiochirurgia

Brescia, 1 25123, Italy

Location

IRCCS Istituto Policlinico San Donato

Milan, 20097, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Padova University Hospital

Padua, I-35128, Italy

Location

Azienda Ospedaliera S.Camillo-Forlanini

Rome, 87, Italy

Location

Ospedale Le Molinetto

Torino, 10126, Italy

Location

Pauls Stradins Clinical University

Riga, Latvia

Location

Vilnius Hospital Santariskiu Klinikus

Vilnius, 08661, Lithuania

Location

Polish American Hospital

Katowice, 40-534, Poland

Location

Jagiellonian University

Krakow, 31-202, Poland

Location

CHVNGaia / Espinho Hospital

Porto, 4434-502, Portugal

Location

Hospital Clinic and University of Barcelona

Barcelona, Spain

Location

Kings College Hospital

London, SE594S, United Kingdom

Location

The Royal Brompton Hospital

London, SW36NP, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 23739293RESULT

Related Links

MeSH Terms

Conditions

Heart FailureVentricular Remodeling

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Lon Annest, MD

    Chief Medical Officer, BioVentrix

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2012

First Posted

April 2, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 11, 2021

Record last verified: 2021-03

Locations

GR(1)ES(1)AU(1)LA(1)CZ(1)PL(2)PT(1)GB(2)IT(6)LI(1)FR(2)