Prospective Study of the BioVentrix PliCath HF™ System for the Treatment of Ischemic Cardiomyopathy

NCT01568138 | Completed DMC

• 1 other identifier: 20032-P
• Study Type: interventional
• Target: 26
• Locations: 4 countries
• Sites: 4

Brief 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).

Conditions

Heart Failure

Keywords

Ventricular Remodeling

Outcome Measures

Primary Outcomes (1)

• Assessment of overall rate of serious adverse device effects

  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.

  12 Months Post-operative

Secondary Outcomes (1)

• Assessment of overall rate of serious adverse events

  12 Months post-operative

Interventions

PliCath HF System DEVICE

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.

Also known as: Epicardial Catheter-based Ventricular Restoration, Left or Surgical Ventricular Reconstruction, Dor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 80
• % ≥ LVEF ≤ 45%
• NYHA FC II-III
• 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
• Agree to required follow-up visits

You may not qualify if:

• 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

Sponsors & Collaborators

• BioVentrix: lead
• Ohio State University: collaborator
• Centro Diagnostico Italiano: collaborator
• Advance Research Associates: collaborator

Study Sites (4)

Pauls Stradins Hospital

Riga, Latvia

Location

Santariskiu Klinikus

Vilnius, Lithuania

Location

Jagiellonian University Hospital

Krakow, Poland

Location

Bakoulev Institute

Moscow, Russia

Location

Related Links

• Sponsor company web site

MeSH Terms

Conditions

Heart Failure; Ventricular Remodeling

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

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: August 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 11, 2021

Record last verified: 2021-03

Locations

RU (1); PL (1); LA (1); LI (1)