C-Pulse Implantable Counterpulsation Pump (ICP) - A Heart Assist Device

NCT01176370 | Terminated DMC

• 1 other identifier: PRO 02977 Rev - B
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The C-Pulse Study is evaluating the safety and performance of a new product for the treatment of heart failure. The product is designed to help reduce the symptoms of heart failure and help patients function better with daily activities. The study evaluates multiple measures of heart function and whether the patient's quality of life has been improved since the device implant. The patient will have several visits after the device implant to assess how well they are doing and to monitor any safety concerns.

Conditions

Heart Failure

Keywords

Heart Failure; Device; Implantable; Active; Class III and Class IV; Counterpulsation

Outcome Measures

Primary Outcomes (4)

• Percent of Patients with a Device-Related Adverse Event

  The primary safety endpoint is the composite device-related adverse event rate as defined by the percent of patients who experience at least one device-related adverse events out of the total number of patients.

  Through 6 months

• Quality of Life (QOL)

  improvement from baseline to 6-months post-implant. QOL as measured by the Minnesota Living with Heart Failure (MLWHF) questionnaire.

  6 months

• New York Heart Association (NYHA) Classification

  improvement from baseline to 6-months post-implant. Participant NYHA Classification at 6 month follow up. The NYHA Classification involved 4 classes. I No limitation of physical activity II Slight limitation of physical activity III Marked limitation of physical activity IV Unable to carry on any physical activity without discomfort

  6 months

• Improvement in 6 Minute Walk Test (6MWT)

  improvement from baseline to 6-months post-implant. The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.

  6 months

Secondary Outcomes (1)

• Further assess risks and benefits

  5-years

Study Arms (1)

Implantable Counterpulsation Therapy

EXPERIMENTAL

The study is a single arm study with up to 20 patients enrolled and implanted with implantable counterpulsation. Patients that meet eligibility will be enrolled and implanted into the treatment arm of the study. There is not a control arm in this feasibility study.

Device: C-Pulse™ (Implantable Counterpulsation Therapy)

Interventions

C-Pulse™ (Implantable Counterpulsation Therapy) DEVICE

C-Pulse System is an implantable, non-blood contacting, non-obligatory, heart assist device.

Also known as: C-Pulse, Implantable Counterpulsation Pump, Heart Assist System, Sunshine Heart C-Pulse ICP

Implantable Counterpulsation Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has ACC/AHA Stage C heart failure and remains in NYHA Class III - ambulatory Class IV despite optimal medical therapy.
• ACE inhibitor or ARB (Angiotensin Receptor Blocks) at least 30 days preceding implant or nitrate/hydralazine at the investigators discretion
• Beta-blocker for at least 90 days and stable for 30 days preceding implant
• Patient has left ventricular ejection fraction (LVEF) ≤ 35%
• Patient has had Cardiac Resynchronization Therapy (CRT) for at least 90 days prior to enrollment or is not indicated for a CRT device
• Patient has had an implanted cardio-defibrillator (ICD) at least 30 days prior to enrollment or is not indicated for ICD implantation.
• Patient is at least 18 years of age and not older than 75 years
• Patient six minute hall walk assessment between 100-350 meters
• Patient understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provide written informed consent prior to the procedure

You may not qualify if:

• Patient has any evidence of:
• Ascending aortic calcification on posterior-anterior or lateral chest x-ray at initial screening OR
• Atherosclerotic ascending aortic disease, specifically intimal thickening greater than 3mm or mobile atheroma (moderate) or mural calcification (severe) as detected by CT scan or echocardiography (Echo)
• Patient has ascending aorto-coronary artery bypass grafts, history of aortic dissection, Marfans disease or other connective tissue disorder or has had an aortic root replacement
• Patient aorta not conforming to specified dimensional constraints defined by CT scan, most specifically mid ascending aortic outside diameter less than 29mm or greater than 40mm
• Patient has severe mitral valve incompetence, grade 4+
• Patient has moderate to severe aortic valve incompetence, grade 2-4+
• Patient has systolic blood pressure less than 90 or greater than 140 mmHg
• Patient has a Serum Sodium less than 130 mEq/L
• Patient has a Estimated Glomerular Filtration Rate (GFR) less than 40 ml/min/1.73m2
• Patient has any two of three of Bilirubin, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) greater than three times upper limit of normal
• Patient has a serum Albumin less than 3.0 g/dL
• Patient has Body Mass Index (BMI) less than 18 or greater than 40 kg/m2
• Patient has any active infection
• Patient has had a myocardial infarction (MI), stroke, transient ischemic attack (TIA), cardiac or other major surgery, in the 90 days prior to enrollment

Sponsors & Collaborators

• Nuwellis, Inc.: lead

Study Sites (1)

McGill University Health Centre - Royal Victoria Hospital

Montreal, Quebec, QcH3A 1A1, Canada

Location

MeSH Terms

Conditions

Heart Failure; Motor Activity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Renzo Cecere, MD

  McGill University Health Centre, Royal Victoria Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: All enrolled/consented subjects receive study device: C-Pulse™ (Implantable Counterpulsation Therapy).

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 6, 2010
• Study Start: June 21, 2010
• Primary Completion: April 30, 2015
• Study Completion: April 30, 2015
• Last Updated: August 15, 2023

Record last verified: 2023-08

Locations

CA (1)