C-Pulse IDE Feasibility Study- A Heart Assist System

NCT00815880 | Completed Results DMC

• 1 other identifier: PRO02291
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 6

Brief Summary

The C-Pulse Feasibility 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)

• Number of Surviving Participants That Completed the Study

  Amount of participants that did not exit study for reasons including worsening heart failure resulting in hospitalization, LVAD implantation, study withdrawal or death.

  5 Years

• Six Minute Walk Test

  6MWT in distance (meters).

  6 Months

• Cardiopulmonary Exercise Testing

  CPX is performed on a treadmill and carried out to a symptomatic maximum. Minute oxygen consumption (VO2; ml/min) and minute carbon dioxide production (VCO2; ml/min) are measured using a breath-by-breath respiratory gas analyzer. The Respiratory Exchange Ratio (RER) is calculated as VCO2/VO2. A peak RER of ≥1.10 is generally considered an indication of excellent subject effort during CPX. Achievement of a peak RER \<1.00 in a CPX that is terminated by subject request, absent any electrocardiographic or hemodynamic abnormalities, generally reflects submaximal cardiovascular effort.

  6 Months

• Kansas City Cardiomyopathy Questionnaire (KCCQ)

  Overall KCCQ score, a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life (QOL) within a 2-week recall period. Scores range from 0-100, in which higher scores reflect better health status.The KCCQ instrument may be used by medical device companies and sponsor-investigators for evaluation of safety and effectiveness for heart failure medical devices to support regulatory submissions. The KCCQ instrument, specifically the Symptom Domain Score, Physical Limitation Domain Score, Social Limitation Domain Score, Quality of Life Domain Score and Overall Summary Score, can be used as a component of a composite primary endpoint or secondary endpoint in a feasibility or pivotal clinical trial evaluating heart failure medical devices.

  6 Months

Secondary Outcomes (1)

• New York Heart Association (NYHA) Classification

  6 Months

Study Arms (1)

Implantable Counterpulsation Therapy

EXPERIMENTAL

The primary study population will include 20 patients enrolled and implanted with C-Pulse. This expansion protocol will allow up to 40 patients to be enrolled and implanted. Patients that meet eligibility will be enrolled and implanted into the treatment arm of the study. These patients will receive the C-Pulse System Implant as intervention therapy. There is not a control arm in this feasibility study.

Device: C-Pulse™ (Implantable Counterpulsation Therapy)

Interventions

C-Pulse™ (Implantable Counterpulsation Therapy) DEVICE

Implantation and activation of counterpulsation therapy for the full duration of the study period. The device may be turned off briefly for personal hygiene, etc.

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

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
• Men with Peak Oxygen Uptake (VO2) of greater than 18 ml/kg/min or less than 10 ml/kg/min OR -Women with Peak VO2 of greater than 16 ml/kg/min or less than 9 ml/kg/min
• Patient has any active infection

Sponsors & Collaborators

• Nuwellis, Inc.: lead

Study Sites (6)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

St. Paul Heart Clinic

Saint Paul, Minnesota, 55102, United States

Location

Mid America Heart Institute-Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

• Abraham WT, Aggarwal S, Prabhu SD, Cecere R, Pamboukian SV, Bank AJ, Sun B, Pae WE Jr, Hayward CS, McCarthy PM, Peters WS, Verta P, Slaughter MS; C-Pulse Trial Study Group. Ambulatory extra-aortic counterpulsation in patients with moderate to severe chronic heart failure. JACC Heart Fail. 2014 Oct;2(5):526-33. doi: 10.1016/j.jchf.2014.04.014.

  PMID: 25301151 DERIVED

MeSH Terms

Conditions

Heart Failure; Motor Activity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Results Point of Contact

• Title: Audrey Singh
• Organization: CHF Solutions, Inc.

audrey.singh@chf-solutions.com

952-345-4217

Study Officials

• William T Abraham, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Pat McCarthy, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: The C-Pulse System is indicated for use in subjects with moderate to severe heart failure who are refractory to optimal medical therapy

Study Record Dates

• First Submitted: December 30, 2008
• First Posted: December 31, 2008
• Study Start: September 10, 2008
• Primary Completion: May 7, 2018
• Study Completion: September 7, 2018
• Last Updated: August 24, 2023
• Results First Posted: August 24, 2023

Record last verified: 2023-08

Locations

US (6)