C-Pulse® System: A Heart Assist Device Clinical Study

• Register: ClinicalTrials.gov
• Last refreshed on: 22 January 2024
• Main ID: NCT01740596
• Date of registration: 28/11/2012
• Prospective Registration: No
• Primary sponsor: Nuwellis, Inc.
• Public title: C-Pulse® System: A Heart Assist Device Clinical Study COUNTER-HF
• Scientific title: C-Pulse Heart Assist Device pivOtal stUdy treatiNg paTients With modERate to Severe Heart Failure C-Pulse® System: A Heart Assist Device Pivotal IDE Study
• Date of first enrolment: September 12, 2012
• Target sample size: 38
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT01740596
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: William Abraham, MD
• Affiliation: Ohio State University

• Name: Margarita T Camacho, MD
• Affiliation: Newark Beth Israel

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Left ventricular ejection fraction (LVEF) = 35% (by transthoracic ECHO within 90 days
prior to randomization)

2. ACC/AHA Stage C and NYHA III to ambulatory Class IV

3. Age = 18 years

4. Must have cardiac resynchronization therapy (CRT) when clinically indicated, implanted
=90 days prior to randomization.

5. Must have an implanted cardio-defibrillator (ICD) when clinically indicated, implanted
at least 30 days prior to randomization.

Note: If a subject is clinically indicated for an ICD but refuses the ICD, he/she may
be enrolled. Please document the refusal of the ICD in the medical record and the
eCRFs.

6. Patient must be on stable, up-titrated medical therapy as recommended according to
current guidelines (Circulation. 2009; 119 (12): 1977-2016) which minimally includes:

- ACE-inhibitor (ACE-I) at stable doses for 1 month prior to enrollment, if
tolerated, AND

- a beta blocker (carvedilol, sustained release metoprolol succinate, or
bisoprolol) for 3 months prior to enrollment, if tolerated, with a stable
up-titrated dose for 1 month prior to enrollment.

- This also includes an Angiotensin II Receptor Blocker (ARB) at stable doses for 1
month prior to enrollment, if tolerated, when ACE-I is not tolerated.

- Stable is defined as no more than a 100% increase or a 50% decrease in dose. If
the patient is intolerant to ACE-I, ARB, or beta blockers, documented evidence
must be available.

- In those intolerant to both ACE-I and ARB, combination therapy with hydralazine
and oral nitrate should be considered. Therapeutic equivalence for ACE-I
substitutions is allowed within the enrollment stability timelines.

- Aldosterone inhibitor therapy should be added. Eplerenone requires dosage
stability for 1 month prior to enrollment.

- Diuretics may be used as necessary to keep the patient euvolemic.

7. Functional limitation due to heart failure as defined by a 6 Minute Walk test of = 175
= 375 meters, measured within 30 days prior to randomization

8. At least one hospitalization for decompensated heart failure as defined below, while
on heart failure medications, within 12 months prior to randomization or BNP level >
300 or NTproBNP > 1500

Heart failure related hospitalization is defined by the following:

- signs and symptoms of worsening heart failure; and

- treatment with intravenous heart failure therapy (including but not limited to
diuretic or inotropic therapy) and

- a minimum of one date change in the hospital

9. Patient understands the nature of the procedure and on-going device therapy, is
willing to comply with associated follow-up evaluations, and provide written informed
consent prior to the procedure.

Exclusion Criteria:

1. Any evidence, as assessed within 90 days prior to enrollment, of either:

1. Ascending aortic calcification on posterior-anterior or lateral chest x-ray

2. Calcific ascending aortic disease as detected by non-contrast CT scan

3. Ascending aorto-coronary artery bypass grafts, history of aortic dissection,
Marfans disease or other connective tissue disorder or repaired aortic
coarctation OR

4. Has had an ascending aortic composite graft or root replacement

2. Aorta not conforming to specified dimensional constraints defined by CT scan, most
specifically mid ascending aortic outside diameter less than 28 mm or greater than 42
mm

3. Inotrope dependence - inability to wean from inotropic therapy

4. ACC/AHA Stage D heart failure or non-ambulatory NYHA Class IV subject

5. Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, pericardial
disease, amyloidosis, active myocarditis, diastolic heart failure or technically
challenging congenital heart disease

6. Reversible cause of heart failure that may be remedied by conventional surgery or
other intervention

7. Moderate to severe aortic insufficiency (= 2+)

8. ST elevation myocardial infarction (STEMI) within 30 days prior to randomization

9. Cardiac surgery within 90 days prior to randomization

10. Prior cardiac transplantation, left ventricular reduction surgery, passive restraint
device or surgically implanted left ventricular assist device

11. Anticipated concomitant cardiac surgical procedure

12. Serum creatinine = 2.5mg/dL or any form of dialysis within 30 days prior to
randomization

13. Evidence of intrinsic hepatic disease as defined as biopsy proven liver cirrhosis; or
liver enzyme values (AST, ALT or total bilirubin) that are > 3 times the upper limit
of normal within 30 days prior to randomization

14. Patient has severe intrinsic pulmonary disease in judgment of the investigator

15. Body Mass Index (BMI) < 18 or > 45 kg/m2

16. Suspected or active systemic infection

1. Within 14 days prior to randomization and

2. Evidenced by positive culture, antibiotics for empiric treatment or elevated WBC
> 12K and temperature >38o C

17. Stroke or transient ischemic attack (TIA) within the 90 days prior to randomization;
or > 80% carotid stenosis as determined by carotid Doppler ultrasound within 90 days
prior to randomization

18. Positive serum pregnancy test, for women of childbearing potential

19. Patient has a condition, other than heart failure, which would limit survival to less
than 2 years

20. Patient is currently enrolled or has participated in the last 30 days in another
therapeutic or interventional clinical study

21. Patient demonstrates compliance issues that in the opinion of the investigator could
interfere with the ability to manage the therapy (i.e. uncontrolled diabetes, mental
health issues, etc.)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure

Intervention(s)

Device: C-Pulse® System Counterpulsation

Primary Outcome(s)

Primary Safety Outcome [Time Frame: 4 Years Follow-up]

Secondary Outcome(s)

Improvement in KCCQ Score at 12-months. [Time Frame: 12-months]

Improvement in LVEF at 12 Months. [Time Frame: 12-months]

Improvement in 6 Minute Hall Walk (6MW) at 12-months [Time Frame: 12-months]

Secondary ID(s)

PRO 03970-C

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/01/2024
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01740596