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Trial registered on ANZCTR


Registration number
ACTRN12610000656033
Ethics application status
Approved
Date submitted
9/08/2010
Date registered
11/08/2010
Date last updated
21/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
C-Pulse Implantable Counterpulsation Pump (ICP) Feasibility Study - A Heart Assist System
Scientific title
A prospective study to assess the safety and indications of performance of the C–Pulse Trademark (TM) System in relieving heart failure symptoms in patients with ACC/AHA Stage C, NYHA Class III-ambulatory Class IV heart failure.
Secondary ID [1] 252372 0
ClinicalTrials.gov - NCT00815880
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with American College of Cardiology (ACC)/ Americal Heart Association (AHA) Stage C, New York Heart Association (NYHA) Class III-ambulatory Class IV heart failure 257886 0
Condition category
Condition code
Cardiovascular 258048 258048 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sunshine Heart Inc. is sponsoring a prospective, multi-center trial to assess the safety and provide indications for performance of the Sunshine Heart C-Pulse TM System.

Sunshine Heart, Inc has proposed C-Pulse (TM), a novel ambulatory, non-obligatory, non-blood contacting extra-ascending aortic counterpulsation system. The C-Pulse (TM) System is designed to be implanted without the need for cardiopulmonary bypass or extensive dissection, to be able to be activated immediately, to augment heart function in a safe manner and to provide sustained relief from heart failure symptoms. It can be turned off safely, and similarly, in failure modes, is considered to have an associated low risk of death or disability, other than the recurrence of heart failure symptoms. C-Pulse (TM) is not an alternative to the heart, it is an augmentation device, and it does not preclude the use of therapies that provide full circulatory support such as heart transplantation or Left Ventricular Assist Devices (LVADs).

The C-Pulse (TM) System consists of a counterpulsation Cuff secured around the outside of the ascending aorta, the main blood vessel out of the heart. The Cuff and a heart signal sensing wire are attached to an external driver. The external Driver inflates and deflates the Cuff in sequence with the Electrocardiography (ECG) signal to assist heart function and improve the pumping capacity of the heart. The Cuff deflects the aorta in a "thumb-printing" manner which has been optimized to minimize aortic wall strain and maximize blood volume displacement per beat. The C-Pulse (TM) System is non-blood contacting, simple to insert, and can be turned on and off as required; all natural blood pathways are maintained - there is no exposure of foreign material to the bloodstream. The surgical procedure for implanatation may take 2 -4 hours. For the study, patients are required to be connected to the C-Pulse System for approximately 20 hours a day. The patient can safely turn the device on and off as required to perform functions of daily living, such as personal hygiene. It is acceptable to switch the device off for up to 15 minutes.
Intervention code [1] 256938 0
Treatment: Devices
Comparator / control treatment
There is no control for this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258905 0
Assess the risks with regard to the performance of the device as defined by the serious adverse event rates, under normal conditions of use. Serious adverse event rates will be assessed through information on adverse events collected throughout the study. Information will be collected through data linkage to patient medical records and scheduled patient check-ups.
Timepoint [1] 258905 0
From implantation to 5 years post implant
Primary outcome [2] 258906 0
Assess the potential benefits of C-Pulse as defined by improvements in Peak Oxygen Consumption (VO2), hemodynamic measures, quality of life and Heart Failure (HF) symptoms.

These outcomes will be assessed through maximal treadmill exercise testing, the Minnesota Living with Heart Failure Questionnaire and the Kansas City Questionnaire, New York Heart Association (NYHA) Classification of HF, Echocardiogram (ECG), Computer Tomography (CT), and Right Heart Catheterisation (RHC).
Timepoint [2] 258906 0
Peak VO2 will be assessed pre-implant and 6 months post implant.
NYHA and Quality of life questionnaires will be done pre implant and 1,3,6, 12, 18 months post-implant and annually therafter until the 5th year.

CT and RHC are conducted pre-implant and 6 months post-implant. ECG conducted pre implant and 1,3,6 months post-implant.
Secondary outcome [1] 265066 0
Further assess the potential risks with regard to the performance of the device as defined by the device failure rate, adverse event rates, adverse event attribution, re hospitalization rates, duration of support, and length of time to hospital discharge.

This will be assessed through data linkage to patient medical records and scheduled patient check-ups.
Timepoint [1] 265066 0
From implantation to 5 years post implant
Secondary outcome [2] 265067 0
Further assess the potential benefits of C-Pulse as defined by improvements in quality of life, fatigue impact scales, hemodynamics, average distance walked in the 6 minute hall walk test, and blood tests.

Quality of life will be assessed through specific patient questionnaires, the Minnesota Living with Heart Failure Questionnaire and the Kansas City Questionnaire.
Timepoint [2] 265067 0
The required data to assess the secondary outcomes will be taken pre-implant and 1, 3, 6, 12, 18 months and annually thereafter until the 5th year.
Secondary outcome [3] 265068 0
Assess the device usage. This will assessed through reports produced by the device driver.
Timepoint [3] 265068 0
From implantation to 5 years post implant

Eligibility
Key inclusion criteria
1. Patient has ACC/AHA Stage C heart failure and remains in NYHA Class III - ambulatory Class IV despite optimal medical therapy.
2. Patient has left ventricular ejection fraction less than or equal to 35%
3. Patient has had Cardiac Resynchronization Therapy (CRT) for at least 90 days prior to enrolment or is not indicated for a CRT device
4. Patient has had an implanted cardio–defibrillator (ICD) at least 30 days prior to enrolment or is not indicated for ICD implantation
5. Patient is at least 18 years of age and not older than 75 years
6. Patient six minute hall walk assessment between 100–350 meters
7. 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
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient has any evidence of :
a. ascending aortic calcification on posterior–anterior or lateral chest x–ray
OR
b. has atherosclerotic ascending aortic disease, specifically intimal thickening greater than 3mm or mobile atheroma (moderate) or mural calcification (severe)

2. 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

3. Patient aorta not conforming to specified dimensional constraints defined by Computer Tomography (CT) scan, most specifically mid ascending aortic outside diameter less than 29mm or greater than 40mm

4. Patient has severe mitral valve incompetence, grade 4+

5. Patient has moderate to severe aortic valve incompetence, grade 2–4+

6. Patient has systolic blood pressure less than 90 or greater than 140 mmHg

7. Patient has a Serum Sodium less than 130 mEq/L

8. Patient has a Estimated Glomelular Filtrate Rate (GFR) less than 40 ml/min/1.73 m2

9. Patient has any two of three of Bilirubin, aspartate aminotransferase enzyme (AST), alanine transaminase enzyme (ALT) greater than 3 times upper limit of normal for each institution

10. Patient has a serum Albumin less than 3.0 g/dL

11. Patient has Body Mass Index (BMI) less than 18 or greater than 40 kgm2

12. Men with Peak VO2 of greater than 18ml/kg/min or less than 10 ml/kg/min

13. Women with Peak VO2 of greater than 16 or less than 9 ml/kg/min

14. Patient has any active infection

15. Patient has had a myocardial infarction, stroke, transient ischemic attack, cardiac or other major surgery, in the 3 months prior to study enrollment.

16. Patient has severe Chronic Obstructive Pulmonary Disease (COPD) as evidenced by Forced Expiratory Volume (FEV1) less than or equal to 0.9 L/min

17. Patient requires a concomitant surgical procedure (i.e. Cornonary Artery Bypass Graft (CABG), Valve repair)

18. Patient is supported with a left ventricular assist device or intra–aortic balloon pump.

19. Severe right heart dysfunction with systemic venous congestion evidenced by clinical signs/symptoms such as Central Venous Pressure (CVP) greater than or equal to 20 mmHg , Cardiac Index < 2.0 l/min/m2, elevated liver function tests beyond three times the upper limit of normal with the presence of ascites.

20. Patient has reversible causes of heart failure that may be remedied by conventional surgery or other intervention

21. Patient is pregnant. Note: Negative pregnancy test required in all women of child bearing potential.

22. Patient has any other condition that, in the opinion of the investigators, would disqualify the patient for inclusion in the study, limits survival to less than one year, or not permit valid consideration

23. Patient is currently enrolled or has participated in the last 30 days in another therapeutic or interventional clinical study that is likely to confound study results or affect study outcome

24. Patient has symptomatic Carotid artery disease or asymptomatic disease with a stenosis greater than 70% as determined by Carotid Doppler Ultrasound.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3119 0
2010

Funding & Sponsors
Funding source category [1] 257389 0
Commercial sector/Industry
Name [1] 257389 0
Sunshine Heart Inc
Address [1] 257389 0
7651 Anagram Drive, Eden Praire MN 55344.
Country [1] 257389 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Sunshine Heart Inc
Address
7651 Anagram Drive, Eden Praire MN 55344.
Country
United States of America
Secondary sponsor category [1] 256628 0
None
Name [1] 256628 0
Address [1] 256628 0
Country [1] 256628 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259414 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 259414 0
Research Office
Level 6 deLacy Building
St Vincent's Hospital
390 Victoria Street
Darlinghurst, NSW, 2010
Ethics committee country [1] 259414 0
Australia
Date submitted for ethics approval [1] 259414 0
Approval date [1] 259414 0
09/04/2010
Ethics approval number [1] 259414 0
HREC/09/SVH/160

Summary
Brief summary
The C-Pulse System is a new Heart Assist Device that is currently being studied in seven hospitals in the United States under the Food and Drug Administration (FDA) guidelines
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31471 0
Address 31471 0
Country 31471 0
Phone 31471 0
Fax 31471 0
Email 31471 0
Contact person for public queries
Name 14718 0
Paul Cohen
Address 14718 0
DevDx Clinical Pty Ltd
Suite 408, 460 Pacific Highway,
St Leonards, NSW, 2065
Country 14718 0
Australia
Phone 14718 0
+61 2 99062984
Fax 14718 0
+61 2 85804613
Email 14718 0
paul@panco.com.au
Contact person for scientific queries
Name 5646 0
Paul Cohen
Address 5646 0
DevDx Clinical Pty Ltd
Suite 408, 460 Pacific Highway ,
St Leonards, NSW, 2065
Country 5646 0
Australia
Phone 5646 0
+61 2 99062984
Fax 5646 0
+61 2 85804613
Email 5646 0
paul@panco.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary