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Diastolic Heart FailureNCT02499601

CORolla® TAA for Heart Failure With Preserved Ejection Fraction (HFpEF) and Diastolic Dysfunction (DD)

A study testing CORolla™ TAA device in people with Diastolic Heart Failure and Diastolic Dysfunction, run by CorAssist Cadiovascular Ltd. at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study objective is to demonstrate safety and feasibility of the CORolla® TAA during 12 months of follow up, and to evaluate the performance of the therapy in relieving symptoms and restore diastolic function in patients with heart failure and preserved ejection fraction. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CORolla™ TAA device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteIsrael
Study dates
Sep 2015to Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical criteria:
  • Adult (age > 18 years)
  • Diagnosis of heart failure with preserved ejection fraction
  • NYHA F. Class III or IV or documented history of at least two heart failure hospitalization in the past year prior to enrollment.
  • No contraindication for anticoagulation and antiplatelet treatment.
  • Optimal medical cardiovascular pharmacotherapy with stable doses for at least 4 weeks (not including diuretics)
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  • Pulmonary Wedge pressure > 15 mmHg documented by right heart catheterization at enrollment.
  • Patient understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
  • Patient is able and willing to adhere to the required follow-up visits and testing
  • Minimal endocardial height from Apex to Mitral Annulus > 60mm at end systole
  • Echocardiographic criteria:
  • Left ventricular ejection fraction≥50%
  • HFpEF diagnosis according to ESC 2016 guidelines
  • No evidence of intra-cardiac thrombus
  • Cardiovascular disease:
  • Implanted or planned implantation of defibrillator devices such as ICD cardiac resynchronization device (CRT-D) or left ventricular assist device (LVAD).
  • Within the past 3 months - Acute myocardial infarction (AMI), cerebral vascular accident (CVA), or Transient Ischemic Attack (TIA).
  • History of thrombus within the previous 3 months.
  • Coronary Artery Bypass Surgery (CABG), valve replacement or repair, aortic surgery or percutaneous coronary intervention (PCI in the past 3 months or planned/anticipated within the coming 6 months. Patients with mechanical valve replacement or CABG performed more than 3 months before may be eligible for enrollment.
  • Significant valvular disease classified as
  • Moderate or severe aortic stenosis/regurgitation
  • Moderate or severe mitral stenosis
  • Severe mitral regurgitation
  • Hypertrophic cardiomyopathy
  • History of pericardial disease.
  • HF attributed to Cor pulmonale or other cause of isolated right heart failure.
  • Moderate to severe right ventricle failure or right ventricular myocardial infarction.
  • Infiltrative heart disease including amyloidosis.
  • Non-cardiovascular disease:
  • Prior surgery, radiation, or thoracic surgery limiting the ability to place the device.
  • Moderate to severe asthma or COPD, or severe restrictive lung disease.
  • Severe chronic renal failure indicated by MDRD GFR <30 mL/min/1.73 m2.
  • Liver impairment addressed by bilirubin > 2 mg/dl and serum albumin <3 g/dL
  • Severe anemia addressed by Hb concentration <9 gr/l.
  • Solid organ or hematologic transplant.
  • Previous Trans Apical procedures/implantation.
  • Miscellaneous conditions:
  • Co-morbid condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.
  • Pregnancy at the time of enrollment. (Women of childbearing potential must have a negative serum pregnancy test within two weeks prior to enrollment, or be using hormonal contraceptives or intrauterine devices).
  • Participating in another treatment investigational study.
  • A history of alcohol abuse, drug addiction, or other psychosocial condition that would preclude successful participation, or clear judgment and informed consent in the opinion of the Principal Investigator.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Ruti Hoefler, B.Sc contact

ruti@corassist.com

Israel1 site, 1 recruiting

  • RAMBAM - Health Care Campus

    Haifa, 3109601

    Anastasia Weis, +972-4-7772048, A_WEIS@rambam.health.gov.il

    Gal Gidron, +972-4-7772048, G_GIDRON@rambam.health.gov.il

    Recruiting

Other trials in Israel

About this study

Official title: CORolla® TAA for Heart Failure With Preserved Ejection Fraction (HFpEF) and Diastolic Dysfunction (DD) Safety and Feasibility

The study objective is to demonstrate safety and feasibility of the CORolla® TAA during 12 months of follow up, and to evaluate the performance of the therapy in relieving symptoms and restore diastolic function in patients with heart failure and preserved ejection fraction.

Being tested
CORolla™ TAA device
Keywords
Heart Failure with Preserved Ejection Fraction (HFpEF), Heart Failure (HF), New York Heart Association functional Class (NYHA f. Cl)
Medical subject headings
Heart Failure, Diastolic, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CORolla™ TAA deviceDevice

Study groups in NCT02499601
Study groupRoleWhat they receive
CORolla™ TAA Stand AloneExperimentalSingle arm study design including with patients with isolated HFpEF, in NYHA f. Cl. III-IV. These patients will receive the CORolla™ TAA device. For assessments of results, intra-patient comparisons of pre-procedure and follow-up data will be performed;
Receives: Device: CORolla™ TAA device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with All-cause mortality and Serious Adverse Events (SAEAs)

    Investigational device safety with the intended study population with respect to 6 months follow up will be demonstrated using the following:

    All-cause mortality and Serious Adverse Events (SAEAs) throughout 6 months post-surgery.

    Measured: 6 months

  2. Incidence of in-hospital procedure success.

    Success of the implant surgical procedure and ability to position the CORolla® TAA will be determined according to Implantation Rating Questionnaire.

    Measured: up ot 24 hour.

Secondary outcomes (13)

  1. Rate of HF death and re-hospitalization due to HF (including IV diuretic)

    Measured: 6 months

  2. Rate of HF death and re-hospitalization due to HF (including IV diuretic)

    Measured: 12 months

  3. Rate, type and severity of procedure related and device-related events

    Measured: 30 days

  4. Rate of device related Major Adverse Cardiac and Neurological Events (MACNE)

    Measured: up to 6 months

  5. Change in Quality of Life (QoL) Questionnaire

    Minnesota Living with Heart Failure.

    Measured: up to 24 months

  6. Change in New York Heart Association functional Class (NYHA f. Cl).

    Measured: up to 24 months

  7. Change in exercise capacity as measured by the Six-Minute Walk test.

    Measured: up to 24 months

  8. Device impact on diastolic dysfunction markers assessed by conventional echocardiography imaging and novel approach including Tissue Doppler Imaging (TDI).

    Composite measure: Left atrial volume index [ml/m^2], Early mitral flow velocity E [ml/sec], Mitral flow velocity during atrial systole A [ml/sec], E/A ratio, Mitral annular velocity e' [mm/sec], Declaration time [msec], E/e' [ml/mm], Left ventricular mass [gr], Ejection fiction [%], Pulmonary venous flow [m/sec], Transmitral flow propagation velocity [cm/sec].

    Measured: up to 24 months

  9. Change of Wedge pressure

    For safety assessment and impact of CORolla ® TAA therapy on this marker of diastolic dysfunction.

    Measured: up to 24 months

  10. Change in Pulmonary Capillary Wedge Pressure during handgrip/ergometry

    Applicable only to patients who are in a clinical condition that enables them to have the test and at sites that have the experience and the capabilities to perform this test.

    Measured: up to 24 months

  11. Change in exercise testing during echocardiography

    Composite measure: Maximal exercise tolerance defined as the number of metabolic equivalent (METs) at baseline and maximal: Early mitral flow velocity E [ml/sec], Mitral annular velocity e' [mm/sec] and E/e' [ml/mm]. Applicable only to patients who are in a clinical condition that enables them to have the test and at sites that have the experience to perform this test.

    Measured: up to 24 months

  12. Change in VO2 Max

    Applicable only to patients who are in a clinical condition that enables them to have the test and at sites that have the experience and the capabilities to perform this test.

    Measured: up to 24 months

  13. Changes in cardiac medications, including daily diuretic dose.

    The dose of furosemide [mg/d] and thiazide [mg/d] before and after the procedure and during follow up will be recorded and compared.

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionSep 2021 (estimated)
  4. Study completionSep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02499601
Sponsor's protocol ID
CLD_CRL_0403
Status last verified
Jun 2020
First submitted
7 Jul 2015
Last updated
8 Oct 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing CORolla™ TAA device in people with Diastolic Heart Failure and Diastolic Dysfunction, run by CorAssist Cadiovascular Ltd. at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 41 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ruti Hoefler, B.Sc (ruti@corassist.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with All-cause mortality and Serious Adverse Events (SAEAs) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02499601.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020; AzTrials last refreshed its copy on 31 Oct 2026.

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