AzTrials
AzTrials

Diastolic Heart Failure NYHA Class III-IVNCT01956526

CORolla™ TAA for Heart Failure and Preserved Ejection Fraction and Diastolic Dysfunction

A study testing CORolla™ TAA device in people with Diastolic Heart Failure NYHA Class III-IV and Diastolic Dysfunction Secondary to Aortic Stenosis, run by CorAssist Cadiovascular Ltd. at 2 sites in Italy.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

The study purpose is to evaluate the safety and feasibility of the CORolla™ TAA in two treatment groups, "CORolla™ Stand-alone group" and " AVR \& CORolla™ Add on group". 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
12 participants
Where
2 sitesItaly
Study dates
Aug 2013to Sep 2017
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 systolic function according with ESC 2008 Guidelines (ejection fraction ≥ 50%)
  • NYHA F. Class III or IV symptoms with history of previous heart failure hospitalization in the last year
  • Able to sign informed consent and return for follow-up visits.
  • No contraindication for anticoagualation and antiplatelet treatment.
Show all 16Show fewer
  • Cardiac medications unchanged for greater than 4 weeks (not including diuretics)
  • Pulmonary Wedge pressure > 15 mmHg documented by right heart catheterization at enrollment.
  • Echocardiographic criteria
  • Preserved regional wall motion (no wall motion abnormalities).
  • Left ventricular ejection fraction ≥ 50%
  • LV end-diastolic volume index (LVEDVI) <97 ml/m2.
  • Left Atrial Volume Index: (LAVi >29 ml/m2).
  • E/E' ratio ( mean of septal and lateral ) ≥12 (applicable only to patients with sinus rhythm)
  • No intra-cardiac thrombus.
  • Minimal endocardial height from Apex to Mitral Annulus ≥ 70mm.

Who cannot join

  • Cardiovascular disease
  • Uncontrolled HTN defined as > 140/90 mmHg, or >160/90 mmHg for patients on 3-drug therapy
  • Current or anticipated need for ICD, currently implanted with a cardiac resynchronization device (CRT), left ventricular assist device (LVAD).
  • Within the past 3 months - Acute myocardial infarction (AMI), cerebral vascular accident (CVA), Transient Ischemic Attack (TIA) , Percutaneous coronary intervention (PCI or transmyocardial laser revascularization (TMR or PMR)
  • Valvular disease (unless add - on to aortic valve replacement due to aortic stenosis)
  • Hypertrophic cardiomiopathy
Show all 28Show fewer
  • Pericardial disease
  • Cor pulmonale or other cause of isolated right heart failure.
  • Non reversible pulmonary hypertension.
  • Right ventricle failure or right ventricular myocardial infarction.
  • Infiltrative heart disease
  • Non-cardiovascular disease
  • Non-cardiovascular condition limiting ability to assess the 6-minute hall walk test
  • Prior surgery, radiation, or thoracic surgery limiting the ability to place the device
  • Body mass index of greater than 40
  • Uncontrolled hyperglycemic status as addressed by HbA1c >8.5%
  • Asthma COPD (e.g. FEV1 <1.5 liter), 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 or pseudo- colinesterasis plasma concentration < 1500 IU and/or abnormal coagulative profile
  • Severe anemia addressed by Hb concentration <10 gr/l.
  • Solid organ or hematologic transplant.
  • Previous Trans Apical procedures/implantation
  • Miscellaneous conditions
  • Unwilling to fulfill the protocol medication compliance, testing, and follow-up requirements
  • 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 child bearing potential must have a negative serum pregnancy test within two weeks prior to enrollment, or be using hormonal contraceptives or intrauterine devices)
  • Enrolled in another 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

Trial locations and contacts

2 sites in 1 country.

Lea Lak, M.D. contact

+972 9 9554500 ext. 106

lea@corassist.com

Italy2 sites, 2 recruiting

  • Spedali Civili - Brescia Hospital

    Brescia, 25123

    Claudio Muneretto, M.D. Prof., 39 030 3996401

    Laura Tononi

    Recruiting

  • Multimedica

    Milan, 20099

    Edoardo Gronda, M.D. Prof., +39 0224209460

    Edoardo Gronda, M.D. Prof.

    Not yet recruiting

Other trials in Italy

About this study

The study purpose is to evaluate the safety and feasibility of the CORolla™ TAA in two treatment groups, "CORolla™ Stand-alone group" and " AVR \& CORolla™ Add on group".

Being tested
CORolla™ TAA device
Keywords
Heart Failure with Preserved Ejection Fraction (HFpEF), Diastolic Heart Failure (DHF), Diastolic Dysfunction (DD)
Medical subject headings
Heart Failure, Diastolic

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 NCT01956526
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
AVR and CORolla™ TAA Add On groupExperimentalpatients who require aortic valve replacement (AVR) due to aortic stenosis and have diastolic dysfunction will receive the CORolla™ TAA device.
Receives: Device: CORolla™ TAA device
AVR and CORolla ADD On - ControlNo interventionpatients who require only the aortic valve replacement (AVR) due to aortic stenosis and have diastolic dysfunction.

What is being measured

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

  1. Cardiovasculare related SAEs

    Investigational device safety with the intended study population with respect to 12 months follow up will be demonstrated using the following:

    Cardiovascular mortality and morbidity reports at 30 days post surgery.

    Serious adverse events: death, arrhythmia, CVA, AMI, bleeding and valve injury at 12 months post-surgery.

    Measured: 12 month post surgery

Secondary outcomes (7)

  1. feasibility

    Change in Quality of Life (QoL): Minnesota Living with Heart Failure.

    Measured: up to 36 month post surgery

  2. Feasibility

    Change in NYHA f. class

    Measured: up to 36 month post surgery

  3. Feasibility

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

    Measured: up to 36 month post surgery

  4. Feasibility

    Composite rate of HF death and re-hospitalization at 6 months and 1 year.

    Measured: Up to 36 month post surgery

  5. Feasibility

    Impact of CORolla™ TAA therapy on markers of diastolic dysfunction assessed by conventional echocardiography imaging (e.g LAVI index etc)and novel approach including Tissue Doppler Imaging (TDI)

    Measured: up to 36 month post surgery

  6. Feasibility

    Change of Wedge pressure - for safety assessment and impact of CORolla™ TAA therapy on this marker of diastolic dysfunction

    Measured: up to 36 month post surgery

  7. Feasibility

    Changes in cardiac medical therapy including daily diuretic dose

    Measured: up to 36 month post surgery

Timeline

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

  1. First posted8 Oct 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionSep 2015 (estimated)
  4. Study completionSep 2017 (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
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01956526
Sponsor's protocol ID
CLD CRL 0403
Status last verified
Oct 2013
First submitted
12 Aug 2013
Last updated
8 Oct 2013
Results posted
No

Publications

  • Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Stromberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K; ESC Committee for Practice Guidelines (CPG). ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J. 2008 Oct;29(19):2388-442. doi: 10.1093/eurheartj/ehn309. Epub 2008 Sep 17. No abstract available.

    PubMed 18799522

  • Paulus WJ, Tschope C, Sanderson JE, Rusconi C, Flachskampf FA, Rademakers FE, Marino P, Smiseth OA, De Keulenaer G, Leite-Moreira AF, Borbely A, Edes I, Handoko ML, Heymans S, Pezzali N, Pieske B, Dickstein K, Fraser AG, Brutsaert DL. How to diagnose diastolic heart failure: a consensus statement on the diagnosis of heart failure with normal left ventricular ejection fraction by the Heart Failure and Echocardiography Associations of the European Society of Cardiology. Eur Heart J. 2007 Oct;28(20):2539-50. doi: 10.1093/eurheartj/ehm037. Epub 2007 Apr 11.

    PubMed 17428822

Questions about this trial

What is this clinical trial studying?

A study testing CORolla™ TAA device in people with Diastolic Heart Failure NYHA Class III-IV and Diastolic Dysfunction Secondary to Aortic Stenosis, run by CorAssist Cadiovascular Ltd. at 2 sites in Italy.

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 16 inclusion and 28 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 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. 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 Lea Lak, M.D. (+972 9 9554500 ext. 106, lea@corassist.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovasculare related SAEs (time frame: 12 month post surgery). 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 NCT01956526, which also lists 2 linked publications.

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 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in