- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02499601
CORolla® TAA for Heart Failure With Preserved Ejection Fraction (HFpEF) and Diastolic Dysfunction (DD)
October 7, 2020 updated by: CorAssist Cadiovascular Ltd.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ruti Hoefler, B.Sc
- Email: ruti@corassist.com
Study Locations
-
-
-
Haifa, Israel, 3109601
- Recruiting
- Rambam - health care campus
-
Contact:
- Anastasia Weis
- Phone Number: +972-4-7772048
- Email: A_WEIS@rambam.health.gov.il
-
Contact:
- Gal Gidron
- Phone Number: +972-4-7772048
- Email: G_GIDRON@rambam.health.gov.il
-
Principal Investigator:
- Gil Bolotin, M.D. Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
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)
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CORolla™ TAA Stand Alone
Single 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;
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with All-cause mortality and Serious Adverse Events (SAEAs)
Time Frame: 6 months
|
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. |
6 months
|
Incidence of in-hospital procedure success.
Time Frame: up ot 24 hour.
|
Success of the implant surgical procedure and ability to position the CORolla® TAA will be determined according to Implantation Rating Questionnaire.
|
up ot 24 hour.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of HF death and re-hospitalization due to HF (including IV diuretic)
Time Frame: 6 months
|
6 months
|
|
Rate of HF death and re-hospitalization due to HF (including IV diuretic)
Time Frame: 12 months
|
12 months
|
|
Rate, type and severity of procedure related and device-related events
Time Frame: 30 days
|
30 days
|
|
Rate of device related Major Adverse Cardiac and Neurological Events (MACNE)
Time Frame: up to 6 months
|
up to 6 months
|
|
Change in Quality of Life (QoL) Questionnaire
Time Frame: up to 24 months
|
Minnesota Living with Heart Failure.
|
up to 24 months
|
Change in New York Heart Association functional Class (NYHA f. Cl).
Time Frame: up to 24 months
|
up to 24 months
|
|
Change in exercise capacity as measured by the Six-Minute Walk test.
Time Frame: up to 24 months
|
up to 24 months
|
|
Device impact on diastolic dysfunction markers assessed by conventional echocardiography imaging and novel approach including Tissue Doppler Imaging (TDI).
Time Frame: up to 24 months
|
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].
|
up to 24 months
|
Change of Wedge pressure
Time Frame: up to 24 months
|
For safety assessment and impact of CORolla ® TAA therapy on this marker of diastolic dysfunction.
|
up to 24 months
|
Change in Pulmonary Capillary Wedge Pressure during handgrip/ergometry
Time Frame: up to 24 months
|
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.
|
up to 24 months
|
Change in exercise testing during echocardiography
Time Frame: up to 24 months
|
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.
|
up to 24 months
|
Change in VO2 Max
Time Frame: up to 24 months
|
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.
|
up to 24 months
|
Changes in cardiac medications, including daily diuretic dose.
Time Frame: up to 24 months
|
The dose of furosemide [mg/d] and thiazide [mg/d] before and after the procedure and during follow up will be recorded and compared.
|
up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Anticipated)
September 1, 2021
Study Completion (Anticipated)
September 1, 2024
Study Registration Dates
First Submitted
July 7, 2015
First Submitted That Met QC Criteria
July 15, 2015
First Posted (Estimate)
July 16, 2015
Study Record Updates
Last Update Posted (Actual)
October 8, 2020
Last Update Submitted That Met QC Criteria
October 7, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLD_CRL_0403
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diastolic Heart Failure
-
Emory UniversityUnknownDiastolic Heart Failure | Diastolic DysfunctionUnited States
-
University of VermontCompletedDiastolic Heart Failure | Diastolic Dysfunction | PacemakerUnited States
-
University of NebraskaTerminatedDiastolic Heart FailureUnited States
-
Arizona State UniversityMayo Clinic; University of AlbertaCompleted
-
University of Wisconsin, MadisonTerminatedDiastolic Heart FailureUnited States
-
University of PennsylvaniaCompletedHeart Failure | Diastolic Heart FailureUnited States
-
Chang Gung Memorial HospitalCompleted
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI); PfizerCompleted
-
St Vincent's University Hospital, IrelandCompletedThe Effect of Eplerenone and Atorvastatin on Markers of Collagen Turnover in Diastolic Heart FailureDiastolic Heart FailureIreland
-
Synvista Therapeutics, IncTerminatedDiastolic Heart FailureUnited States
Clinical Trials on CORolla™ TAA device
-
CorAssist Cadiovascular Ltd.UnknownDiastolic Heart Failure NYHA Class III-IV | Diastolic Dysfunction Secondary to Aortic StenosisItaly
-
Lifetech Scientific (Shenzhen) Co., Ltd.RecruitingAneurysm Thoracic | Dissection of Thoracic AortaArgentina, Italy, Germany, Greece, Russian Federation
-
Cook Group IncorporatedApproved for marketingAortic Aneurysm | Vascular Disease | Penetrating UlcerUnited States
-
Assistance Publique - Hôpitaux de ParisUnknown
-
Cook Research IncorporatedCompletedAortic Aneurysm | Vascular Disease | Penetrating UlcerUnited States, Japan, Germany, Italy, Sweden, United Kingdom
-
Medtronic Neurovascular Clinical AffairsCompletedIntracranial AneurysmUnited States, Canada
-
Medtronic Neurovascular Clinical AffairsRecruitingIntracranial Aneurysm | Ruptured AneurysmUnited States
-
Smart Medical Systems Ltd.CompletedIntestinal DiseasesUnited Kingdom
-
Medtronic Neurovascular Clinical AffairsCompletedIschemic StrokeUnited States
-
Spokane Joint Replacement CenterCompletedOsteoarthritis, HipUnited States