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

Diastolic Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02499601
• Other study ID #: CLD_CRL_0403
• Status: Recruiting
• Phase: N/A
• Start date: September 2015
• Est. completion date: September 2024

Study information

• Verified date: June 2020
• Source: CorAssist Cadiovascular Ltd.
• Contact: Ruti Hoefler, B.Sc
• Email: ruti[@]corassist.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 2024
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Clinical criteria:

1. Adult (age > 18 years)

2. Diagnosis of heart failure with preserved ejection fraction

3. NYHA F. Class III or IV or documented history of at least two heart failure hospitalization in the past year prior to enrollment.

4. No contraindication for anticoagulation and antiplatelet treatment.

5. Optimal medical cardiovascular pharmacotherapy with stable doses for at least 4 weeks (not including diuretics)

6. Pulmonary Wedge pressure > 15 mmHg documented by right heart catheterization at enrollment.

7. Patient understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed

8. Patient is able and willing to adhere to the required follow-up visits and testing

9. Minimal endocardial height from Apex to Mitral Annulus > 60mm at end systole

Echocardiographic criteria:

1. Left ventricular ejection fraction=50%

2. HFpEF diagnosis according to ESC 2016 guidelines

3. No evidence of intra-cardiac thrombus

Cardiovascular disease:

1. Implanted or planned implantation of defibrillator devices such as ICD cardiac resynchronization device (CRT-D) or left ventricular assist device (LVAD).

2. Within the past 3 months - Acute myocardial infarction (AMI), cerebral vascular accident (CVA), or Transient Ischemic Attack (TIA).

3. History of thrombus within the previous 3 months.

4. 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.

5. Significant valvular disease classified as

• Moderate or severe aortic stenosis/regurgitation

• Moderate or severe mitral stenosis

• Severe mitral regurgitation

6. Hypertrophic cardiomyopathy

7. History of pericardial disease.

8. HF attributed to Cor pulmonale or other cause of isolated right heart failure.

9. Moderate to severe right ventricle failure or right ventricular myocardial infarction.

10. Infiltrative heart disease including amyloidosis.

Non-cardiovascular disease:

1. Prior surgery, radiation, or thoracic surgery limiting the ability to place the device.

2. Moderate to severe asthma or COPD, or severe restrictive lung disease.

3. Severe chronic renal failure indicated by MDRD GFR <30 mL/min/1.73 m2.

4. Liver impairment addressed by bilirubin > 2 mg/dl and serum albumin <3 g/dL

5. Severe anemia addressed by Hb concentration <9 gr/l.

6. Solid organ or hematologic transplant.

7. Previous Trans Apical procedures/implantation.

Miscellaneous conditions:

1. Co-morbid condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.

2. 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).

3. Participating in another treatment investigational study.

4. 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.

Related Conditions & MeSH terms

• Diastolic Dysfunction
• Diastolic Heart Failure
• Heart Failure
• Heart Failure, Diastolic

Intervention

Device:
• CORolla™ TAA device

Locations

Country	Name	City	State
Israel	RAMBAM - Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
CorAssist Cadiovascular Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Primary	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.	up ot 24 hour.
Secondary	Rate of HF death and re-hospitalization due to HF (including IV diuretic)		6 months
Secondary	Rate of HF death and re-hospitalization due to HF (including IV diuretic)		12 months
Secondary	Rate, type and severity of procedure related and device-related events		30 days
Secondary	Rate of device related Major Adverse Cardiac and Neurological Events (MACNE)		up to 6 months
Secondary	Change in Quality of Life (QoL) Questionnaire	Minnesota Living with Heart Failure.	up to 24 months
Secondary	Change in New York Heart Association functional Class (NYHA f. Cl).		up to 24 months
Secondary	Change in exercise capacity as measured by the Six-Minute Walk test.		up to 24 months
Secondary	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].	up to 24 months
Secondary	Change of Wedge pressure	For safety assessment and impact of CORolla ® TAA therapy on this marker of diastolic dysfunction.	up to 24 months
Secondary	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.	up to 24 months
Secondary	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.	up to 24 months
Secondary	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.	up to 24 months
Secondary	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.	up to 24 months

External Links

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