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

Not Applicable

Recruiting

• Conditions: Diastolic Heart Failure; Diastolic Dysfunction
• Interventions: Device: CORolla™ TAA device

• Registration Number: NCT02499601
• Lead Sponsor: CorAssist Cadiovascular Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-07
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-16
• Study Start: 2015-09
• Status Verified: 2020-06
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-08
• Primary Completion: 2021-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CORolla™ TAA Stand Alone	CORolla™ TAA device	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;

Primary Outcome Measures

Name	Time	Method
Number of participants with All-cause mortality and Serious Adverse Events (SAEAs)	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.
Incidence of in-hospital procedure success.	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.

Secondary Outcome Measures

Name	Time	Method
Device impact on diastolic dysfunction markers assessed by conventional echocardiography imaging and novel approach including Tissue Doppler Imaging (TDI).	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 \[cm/sec\].
Rate of HF death and re-hospitalization due to HF (including IV diuretic)	12 months
Rate of device related Major Adverse Cardiac and Neurological Events (MACNE)	up to 6 months
Changes in cardiac medications, including daily diuretic dose.	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.
Rate, type and severity of procedure related and device-related events	30 days
Change in New York Heart Association functional Class (NYHA f. Cl).	up to 24 months
Change of Wedge pressure	up to 24 months	For safety assessment and impact of CORolla ® TAA therapy on this marker of diastolic dysfunction.
Change in VO2 Max	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.
Change in Quality of Life (QoL) Questionnaire	up to 24 months	Minnesota Living with Heart Failure.
Change in exercise capacity as measured by the Six-Minute Walk test.	up to 24 months
Change in Pulmonary Capillary Wedge Pressure during handgrip/ergometry	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.
Change in exercise testing during echocardiography	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.

Trial Locations

Locations (1)

RAMBAM - Health Care Campus; 🇮🇱 Haifa, Israel