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

CorAssist Cadiovascular

Status: Enrolling

Conditions: Diastolic Dysfunction; Diastolic Heart Failure

Treatments: Device: CORolla™ TAA device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02499601

CLD_CRL_0403

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

CORolla™ TAA Stand Alone

Experimental group

Description:

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;

Treatment:

Device: CORolla™ TAA device