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

Not Applicable

• Conditions: Diastolic Heart Failure NYHA Class III-IV; Diastolic Dysfunction Secondary to Aortic Stenosis
• Interventions: Device: CORolla™ TAA device

• Registration Number: NCT01956526
• Lead Sponsor: CorAssist Cadiovascular Ltd.

Brief 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".

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-12
• Status Verified: 2013-10
• Study First Submitted QC: 2013-10-07
• Last Update Submitted: 2013-10-07
• Study First Posted: 2013-10-08
• Last Update Posted: 2013-10-08
• Primary Completion: 2015-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• 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.
  • 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.

Exclusion Criteria

• 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
  • 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

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;
AVR and CORolla™ TAA Add On group	CORolla™ TAA device	patients who require aortic valve replacement (AVR) due to aortic stenosis and have diastolic dysfunction will receive the CORolla™ TAA device.

Primary Outcome Measures

Name	Time	Method
Cardiovasculare related SAEs	12 month post surgery	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.

Secondary Outcome Measures

Name	Time	Method
feasibility	up to 36 month post surgery	Change in Quality of Life (QoL): Minnesota Living with Heart Failure.
Feasibility	up to 36 month post surgery	Changes in cardiac medical therapy including daily diuretic dose

Trial Locations

Locations (2)

Multimedica; 🇮🇹 Milan, Italy

Spedali Civili - Brescia Hospital; 🇮🇹 Brescia, Italy