NCT01956526

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".

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

2.1 years

First QC Date

August 12, 2013

Last Update Submit

October 7, 2013

Conditions

Diastolic Heart Failure NYHA Class III-IVDiastolic Dysfunction Secondary to Aortic Stenosis

Keywords

Heart Failure with Preserved Ejection Fraction (HFpEF)Diastolic Heart Failure (DHF)Diastolic Dysfunction (DD)

Outcome Measures

Primary Outcomes (1)

  • Cardiovasculare related SAEs

    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.

    12 month post surgery

Secondary Outcomes (7)

  • feasibility

    up to 36 month post surgery

  • Feasibility

    up to 36 month post surgery

  • Feasibility

    up to 36 month post surgery

  • Feasibility

    Up to 36 month post surgery

  • Feasibility

    up to 36 month post surgery

  • +2 more secondary outcomes

Other Outcomes (1)

  • Procedural success

    intra procedural

Study Arms (3)

CORolla™ TAA Stand Alone

EXPERIMENTAL

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;

Device: CORolla™ TAA device

AVR and CORolla™ TAA Add On group

EXPERIMENTAL

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

Device: CORolla™ TAA device

AVR and CORolla ADD On - Control

NO INTERVENTION

patients who require only the aortic valve replacement (AVR) due to aortic stenosis and have diastolic dysfunction.

Interventions

CORolla™ TAA deviceDEVICE
AVR and CORolla™ TAA Add On groupCORolla™ TAA Stand Alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +1 more criteria

You may not qualify if:

  • 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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Spedali Civili - Brescia Hospital

Brescia, 25123, Italy

RECRUITING

Multimedica

Milan, 20099, Italy

NOT YET RECRUITING

Related Publications (2)

  • Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Stromberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K; ESC Committee for Practice Guidelines (CPG). ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J. 2008 Oct;29(19):2388-442. doi: 10.1093/eurheartj/ehn309. Epub 2008 Sep 17. No abstract available.

    PMID: 18799522BACKGROUND

  • Paulus WJ, Tschope C, Sanderson JE, Rusconi C, Flachskampf FA, Rademakers FE, Marino P, Smiseth OA, De Keulenaer G, Leite-Moreira AF, Borbely A, Edes I, Handoko ML, Heymans S, Pezzali N, Pieske B, Dickstein K, Fraser AG, Brutsaert DL. How to diagnose diastolic heart failure: a consensus statement on the diagnosis of heart failure with normal left ventricular ejection fraction by the Heart Failure and Echocardiography Associations of the European Society of Cardiology. Eur Heart J. 2007 Oct;28(20):2539-50. doi: 10.1093/eurheartj/ehm037. Epub 2007 Apr 11.

    PMID: 17428822BACKGROUND

MeSH Terms

Conditions

Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Central Study Contacts

Lea Lak, M.D.

CONTACT

+972 9 9554500lea@corassist.com

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2013

First Posted

October 8, 2013

Study Start

August 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2017

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

IT(2)