NCT02499601

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.

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
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 7, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

October 8, 2020

Status Verified

June 1, 2020

Enrollment Period

6 years

First QC Date

July 7, 2015

Last Update Submit

October 7, 2020

Conditions

Diastolic Heart FailureDiastolic Dysfunction

Keywords

Heart Failure with Preserved Ejection Fraction (HFpEF)Heart Failure (HF)New York Heart Association functional Class (NYHA f. Cl)

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (13)

  • Rate of HF death and re-hospitalization due to HF (including IV diuretic)

    6 months

  • Rate of HF death and re-hospitalization due to HF (including IV diuretic)

    12 months

  • Rate, type and severity of procedure related and device-related events

    30 days

  • Rate of device related Major Adverse Cardiac and Neurological Events (MACNE)

    up to 6 months

  • Change in Quality of Life (QoL) Questionnaire

    up to 24 months

  • +8 more secondary outcomes

Study Arms (1)

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

Interventions

CORolla™ TAA deviceDEVICE
CORolla™ 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 ejection fraction
  • NYHA F. Class III or IV or documented history of at least two heart failure hospitalization in the past year prior to enrollment.
  • No contraindication for anticoagulation and antiplatelet treatment.
  • Optimal medical cardiovascular pharmacotherapy with stable doses for at least 4 weeks (not including diuretics)
  • Pulmonary Wedge pressure \> 15 mmHg documented by right heart catheterization at enrollment.
  • Patient understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
  • Patient is able and willing to adhere to the required follow-up visits and testing
  • Minimal endocardial height from Apex to Mitral Annulus \> 60mm at end systole
  • Echocardiographic criteria:
  • Left ventricular ejection fraction≥50%
  • HFpEF diagnosis according to ESC 2016 guidelines
  • No evidence of intra-cardiac thrombus
  • Cardiovascular disease:
  • +26 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RAMBAM - Health Care Campus

Haifa, 3109601, Israel

RECRUITING

Related Links

MeSH Terms

Conditions

Heart Failure, DiastolicHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Ruti Hoefler, B.Sc

CONTACT

ruti@corassist.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2015

First Posted

July 16, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2021

Study Completion

September 1, 2024

Last Updated

October 8, 2020

Record last verified: 2020-06

Locations

IL(1)