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Aortic StenosisCTRSNCT02629328

CardioCel Tri-leaflet Repair Study

A study testing CardioCel in people with Aortic Stenosis and Aortic Insufficiency, run by Anteris Technologies Ltd. at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will quantify the safety and efficacy of the CardioCel implant in tri-leaflet repair. 80 patients in up to 7 sites in Europe and the US will all be treated with the CardioCel implant. Read more about this study

Who is it for?
Ages Up to 85 years
Conditions the study is for
Aortic Stenosis, Aortic Insufficiency
What is being tested?
CardioCel
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteBelgium
Study dates
Sep 2015to 19 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 85 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • The subject's annular measurements are ≥ 19 mm to < 27mm as confirmed on pre-op echo and inter commissure distance equal to or bigger than 19mm as confirmed intraoperatively.
  • The subject is suitable for a tri-leaflet repair.
  • The subject has documented moderate-to-severe AS and/or AI.
  • The subject is willing and able to comply with specified follow-up evaluations, including trans oesophageal echocardiography (TEE) if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve. The subject has reviewed and signed the written informed consent form.
  • The subject upon final intraoperative assessment has intracardiac anatomy suitable for tri-leaflet repair using CardioCel.

Who cannot join

  • Greater than 85 years of age at the time of consent.
  • The subject's annular measurements < 19 mm or > 27mm.
  • All patients will be excluded who require emergent surgery (within 24 hours of a presentation to an emergency department) for any reason.
  • The subject will be excluded with pre-existing valve prosthesis in the aortic position.
  • Patients requiring repair of other cardiac valves will be excluded.
  • The subject has active endocarditis.
Show all 20Show fewer
  • Heavily calcified aortic roots or "porcelain aortas" (as evidenced on cardiac echo).
  • Leukopenia with a WBC of less than 3000 cells per microliter.
  • Acute anaemia with a haemoglobin less than 8 g/dL.
  • Platelet count less than 150.000 platelets/microliter.
  • History of a defined bleeding diathesis or coagulopathy or the subject refuses blood transfusions.
  • Active infection requiring antibiotic therapy (if temporary illness, subjects may enrol 2-4 weeks after discontinuation of antibiotics).
  • Subjects in whom trans oesophageal echocardiography (TEE) is contraindicated.
  • Low Ejection Fraction (EF) < 35%.
  • Life expectancy < 1 year, or severe comorbidities, such as cancer, dialysis, or severe COPD at the investigator's discretion
  • The subject is an illicit drug user, alcohol abuser, prisoner, institutionalised, or is unable to give informed consent.
  • The subject is pregnant or lactating (non-pregnancy to be confirmed by pregnancy test for all child bearing potential females prior to enrolment).
  • Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).
  • Myocardial Infarction (MI) within one month of trial inclusion
  • Upon intraoperative assessment of the intracardiac anatomy the patient is not suitable for tri-leaflet repair using CardioCel.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Universtiy Hospital Leuven

    Leuven, 3000

Other trials in Belgium

About this study

Official title: CardioCel Tri-leaflet Repair Study; a Prospective, Non-randomised, Single Arm, Multi-centre Clinical Investigation

This study will quantify the safety and efficacy of the CardioCel implant in tri-leaflet repair. 80 patients in up to 7 sites in Europe and the US will all be treated with the CardioCel implant.

Read the detailed description

The purpose of this study is to evaluate the safety and efficacy of the CardioCel for the repair of aortic valve stenosis and/or insufficiency. CardioCel is a cardiovascular patch manufactured with the so called ADAPT® technology. The ADAPT technology uses bovine spongiform encephalopathy-free pericardium which is processed in several ways to make it biocompatible with human tissue. CardioCel should provide an off the shelf material solution for tri-leaflet repair surgery due to its functional attributes, low propensity for post implant calcification, and overall biocompatibility. As a result adverse events and complications associated with the autologous pericardium repair surgery are mitigated.

In this study patients suffering from moderate-to-severe aortic stenosis and/or aortic insufficiency will be included.

In this study 80 patients will be enrolled in up to 7 centers in Europe and the US. The expected study duration is 36 months; 12 months of recruitment and 24 months follow-up.

CardioCel is US FDA cleared for the repair of cardiac and vascular defects, including intra-cardiac defects; septal defects, valve and annulus repair, great vessel reconstruction, peripheral vascular reconstruction, suture line buttressing and pericardial closure.

Being tested
CardioCel
Keywords
CardioCel, FDA cleared, Tri-leaflet repair, Aortic valves
Medical subject headings
Aortic Valve Stenosis, Aortic Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CardioCelDevice

    Treatment with CardioCel implant

Study groups in NCT02629328
Study groupRoleWhat they receive
CardioCelOtherTreatment with CardioCel implant
Receives: Device: CardioCel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-hospital survival (defined as percentage of patients alive and discharged from the index operation - presented as the inverse, or standard surgical operative mortality)

    Measured: Pre-operative to 14 days post-operative

  2. Changes in mean aortic valve gradients from preoperative (baseline screening) to 6 months post-valve repair assessed by transthoracic or transesophageal echocardiography

    Measured: Pre-operative to 6 months post-valve repair

  3. Mean transaortic valve gradient, measured using echocardiography, postoperatively, and at 6 and 12 months after valve repair.

    Measured: Up to 12 months post-valve repair

  4. Aortic regurgitation grade (assessed on a 0-4 scale), measured using echocardiography, postoperatively, and at 6 and 12 months after valve repair.

    Measured: Up to 12 months post-valve repair

Secondary outcomes (6)

  1. Changes from preoperative to 6-months postoperative in linear left ventricular (LV) diastolic and systolic dimensions measured from parasternal long axis views by echocardiography.

    Measured: Pre-operative to 6 months post-valve repair

  2. Changes from preoperative to 6-months postoperative in left ventricular volume measured by the Simpson's Biplane method using echocardiography.

    Measured: Pre-operative to 6 months post-valve repair

  3. Changes from preoperative to 6-months postoperative in LV mass (if calculated), using the area-length method, assessed by echocardiography.

    Measured: Pre-operative to 6 months post-valve repair

  4. Changes in symptomatic status (NYHA CHF Classification) from preoperative to 6 months after aortic valve repair.

    Measured: Pre-operative to 6 months post-valve repair

  5. Changes in patient reported outcomes (EQ-5D) from baseline to 26 week postoperative

    Measured: Baseline to 26 weeks post-valve repair

  6. Implant procedure success (evaluated through post-procedure hospital discharge) measured by the incidence of pre-defined adverse events:

    Measured: From study enrolment to 24 months post-valve repair

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2015 (estimated)
  2. Study startSep 2015
  3. Primary completion5 Jul 2017
  4. Study completion19 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02629328
Sponsor's protocol ID
CTRS-2015-01
Other IDs
EUDAMED
Acronym
CTRS
Status last verified
Jan 2019
First submitted
16 Nov 2015
Last updated
29 Jan 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing CardioCel in people with Aortic Stenosis and Aortic Insufficiency, run by Anteris Technologies Ltd. at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-hospital survival (defined as percentage of patients alive and discharged from the index operation - presented as the inverse, or standard surgical operative mortality) (time frame: Pre-operative to 14 days post-operative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02629328.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019; AzTrials last refreshed its copy on 27 Oct 2026.

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