Back to results

CardioCel Tri-leaflet Repair Study (CTRS)

Primary Purpose

Aortic Stenosis, Aortic Insufficiency

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

CardioCel

About this trial

This is an interventional treatment trial for Aortic Stenosis focused on measuring CardioCel, FDA cleared, Tri-leaflet repair, Aortic valves

Eligibility Criteria

undefined - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Sites / Locations

Universtiy Hospital Leuven

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CardioCel

Arm Description

Treatment with CardioCel implant

Outcomes

Primary Outcome Measures

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

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

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

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

Secondary Outcome Measures

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

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

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

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

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

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

Full Information

NCT ID

NCT02629328

First Posted

November 16, 2015

Last Updated

January 28, 2019

Sponsor

Anteris Technologies Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02629328

Brief Title

CardioCel Tri-leaflet Repair Study

Acronym

CTRS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

September 2015 (undefined)

Primary Completion Date

July 5, 2017 (Actual)

Study Completion Date

November 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Anteris Technologies Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Stenosis, Aortic Insufficiency

Keywords

CardioCel, FDA cleared, Tri-leaflet repair, Aortic valves

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CardioCel

Arm Type

Other

Arm Description

Treatment with CardioCel implant

Intervention Type

Device

Intervention Name(s)

CardioCel

Intervention Description

Treatment with CardioCel implant

Primary Outcome Measure Information:

Title

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

Title

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

Time Frame

Pre-operative to 6 months post-valve repair

Title

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

Time Frame

Up to 12 months post-valve repair

Title

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

Time Frame

Up to 12 months post-valve repair

Secondary Outcome Measure Information:

Title

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

Time Frame

Pre-operative to 6 months post-valve repair

Title

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

Time Frame

Pre-operative to 6 months post-valve repair

Title

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

Time Frame

Pre-operative to 6 months post-valve repair

Title

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

Time Frame

Pre-operative to 6 months post-valve repair

Title

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

Time Frame

Baseline to 26 weeks post-valve repair

Title

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

Time Frame

From study enrolment to 24 months post-valve repair

10. Eligibility

Sex

All

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dominico Mazzitelli, M.D.

Organizational Affiliation

German Heart Centre of the Technical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universtiy Hospital Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

CardioCel Tri-leaflet Repair Study

We'll reach out to this number within 24 hrs