CardioCel Tri-leaflet Repair Study

NCT02629328 | Completed DMC

• 2 other identifiers: CTRS-2015-01EUDAMED
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis; Aortic Insufficiency

Keywords

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

Outcome Measures

Primary Outcomes (4)

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

  Pre-operative to 14 days post-operative

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

  Pre-operative to 6 months post-valve repair

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

  Up to 12 months post-valve repair

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

  Up to 12 months post-valve repair

Secondary Outcomes (6)

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

  Pre-operative to 6 months post-valve repair

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

  Pre-operative to 6 months post-valve repair

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

  Pre-operative to 6 months post-valve repair

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

  Pre-operative to 6 months post-valve repair

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

  Baseline to 26 weeks post-valve repair

Study Arms (1)

CardioCel

OTHER

Treatment with CardioCel implant

Device: CardioCel

Interventions

CardioCel DEVICE

Treatment with CardioCel implant

CardioCel

Eligibility Criteria

• Age: Up to 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Anteris Technologies Ltd.: lead

Study Sites (1)

Universtiy Hospital Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Dominico Mazzitelli, M.D.

  German Heart Centre of the Technical University

  PRINCIPAL INVESTIGATOR

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: November 16, 2015
• First Posted: December 14, 2015
• Study Start: September 1, 2015
• Primary Completion: July 5, 2017
• Study Completion: November 19, 2018
• Last Updated: January 29, 2019

Record last verified: 2019-01

Locations

BE (1)