Clinical trial NCT04029363: Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk
Official title: Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Lead sponsor: HighLife SAS
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2019-07-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.


Eligibility criteria: Inclusion Criteria:

* 1. Age ≥ 18 years 2. Moderate-severe or severe mitral regurgitation (≥ 3+) 3. Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV 4. Patient is under guideline directed medical therapy, as reviewed and confirmed by the local multidisciplinary Heart Team, for at least one month 5. Patient is high-risk for open-heart surgery based on the assessment of the multidisciplinary Heart Team using standard scoring systems and consideration of co-morbidities, frailty, and disability 6. Patient meets the anatomical criteria for HighLife valve 7. Patient is willing to participate in the study and provides signed informed consent

Exclusion Criteria:

1. Any stroke/TIA within 30 days
2. Severe symptomatic carotid stenosis (\> 70% by non-invasive imaging)
3. Active infections requiring antibiotic therapy
4. Active ulcer or gastro-intestinal bleeding in the past 3 months
5. History of bleeding diathesis, coagulopathy or refusal of future blood transfusion
6. Patients in whom TEE is not feasible
7. Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months.
8. Patient is unable to comply with the follow-up schedule and assessments
9. Participation in another clinical investigation at the time of inclusion
10. Patient has known allergies to the device components or contrast medium
11. Patient cannot tolerate anticoagulation or antiplatelet therapy
12. Patients with a life expectancy of less than 12 months due to non-cardiac conditions
13. Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months

    -

Primary outcomes:
measure: Device Safety
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital - Sydney
state: New South Wales
city: Newcastle
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Auchenflower
country: Australia
facility: The Wesley Hospital
state: Queensland
city: Adelaide
country: Australia
facility: St. Andrew's Hospital
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
city: Heidelberg
country: Australia
facility: Warringal Hospital
city: Melbourne
country: Australia
facility: The Alfred Hospital
city: Newcastle
country: Australia
facility: John Hunter Hospital
city: Perth
country: Australia
facility: Mount Hospital
city: Sydney
country: Australia
facility: North Shore Private Hospital
city: Antwerp
country: Belgium
facility: ZNA Middelheim
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Leuven
country: Belgium
facility: UZ Leuven
city: Lille
country: France
facility: CHU Lille
city: Lyon
country: France
facility: Medipole Lyon-Villeurbanne
city: Massy
country: France
facility: Hopital Prive - Jacques Cartier
city: Nantes
country: France
facility: Centre Hospitalo-Universitaire de Nantes
city: Paris
country: France
facility: European Hospital George Pompidou
city: Pessac
country: France
facility: CHU Bordeaux
city: Rennes
country: France
facility: CHU de Rennes
city: St. Denis
country: France
facility: Centr Cardiologiqque du Nord
city: Strasbourg
country: France
facility: CHRU Strasbourg
city: Toulouse
country: France
facility: Clinque Pasteur
city: Toulouse
country: France
facility: Rangueil University Hospital
city: Toulouse
country: France
facility: Rangueil University Hospital
city: Bad Krozingen
country: Germany
facility: University Heart Center Freiburg - Bad Krozingen
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn
city: Dresden
country: Germany
facility: Heart Center, University Hospital Dresden
city: Hamburg
country: Germany
facility: Universitatsklink Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Mediinisches Versorgungszentrum
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
city: Leipzig
country: Germany
facility: Herzentrum Leipzig
city: Munich
country: Germany
facility: Deutsches Herzzentrum Munchen
city: Rostock
country: Germany
facility: University Medicine Dept of Cardiology
city: Ulm
country: Germany
facility: University Hospital Ulm
city: Gdańsk
country: Poland
facility: Medical University of Gdansk
city: Katowice
country: Poland
facility: Medical University of Silesia Hospital
city: Poznan
country: Poland
facility: University Hospital of Lord's Transfiguration
city: Warsaw
country: Poland
facility: Medical University of Warsaw
city: Warsaw
country: Poland
facility: Institute of Cardiology
city: Singapore
country: Singapore
facility: National Heart Center Singapore
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: London
country: United Kingdom
facility: Guy's and St. Thomas' NHS Foundation Trust - St. Thomas Hospital
city: London
country: United Kingdom
facility: Barts Heart Center
city: Oxford
country: United Kingdom
facility: John Radcliffe
Study officials:
References: