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Trial registered on ANZCTR


Registration number
ACTRN12619001365156p
Ethics application status
Submitted, not yet approved
Date submitted
27/08/2019
Date registered
4/10/2019
Date last updated
4/10/2019
Date data sharing statement initially provided
4/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to evaluate the safety and effectiveness of the Navigate Cardiac Structures, Incorporated (NCSI) replacement heart valve and delivery system in high risk cardiac surgical patients with regurgitant (leaky) tricuspid valves.
Scientific title
GATE™ Atrioventricular Valved StenT for ReplacemEnt in Tricuspid Regurgitation: Feasibility Trial
Secondary ID [1] 299114 0
None
Universal Trial Number (UTN)
U1111-1238-5455
Trial acronym
GATER 01-19
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Functional Tricuspid Valve (TV) Regurgitation 314165 0
Condition category
Condition code
Cardiovascular 312534 312534 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once an incision in your chest or neck has been made, the valve delivery system is used to guide the replacement valve into your heart. When the valve has been guided to the correct location, it is released from the delivery system. The new valve serves to replace your diseased valve by opening to allow forward flow and closing to prevent leakage.

The duration of the procedure from access to insertion of the replacement of the heart valve is approximately 2 hours, depending of the level of difficulty. The entire procedure is performed while you are under sedation, by a cardiologist supported by a cardiac team.

During the procedure, various imaging techniques, e.g., x-ray, doppler echo cardiography, etc., will be used to assure that the replacement heart valve is delivered to its intended implantation site. You will be monitored by a professional team of doctors and nurses in the hospital after the procedure and thereafter during scheduled follow-up visits with your physician.

Physical items used include a delivery system and replacement heart valve. Polymers are mainly used to manufacture the delivery system, and the replacement heart valve is mainly manufactured from specially treated tissue that has been securely attached to a self-expanding metal frame. The delivery system, which includes a small tube similar in diameter to the size of a finger, is used to guide and deliver the replacement valve to the heart.
Intervention code [1] 315381 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321177 0
Tricuspid Valve function will be assessed by echocardiography. A grading system of zero to 4 will be used to evaluate the performance of the replaced valve, with a goal of reducing tricuspid valve regurgitation.
Timepoint [1] 321177 0
30 Days after receiving the replacement heart valve,
Primary outcome [2] 321178 0
The primary patient related effectiveness outcome is an evaluation of the improvement in the 6 minute walk test. which will reflect the impact of the valve replacement on the patients ability to increase distance walked.
Timepoint [2] 321178 0
6-months after receiving the replacement heart valve.
Primary outcome [3] 321179 0
The primary safety outcome will be a composite of the below Major Adverse Events (MAE) which will be collected from the medical records.

All cause mortality
Myocardial Infarction as assessed by elevated cardiac biomarkers (CK-MB) and ECG changes
Acute kidney injury requiring dialysis
Valve related dysfunction requiring repeat procedures including surgical valve replacement.
Timepoint [3] 321179 0
30 Days after receiving the replacement heart valve.
Secondary outcome [1] 374201 0
Acute Procedural Success as determined by a composite of the reduction in tricuspid regurgitation as measured by echocardiography in association with a live patient at the end of the procedure and all delivery system material successfully removed will be collected from medical records.
Timepoint [1] 374201 0
During and immediately post procedure.
Secondary outcome [2] 374202 0
Radiation exposure is monitored by the amount of x-ray used during the procedure and the recorded fluoroscopy time and intensity. Information will be collected from the medical records
Timepoint [2] 374202 0
During the procedure.
Secondary outcome [3] 374203 0
Tricuspid Valve function will be assessed by echocardiography.
Timepoint [3] 374203 0
At 6 months 1 year, 2 years and 3 years post replacement heart valve
Secondary outcome [4] 375252 0
Clinical Effectiveness will be evaluated by a composite of the below Major Adverse Events (MAE) which will be collected from the medical records.
• All Cause Mortality
• Requiring hospitalizations for valve related symptoms or worsening congestive heart failure
• Valve related dysfunction
• Requirement for Tricuspid valve surgery
Timepoint [4] 375252 0
At 6 months 1 year, 2 years and 3 years post replacement heart valve
Secondary outcome [5] 375253 0
Change in diuretic dosage as reported in the medical records
Timepoint [5] 375253 0
At 30 days, 6 months 1 year, 2 years and 3 years post replacement heart valve.
Secondary outcome [6] 375254 0
Permanent Pacemaker Implantation as reported in the medical records.
Timepoint [6] 375254 0
At 30 days after the procedure, then at 6 months 1 year, 2 years and 3 years post replacement heart valve,

Eligibility
Key inclusion criteria
- Patient must be 18 years or older at time of consent and must not be a member of a vulnerable population
- Patient must provide written informed consent prior to any trial-related procedure.
- Patient must agree not to participate in any other clinical trial for a period of one year following the index procedure and be willing to participate in the follow up visits per study outline.
- NYHA Functional Class II (conditional), III or IV (ambulatory)
- The center's Cardiac Team (Interventional Cardiologist. Cardiac Surgeon and Echo Cardiologist) concur that the percutaneous GATE™ implantation is appropriate for this patient due to the high surgical risk of cardiopulmonary bypass.

Echocardiographic Inclusion Criteria:
- Moderate or greater than or equal to 3+ TR determined by the assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TOE) confirmed by the Image Core Lab
- The repeat TTE and TOE must define the anatomy of the TV to be suitable for implantation of the GATE™.
- Pacemaker or Implantable Cardioverter Defibrillator (ICD) leads that are not immobile and not fixed to the leaflets.
- Left Ventricular Ejection Fraction (LVEF) of greater than or equal to 35%
- Right Heart Catheterization: The patient's pulmonary vasculature resistance is less than 5 Woods units
- Six Minute Walk Test at Baseline - The patient must walk at least 150 meters
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient is currently participating in another clinical trial that has not yet completed its endpoint
- Severe uncontrolled hypertension Systolic Blood Pressure (SBP) > 180 mmHg and/or Diastolic Blood Pressure (DBP) > 110 mmHg
- Systolic Pulmonary Artery Pressure >60 mm (determined by right heart cath)
- Prior surgical repair or replacement of the tricuspid valve with a bioprosthesis.
- Atrial septal defect closure with a device or ventricular septal defect (VSD) repair.
- Intracardiac mass, thrombus, or other device other than pacing lead
- Mitral Regurgitation (MR) moderate-to-severe or greater than or equal to 3+ Pacemaker or ICD leads that would prevent appropriate placement of the GATE™ atrioventricular valved stent are not mobile and fixed to the leaflet
- Active endocarditis (within the Last 90 days). If the patient has a history of endocarditis within one year of the planned procedure, there must be evidence of negative blood cultures,
- Myocardial Infarction (MI) or known unstable angina within 30 days prior to procedure
- Percutaneous coronary intervention within the last 30 days prior to procedure
- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following the index procedure, Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
- Hemodynamic instability defined as systolic pressure <90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device
- Cerebrovascular Accident (CVA) within prior 6 months prior to enrollment
- Chronic Dialysis
- Bleeding diatheses or hypercoagulable state
- Active peptic ulcer or active gastrointestinal (Gl) bleeding
- Contraindication to anticoagulant therapy
- Life expectancy of less than 12 months due to non-cardiac conditions
- Carcinoid disease and the other primary etiologies of TR to include Ebstein's anomaly, endomyocardial fibrosis, rheumatic heart disease with both stenosis and regurgitation which implies significant subvalvular disease and thickened leaflets not ideal for landing zone
- Patient must not be on supplemental oxygen therapy to be a candidate for the study.
- Patient is not on dual antiplatelet therapy such that the post op course would require "triple anticoagulant therapy".
- Right heart Catheterization: Pulmonary artery resistance of 5 Woods units or more

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A minimum of 100 patients will be prospectively enrolled in this single arm phase study in up to 14 centers located in Australia, New Zealand, Canada, Europe and the United States. The statistical action plan is being prepared.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/10/2019
Actual
Date of last participant enrolment
Anticipated
9/10/2020
Actual
Date of last data collection
Anticipated
9/10/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 14618 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 14619 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 14620 0
St Vincents & Mercy Private Hospital - Mercy campus - East Melbourne
Recruitment hospital [4] 14621 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 27642 0
3168 - Clayton
Recruitment postcode(s) [2] 27643 0
2050 - Camperdown
Recruitment postcode(s) [3] 27644 0
3002 - East Melbourne
Recruitment postcode(s) [4] 27645 0
2010 - Darlinghurst
Recruitment outside Australia
Country [1] 21808 0
New Zealand
State/province [1] 21808 0
Waikato
Country [2] 21813 0
Canada
State/province [2] 21813 0
Quebec

Funding & Sponsors
Funding source category [1] 303652 0
Commercial sector/Industry
Name [1] 303652 0
NaviGate Cardiac Structures, Inc.
Country [1] 303652 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
NaviGate Cardiac Structures. Inc.
Address
20412 James Bay Circle
Lake Forest
California USA
92630
Country
United States of America
Secondary sponsor category [1] 303740 0
None
Name [1] 303740 0
Address [1] 303740 0
Country [1] 303740 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304174 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 304174 0
Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Ethics committee country [1] 304174 0
Australia
Date submitted for ethics approval [1] 304174 0
08/10/2019
Approval date [1] 304174 0
Ethics approval number [1] 304174 0
Ethics committee name [2] 304175 0
Health and Disability Ethics Committee
Ethics committee address [2] 304175 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [2] 304175 0
New Zealand
Date submitted for ethics approval [2] 304175 0
17/09/2019
Approval date [2] 304175 0
Ethics approval number [2] 304175 0

Summary
Brief summary
While traditional surgical procedures for heart valve replacement generally require a large incision in the middle of the chest and use of a heart-lung machine, the GATE tricuspid valve is delivered through a comparatively small incision in the chest or neck in a beating heart. This approach can be referred to as being “minimally invasive.” The procedure includes use of a catheter delivery system, through which the replacement valve is delivered to the heart.

By replacing the diseased native valve, the purpose of the study is to demonstrate that the GATE system provides a safe and effective means of restoring valve function and improving quality of life for patients at high risk for traditional cardiac surgery.

The study hypothesizes that replacing the diseased tricuspid valve in a minimally invasive manner will restore valve function, minimize regurgitation (leaking) and lead to improved quality of life.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96050 0
Prof Josep Rodes Cabau
Address 96050 0
Laval University, 2725 Chemin Sainte-Foy, Quebec G1V 4G5, Canada
Country 96050 0
Canada
Phone 96050 0
+1 418 656 8711
Fax 96050 0
+1 418 656-4672
Email 96050 0
[email protected]
Contact person for public queries
Name 96051 0
Thomas Humphrey
Address 96051 0
NaviGate Cardiac Structures, Inc., 20412 James Bay Circle, Lake Forest, California 92630
Country 96051 0
United States of America
Phone 96051 0
+1 949 238 6274
Fax 96051 0
+1 949 238 6274
Email 96051 0
[email protected]
Contact person for scientific queries
Name 96052 0
Kalathi Thyagarajan
Address 96052 0
NaviGate Cardiac Structures, Inc., 20412 James Bay Circle, Lake Forest, California 92630
Country 96052 0
United States of America
Phone 96052 0
+1 949 381 5765
Fax 96052 0
+1 949 3815765
Email 96052 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidentiality of all participant data will be maintained in accordance with Local and/or regional requirements.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.