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Investigation of a Transcatheter Tricuspid Valved Stent Graft in Patients With Carcinoid Heart Disease (TRICAR)

Primary Purpose

Tricuspid Regurgitation, Tricuspid Valve Disease, Carcinoid Syndrome

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Transcatheter Tricuspid Valved Stent Graft
Sponsored by
Queen Mary University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tricuspid Regurgitation focused on measuring Heart, Valve, Implantation, Transcatheter, Carcinoid

Eligibility Criteria

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

General Inclusion Criteria

  • Male or female age ≥18 yrs
  • Carcinoid Heart Disease
  • NYHA Class II - IV
  • Severe symptomatic tricuspid regurgitation
  • Inoperable due to active tumour process or patient declines an operative intervention
  • Patient willing and able to consent and comply with specified study evaluations
  • Adequate understanding of written or spoken English (to complete validated questionnaires)

General Exclusion Criteria

  • Previous tricuspid valve repair or replacement
  • Permanent vena cava filter
  • Mega atrium
  • Tricuspid valve stenosis
  • Thrombosis of lower venous system
  • Severe uncontrolled hypertension (Systolic BP ≥ 180 mmHg and/or Diastolic BP ≥ 110 mm Hg)
  • Active endocarditis
  • Subject is on chronic dialysis
  • Bleeding disorders or hypercoaguable state
  • Hemodynamic instability or on IV inotropes
  • Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically eg contrast
  • Contraindication to anticoagulants or antiplatelet medication
  • Known allergy to Nitinol (Titanium or Nickel) alloy, gold or porcine tissue
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Any Percutaneous Coronary Intervention (PCI) or transcatheter valvular intervention within 30 days prior to the index procedure or planned 3 months post the index procedure
  • Myocardial Infarction (MI) or known unstable angina within the 30 days prior to the index procedure
  • Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure
  • Contraindication to long-term anticoagulation
  • Life expectancy according to tumour development is less than 12 months
  • Impaired judgment and/or is undergoing emergency treatment

Sites / Locations

  • Barts Health NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcatheter Tricuspid Valved Stent Graft intervention

Arm Description

Participants who have carcinoid heart disease with severe symptomatic tricuspid regurgitation and with a significant backflow in the caval and hepatic veins will be treated with the implantation of the Transcatheter Tricuspid Valved Stent Graft

Outcomes

Primary Outcome Measures

The number of patients with successful implantation of the TRICENTO bioprosthesis
with a 35% change (reduction) in the V wave pressure in the Inferior Vena Cava (IVC)

Secondary Outcome Measures

To assess the safety of the Tricuspid Valved Stent Graft implantation procedure in patients with carcinoid heart disease with severe symptomatic TR and significant systolic backflow in the hepatic and caval veins, and who are not suitable for surgery.
The number of procedural complications (re-interventions related to the device or access procedure, major vascular or bleeding complication (VARC), cardiac death during hospital stay (max 7 days) Rate of death all causes
•To evaluate the reduced symptom burden according to New York Heart Association (NYHA) score
•NYHA assessment
To evaluate the change in peripheral oedema experienced by patients
measure of ankle circumference (cm) assessment of oedema scored as: none = 0, ankle = 1, shin = 2, thigh = 3, anasarca = 4
To evaluate the change in of number of admissions to hospital for heart failure
Count of number of hospital admissions for heart failure
To evaluate the change in patient reported quality of life (EuroQol- 5 Dimension - EQ5D)
Measure EQ5D scores for all patients
To evaluate the change in patient reported quality of life (Kansas City Cardiomyopathy Questionnaire (KCCQ))
Measure Kansas City Cardiomyopathy Questionnaire scores for all patients
To evaluate the change in patient reported quality of life (Minnesota Living With Heart Failure - MLFHQ)
Measure MLFHQ scores for all patients

Full Information

First Posted
September 16, 2021
Last Updated
January 12, 2023
Sponsor
Queen Mary University of London
Collaborators
Royal Free Hospital NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05064514
Brief Title
Investigation of a Transcatheter Tricuspid Valved Stent Graft in Patients With Carcinoid Heart Disease
Acronym
TRICAR
Official Title
Single Centre, Prospective, Single Arm Open Label Series of a Transcatheter Tricuspid Valved Stent Graft System for the Reduction of Tricuspid Regurgitation and Improved Patient Reported Outcomes in Patients With Carcinoid Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Mary University of London
Collaborators
Royal Free Hospital NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this investigation is to see if the TRICENTO Valved Stent Graft implant reduces tricuspid regurgitation (TR) and improves the symptoms and quality of life in 15 participants with carcinoid heart disease, and who are not able to have a new valve via a surgical procedure.
Detailed Description
After being informed about the study and the potential risks and benefits, participants who provide written consent will be screened to make sure they fulfil the study entry requirements. This will involve a detailed medical history, a CT and an echo scan. Once it is agreed that the participant is suitable for the study, a custom-made TRICENTO valve is prescribed and made. Participants need to be admitted to hospital for the TRICENTO device to be implanted. Before the device is implanted the participant will have further tests and measurements completed eg ECG, a Cardiac MRI, physical measurements such as height, weight and blood pressure, blood tests, questionnaires and measuring how far they can walk in 6 minutes. The device is implanted in a cath lab procedure which should take about 30-60 minutes in total. Participants should be discharged from hospital about 2-3 days later after recovery and further echocardiogram, blood tests and questionnaires. Follow up visits are at 1 month and 6 months after the procedure. The following measurements such as an ECG, echocardiogram, and physical measurements (height, weight and blood pressure), some blood tests, questionnaires and measuring how far they can walk in 6 minutes will be repeated at 1 month and at 6 months after the procedure. A cardiac MRI will also be repeated at 6 months after the procedure. All these tests are to measure whether the TRICENTO valve improves the participant's heart function, symptoms and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Regurgitation, Tricuspid Valve Disease, Carcinoid Syndrome, Carcinoid Heart Disease
Keywords
Heart, Valve, Implantation, Transcatheter, Carcinoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-arm, prospective single-centre interventional study to test safety and efficacy of the Tricento Transcatheter Tricuspid Valved Stent Graft
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcatheter Tricuspid Valved Stent Graft intervention
Arm Type
Experimental
Arm Description
Participants who have carcinoid heart disease with severe symptomatic tricuspid regurgitation and with a significant backflow in the caval and hepatic veins will be treated with the implantation of the Transcatheter Tricuspid Valved Stent Graft
Intervention Type
Device
Intervention Name(s)
Transcatheter Tricuspid Valved Stent Graft
Other Intervention Name(s)
TRICENTO
Intervention Description
All participants meeting the inclusion and none of the exclusion criteria will be enrolled. A custom-made Transcatheter Tricuspid Valved Stent Graft based on CT to define anatomic dimensions will be made. The system consists of a custom-made valved stent graft delivery system, a custom-made valved stent graft bioprosthesis and a loading system. The bioprosthesis is self-expanding and consists of a stent graft spanning from the inferior vena cava to the superior vena cava and a lateral bicuspid valve element made of thin porcine pericardial leaflets requiring a low closing pressure, and Nitinol support structures. The participants will undergo a minimally invasive, catheter-based procedure to implant the bioprosthesis which is delivered through a 24 French delivery system via transfemoral access. The device can be repositioned and is retrievable.
Primary Outcome Measure Information:
Title
The number of patients with successful implantation of the TRICENTO bioprosthesis
Description
with a 35% change (reduction) in the V wave pressure in the Inferior Vena Cava (IVC)
Time Frame
measured pre intervention and immediately after the intervention
Secondary Outcome Measure Information:
Title
To assess the safety of the Tricuspid Valved Stent Graft implantation procedure in patients with carcinoid heart disease with severe symptomatic TR and significant systolic backflow in the hepatic and caval veins, and who are not suitable for surgery.
Description
The number of procedural complications (re-interventions related to the device or access procedure, major vascular or bleeding complication (VARC), cardiac death during hospital stay (max 7 days) Rate of death all causes
Time Frame
At baseline, 1 month and 6 months
Title
•To evaluate the reduced symptom burden according to New York Heart Association (NYHA) score
Description
•NYHA assessment
Time Frame
At baseline, and post intervention at 1 month and 6 months
Title
To evaluate the change in peripheral oedema experienced by patients
Description
measure of ankle circumference (cm) assessment of oedema scored as: none = 0, ankle = 1, shin = 2, thigh = 3, anasarca = 4
Time Frame
At baseline, 1 month and 6 months
Title
To evaluate the change in of number of admissions to hospital for heart failure
Description
Count of number of hospital admissions for heart failure
Time Frame
6 months before procedure and 6 months post implantation.
Title
To evaluate the change in patient reported quality of life (EuroQol- 5 Dimension - EQ5D)
Description
Measure EQ5D scores for all patients
Time Frame
At baseline, and post intervention at 1 month and 6 months
Title
To evaluate the change in patient reported quality of life (Kansas City Cardiomyopathy Questionnaire (KCCQ))
Description
Measure Kansas City Cardiomyopathy Questionnaire scores for all patients
Time Frame
At baseline, and post intervention at 1 month and 6 months
Title
To evaluate the change in patient reported quality of life (Minnesota Living With Heart Failure - MLFHQ)
Description
Measure MLFHQ scores for all patients
Time Frame
At baseline, and post intervention at 1 month and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
General Inclusion Criteria Male or female age ≥18 yrs Carcinoid Heart Disease NYHA Class II - IV Severe symptomatic tricuspid regurgitation Inoperable due to active tumour process or patient declines an operative intervention Patient willing and able to consent and comply with specified study evaluations Adequate understanding of written or spoken English (to complete validated questionnaires) General Exclusion Criteria Previous tricuspid valve repair or replacement Permanent vena cava filter Mega atrium Tricuspid valve stenosis Thrombosis of lower venous system Severe uncontrolled hypertension (Systolic BP ≥ 180 mmHg and/or Diastolic BP ≥ 110 mm Hg) Active endocarditis Subject is on chronic dialysis Bleeding disorders or hypercoaguable state Hemodynamic instability or on IV inotropes Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically eg contrast Contraindication to anticoagulants or antiplatelet medication Known allergy to Nitinol (Titanium or Nickel) alloy, gold or porcine tissue Untreated clinically significant coronary artery disease requiring revascularization Any Percutaneous Coronary Intervention (PCI) or transcatheter valvular intervention within 30 days prior to the index procedure or planned 3 months post the index procedure Myocardial Infarction (MI) or known unstable angina within the 30 days prior to the index procedure Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure Contraindication to long-term anticoagulation Life expectancy according to tumour development is less than 12 months Impaired judgment and/or is undergoing emergency treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Baumbach
Organizational Affiliation
Queen Mary University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barts Health NHS Trust
City
London
State/Province
England
ZIP/Postal Code
E1 1BB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Investigation of a Transcatheter Tricuspid Valved Stent Graft in Patients With Carcinoid Heart Disease

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