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Study of Transcatheter Tricuspid Annular Repair (STTAR)

Primary Purpose

Tricuspid Regurgitation

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

MIA, Minimally Invasive Annuloplasty Device - Surgical

MIA, Minimally Invasive Annuloplasty Device - Percutaneous

About this trial

This is an interventional treatment trial for Tricuspid Regurgitation

Eligibility Criteria

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

Inclusion Criteria:

Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation (2-4)
Age≥18 and ≤85 years old
New York Heart Association (NYHA) Class II, III or ambulatory IV
Left ventricular ejection fraction (LVEF) ≥30%
Undergoing cardiac surgical procedure with the planned use of cardiopulmonary bypass (surgical arm only)
Functional tricuspid valve regurgitation pathology with a structurally normal valve; and tricuspid valve annular diameter ≥ 40 mm (or 21 mm/m2) and ≤55 mm (or 29 mm/m2) or 2-4 + FTR
Patient provides written Informed Consent before any study-specific tests or procedures are performed
Patient is willing and able to comply with all specified study evaluations

Exclusion Criteria:

Pregnant or lactating female
Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg)
Previous tricuspid valve repair or replacement
Myocardial Infarction or known unstable angina within the 30-days prior to the index procedure
Any PCI within 30 days prior to the index procedure or planned 3 months post the index procedure
Life expectancy of less than 12-months
Severe right heart dysfunction
Pulmonary hypertension with PA mean 2/3 rd MAP
Active systemic infection
Pericardial infection
Any clinical evidence that the investigator feels would place the patient at increased risk with the deployment of the device
Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. severe chronic obstructive pulmonary disease, hepatic failure, cardiac disease, autoimmune disorders or conditions of severe immunosuppression)
Untreated coronary artery disease (CAD) requiring revascularisation unless CABG procedure is concomitant with MIA tricuspid annular repair (surgical arm only)
Haemodynamic instability: systolic blood pressure <90mmHg without reduction of afterload, shock, need for inotropic medication or IABP
Active peptic ulcer or gastrointestinal (GI) bleeding in the past 3 months
Cerebrovascular event within the past 6 months
History of mitral/tricuspid endocarditis within the last 12 months
Organic tricuspid disease
Contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated
Known alcohol or drug abuser
Currently participating in the study of an investigational drug or device

Sites / Locations

Aarhus University HospitalRecruiting
Semmelweis University, Heart and Vascular CenterRecruiting
Centre of Cardiology, Pauls Stradins Clinical University HospitalRecruiting
Lithuanian University of Health SciencesRecruiting
Vilnius University Hospital Santariskiu KlinikosRecruiting
The Cardinal Stefan Wyszyński Institute of CardiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

MIA Surgical

MIA Percutaneous

Arm Description

Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device - Surgical from an open surgical approach

Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device - Percutaneous from a transcatheter approach

Outcomes

Primary Outcome Measures

Major Adverse Events

The percentage of participants with Major Adverse Events within 30 days of the procedure: death, Q-wave myocardial infarction, cardiac tamponade, cardiac surgery for failed MIA implantation, or stroke

Reduction in tricuspid regurgitation at 30 days

The reduction in the degree of tricuspid regurgitation compared to baseline measured post-procedure, at post-operative hospital discharge and at 1 month post-operative. Ability to reduce tricuspid regurgitation by at least 1 degree by means of quantitative echocardiographic parameters

Secondary Outcome Measures

Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADE)

The percentage of participants with Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADE) within 6 months of the procedure will be compared to the literature.

Reduction in tricuspid regurgitation

Assessment in the degree of Tricuspid Regurgitation at 3 months compared to baseline Ability to maintain improvement in tricuspid regurgitation with respect to baseline.

Quality of Life Measurement

Change in quality of life questionnaire (Minnesota Living with Heart Failure Questionnaire) compared to baseline at 6 months

Full Information

NCT ID

NCT03692598

First Posted

December 2, 2016

Last Updated

August 30, 2021

Sponsor

Micro Interventional Devices

1. Study Identification

Unique Protocol Identification Number

NCT03692598

Brief Title

Study of Transcatheter Tricuspid Annular Repair

Acronym

STTAR

Official Title

Study of Transcatheter Tricuspid Annular Repair

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (Actual)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Micro Interventional Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the study is to evaluate the safety and performance of the MIA Minimally Invasive Annuloplasty Device in patients with chronic functional tricuspid regurgitation.

Detailed Description

The purpose of the study is to evaluate the safety and performance of the MIA Minimally Invasive Annuloplasty Device in patients with chronic functional tricuspid regurgitation. The study is a prospective, multi-center safety and performance study. Enrolled subjects will be assessed for clinical follow-up at 1 month, 6 months, and 1 year post implant procedure.

6. Conditions and Keywords

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

Tricuspid Regurgitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MIA Surgical

Arm Type

Experimental

Arm Description

Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device - Surgical from an open surgical approach

Arm Title

MIA Percutaneous

Arm Type

Experimental

Arm Description

Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device - Percutaneous from a transcatheter approach

Intervention Type

Device

Intervention Name(s)

MIA, Minimally Invasive Annuloplasty Device - Surgical

Other Intervention Name(s)

MIA-S

Intervention Description

Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device from an open surgical approach

Intervention Type

Device

Intervention Name(s)

MIA, Minimally Invasive Annuloplasty Device - Percutaneous

Other Intervention Name(s)

MIA

Intervention Description

Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device from a percutaneous approach

Primary Outcome Measure Information:

Title

Major Adverse Events

Description

Time Frame

30 days

Title

Reduction in tricuspid regurgitation at 30 days

Description

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADE)

Description

The percentage of participants with Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADE) within 6 months of the procedure will be compared to the literature.

Time Frame

3 months

Title

Reduction in tricuspid regurgitation

Description

Assessment in the degree of Tricuspid Regurgitation at 3 months compared to baseline Ability to maintain improvement in tricuspid regurgitation with respect to baseline.

Time Frame

3 months

Title

Quality of Life Measurement

Description

Change in quality of life questionnaire (Minnesota Living with Heart Failure Questionnaire) compared to baseline at 6 months

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation (2-4) Age≥18 and ≤85 years old New York Heart Association (NYHA) Class II, III or ambulatory IV Left ventricular ejection fraction (LVEF) ≥30% Undergoing cardiac surgical procedure with the planned use of cardiopulmonary bypass (surgical arm only) Functional tricuspid valve regurgitation pathology with a structurally normal valve; and tricuspid valve annular diameter ≥ 40 mm (or 21 mm/m2) and ≤55 mm (or 29 mm/m2) or 2-4 + FTR Patient provides written Informed Consent before any study-specific tests or procedures are performed Patient is willing and able to comply with all specified study evaluations Exclusion Criteria: Pregnant or lactating female Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg) Previous tricuspid valve repair or replacement Myocardial Infarction or known unstable angina within the 30-days prior to the index procedure Any PCI within 30 days prior to the index procedure or planned 3 months post the index procedure Life expectancy of less than 12-months Severe right heart dysfunction Pulmonary hypertension with PA mean 2/3 rd MAP Active systemic infection Pericardial infection Any clinical evidence that the investigator feels would place the patient at increased risk with the deployment of the device Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. severe chronic obstructive pulmonary disease, hepatic failure, cardiac disease, autoimmune disorders or conditions of severe immunosuppression) Untreated coronary artery disease (CAD) requiring revascularisation unless CABG procedure is concomitant with MIA tricuspid annular repair (surgical arm only) Haemodynamic instability: systolic blood pressure <90mmHg without reduction of afterload, shock, need for inotropic medication or IABP Active peptic ulcer or gastrointestinal (GI) bleeding in the past 3 months Cerebrovascular event within the past 6 months History of mitral/tricuspid endocarditis within the last 12 months Organic tricuspid disease Contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated Known alcohol or drug abuser Currently participating in the study of an investigational drug or device

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Willard Hennemann, PhD

Phone

215 600-1273

bhennemann@microinterventional.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jeremy L West

Phone

6127566791

jwest@microinterventional.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kestutis Rucinskas, MD

Organizational Affiliation

Vilnius University Hospital, Santariskiu Klinikos

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aarhus University Hospital

City

Aarhus

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Steen H Poulsen

Facility Name

Semmelweis University, Heart and Vascular Center

City

Budapest

Country

Hungary

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bela Merkely

Facility Name

Centre of Cardiology, Pauls Stradins Clinical University Hospital

City

Riga

Country

Latvia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andrejs Erglis

Facility Name

Lithuanian University of Health Sciences

City

Kaunas

ZIP/Postal Code

50009

Country

Lithuania

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rimantas Benetis

Facility Name

Vilnius University Hospital Santariskiu Klinikos

City

Vilnius

ZIP/Postal Code

08661

Country

Lithuania

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kestutis Rucinskas, MD

Kestutis.Rucinskas@santa.lt

First Name & Middle Initial & Last Name & Degree

Vilius Janusauskus, MD

Vilius.Janusauskas@santa.lt

Facility Name

The Cardinal Stefan Wyszyński Institute of Cardiology

City

Warsaw

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marcin Demkow

12. IPD Sharing Statement

Plan to Share IPD

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Study of Transcatheter Tricuspid Annular Repair

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