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accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis (REBOOT-PARADOX)

Primary Purpose

Aortic Valve Stenosis

Status

Active

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

TAVR

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Aortic stenosis, Low flow, Low gradient, Transcatheter aortic valve replacement

Eligibility Criteria

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

Inclusion Criteria:

I1. Patients with symptomatic native aortic valve stenosis and age ≥18 years
I2. Aortic valve area (AVA) ≤ 1 cm2 or indexed AVA ≤ 0.6 cm2/m2, mean aortic gradient < 40 mmHg and stroke volume index (SVI) < 35ml/m2
I3. Left ventricular ejection fraction ≥ 50%
I4. MDCT aortic valve calcium score men > 2000AU, women > 1200AU OR the likelihood criteria are fulfilled (symptoms without other explanation and LV hypertrophy; age < 70 yrs., AVS < 0.8 cm2; SVI < 35ml/m2 confirmed by 3D TOE, MRI or invasive; reduced LV longitudinal function without other reason)
I5. Heart team agrees on eligibility for TAVR
I6. Written informed consent
I7. Negative pregnancy test in women with childbearing potential

Exclusion Criteria:

E1. Hemodynamic instability
E2. Cardiogenic shock
E3. Pre-existing mechanical or bio-prosthetic valve in any position
E4. Concomitant severe valvular heart disease
E5. Pre-existing or active endocarditis
E6. Need for heart surgery due to other conditions
E7. Aortic valve is congenital unicuspid or congenital bicuspid
E8. Hypertrophic cardiomyopathy with or without obstruction
E9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation
E10. Acute myocardial infarction within 1 month before intended AS-treatment
E11. Renal replacement therapy
E12. Estimated life expectancy < 24 months (730 days) due to carcinomas end stage liver disease or renal disease
E13. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
E14. Patient refuses aortic valve repair

Sites / Locations

Klinikum der Universität München-Großhadern

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

TAVR Group

Medical Treatment Group

Arm Description

Patients will be treated by transcatheter aortic valve repair (TAVR).

Patients will receive optimal medical treatment alone.

Outcomes

Primary Outcome Measures

Time to death

All-cause mortality

Secondary Outcome Measures

Cardiovascular mortality

Death because of cardiovascular events

Re-hospitalization due to heart failure

Number of hospital stays after randomization

Incidence of neurological events - incidence of strokes

Number of strokes

Incidence of neurological Events - incidence of transient ischaemic attacks

Number of transient ischaemic attacks

Cardiac functionality - left ventricular function

Echocardiographic measurement of left ventricular ejection fraction in %

Cardiac functionality - aortic valve hemodynamics

Measurement of aortic pressure in mmHg

Patients' quality of life

EQ5D-score in %

Device reliability

Number of reinterventions (TAVR arm only)

Full Information

NCT ID

NCT03863132

First Posted

February 27, 2019

Last Updated

March 27, 2023

Sponsor

IHF GmbH - Institut für Herzinfarktforschung

Collaborators

Boston Scientific Group, Yale University

1. Study Identification

Unique Protocol Identification Number

NCT03863132

Brief Title

accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis

Acronym

REBOOT-PARADOX

Official Title

Optimal Medical Treatment With or Without Valve Repair in Patients With Symptomatic Paradoxical Low-Flow, Low-Gradient Aortic Stenosis - a Multi-center, Randomized Comparison

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 3, 2019 (Actual)

Primary Completion Date

September 1, 2027 (Anticipated)

Study Completion Date

March 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

IHF GmbH - Institut für Herzinfarktforschung

Collaborators

Boston Scientific Group, Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Aim of this study is to evaluate whether microsurgical repair or replacement of the aortic valve is a treatment option for a subgroup of patients suffering from aortic Stenosis.

Detailed Description

Stenosis of the aortic valve leads to a narrowing of the valve, consequently to low blood flow from the heart into the Aorta, and is associated with symptoms like fatigue, breathlessness, dizziness, fainting, and chest pain. For many of the patients suffering from severe aortic stenosis surgical or catheter-assisted repair or replacement of the damaged aortic valve has been proven to be a safe and effective treatment option. Probably about 20-30% of patients suffering from severe aortic stenosis display a deviation from the usually observed disease pattern: These patients do not show the typical high pressure difference between the left ventricle (heart chamber) and the aorta (transvalvular gradient; "paradoxical" low flow/low gradient aortic stenosis). For these patients it is not yet clear, if microsurgical repair of the aortic valve (transcatheter aortic valve repair - TAVR) should be a treatment option as well. REBOOT-PARADOX evaluates whether TAVR is advantageous compared to optimal medical Treatment alone for patients suffering from paradoxical aortic stenosis. Two thirds of the participating patients will be treated by TAVR, one third will receive medical Treatment alone.

6. Conditions and Keywords

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

Aortic Valve Stenosis

Keywords

Aortic stenosis, Low flow, Low gradient, Transcatheter aortic valve replacement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Prospective, controlled, randomized (2:1), parallel group, open-label, multi-centre, international

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TAVR Group

Arm Type

Active Comparator

Arm Description

Patients will be treated by transcatheter aortic valve repair (TAVR).

Arm Title

Medical Treatment Group

Arm Type

No Intervention

Arm Description

Patients will receive optimal medical treatment alone.

Intervention Type

Device

Intervention Name(s)

TAVR

Intervention Description

Repair of defective aortic valve by microsurgical Intervention.

Primary Outcome Measure Information:

Title

Time to death

Description

All-cause mortality

Time Frame

24 months after last-patient-in

Secondary Outcome Measure Information:

Title

Cardiovascular mortality

Description

Death because of cardiovascular events

Time Frame

5 years after index treatment

Title

Re-hospitalization due to heart failure

Description

Number of hospital stays after randomization

Time Frame

5 years after index treatment

Title

Incidence of neurological events - incidence of strokes

Description

Number of strokes

Time Frame

5 years after randomization

Title

Incidence of neurological Events - incidence of transient ischaemic attacks

Description

Number of transient ischaemic attacks

Time Frame

5 years after randomization

Title

Cardiac functionality - left ventricular function

Description

Echocardiographic measurement of left ventricular ejection fraction in %

Time Frame

5 years after randomization

Title

Cardiac functionality - aortic valve hemodynamics

Description

Measurement of aortic pressure in mmHg

Time Frame

5 years after randomization

Title

Patients' quality of life

Description

EQ5D-score in %

Time Frame

5 years after randomization

Title

Device reliability

Description

Number of reinterventions (TAVR arm only)

Time Frame

5 years after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: I1. Patients with symptomatic native aortic valve stenosis and age ≥18 years I2. Aortic valve area (AVA) ≤ 1 cm2 or indexed AVA ≤ 0.6 cm2/m2, mean aortic gradient < 40 mmHg and stroke volume index (SVI) < 35ml/m2 I3. Left ventricular ejection fraction ≥ 50% I4. MDCT aortic valve calcium score men > 2000AU, women > 1200AU OR the likelihood criteria are fulfilled (symptoms without other explanation and LV hypertrophy; age < 70 yrs., AVS < 0.8 cm2; SVI < 35ml/m2 confirmed by 3D TOE, MRI or invasive; reduced LV longitudinal function without other reason) I5. Heart team agrees on eligibility for TAVR I6. Written informed consent I7. Negative pregnancy test in women with childbearing potential Exclusion Criteria: E1. Hemodynamic instability E2. Cardiogenic shock E3. Pre-existing mechanical or bio-prosthetic valve in any position E4. Concomitant severe valvular heart disease E5. Pre-existing or active endocarditis E6. Need for heart surgery due to other conditions E7. Aortic valve is congenital unicuspid or congenital bicuspid E8. Hypertrophic cardiomyopathy with or without obstruction E9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation E10. Acute myocardial infarction within 1 month before intended AS-treatment E11. Renal replacement therapy E12. Estimated life expectancy < 24 months (730 days) due to carcinomas end stage liver disease or renal disease E13. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. E14. Patient refuses aortic valve repair

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julinda Mehilli, Prof. Dr.

Organizational Affiliation

University Clinic Munich

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinikum der Universität München-Großhadern

City

München

State/Province

Bayern

ZIP/Postal Code

81377

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis

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