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

Aortic Valve Stenosis Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03863132
• Other study ID #: REBOOT-PARADOX
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 3, 2019
• Est. completion date: March 1, 2028

Study information

• Verified date: March 2024
• Source: IHF GmbH - Institut für Herzinfarktforschung
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: March 1, 2028
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• TAVR
Repair of defective aortic valve by microsurgical Intervention.

Locations

Country	Name	City	State
Germany	Klinikum der Universität München-Großhadern	München	Bayern

Sponsors (3)

Lead Sponsor	Collaborator
IHF GmbH - Institut für Herzinfarktforschung	Boston Scientific Group, Yale University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to death	All-cause mortality	24 months after last-patient-in
Secondary	Cardiovascular mortality	Death because of cardiovascular events	5 years after index treatment
Secondary	Re-hospitalization due to heart failure	Number of hospital stays after randomization	5 years after index treatment
Secondary	Incidence of neurological events - incidence of strokes	Number of strokes	5 years after randomization
Secondary	Incidence of neurological Events - incidence of transient ischaemic attacks	Number of transient ischaemic attacks	5 years after randomization
Secondary	Cardiac functionality - left ventricular function	Echocardiographic measurement of left ventricular ejection fraction in %	5 years after randomization
Secondary	Cardiac functionality - aortic valve hemodynamics	Measurement of aortic pressure in mmHg	5 years after randomization
Secondary	Patients' quality of life	EQ5D-score in %	5 years after randomization
Secondary	Device reliability	Number of reinterventions (TAVR arm only)	5 years after randomization