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

NCT03863132 | Active Not Recruiting DMC

• 1 other identifier: REBOOT-PARADOX
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time to death

  All-cause mortality

  24 months after last-patient-in

Secondary Outcomes (8)

• Cardiovascular mortality

  5 years after index treatment

• Re-hospitalization due to heart failure

  5 years after index treatment

• Incidence of neurological events - incidence of strokes

  5 years after randomization

• Incidence of neurological Events - incidence of transient ischaemic attacks

  5 years after randomization

• Cardiac functionality - left ventricular function

  5 years after randomization

Study Arms (2)

TAVR Group

ACTIVE COMPARATOR

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

Device: TAVR

Medical Treatment Group

NO INTERVENTION

Patients will receive optimal medical treatment alone.

Interventions

TAVR DEVICE

Repair of defective aortic valve by microsurgical Intervention.

TAVR Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IHF GmbH - Institut für Herzinfarktforschung: lead
• Boston Scientific Group: collaborator
• Yale University: collaborator

Study Sites (1)

Klinikum der Universität München-Großhadern

München, Bavaria, 81377, Germany

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Julinda Mehilli, Prof. Dr.

  University Clinic Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 5, 2019
• Study Start: July 3, 2019
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)