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Trial record 7 of 229 for:    Recruiting, Not yet recruiting, Available Studies | Aortic stenosis

accuRate Evaluation of Benefit With Optimal Medical Treatment With or With-Out Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis - REBOOT-PARADOX (REBOOT-PARADOX)

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ClinicalTrials.gov Identifier: NCT03863132
Recruitment Status : Not yet recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborators:
Boston Scientific Group
Yale University
Information provided by (Responsible Party):
IHF GmbH - Institut für Herzinfarktforschung

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: TAVR Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 783 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, controlled, randomized (2:1), parallel group, open-label, multi-centre, international
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: TAVR Group
Patients will be treated by transcatheter aortic valve repair (TAVR).
Device: TAVR
Repair of defective aortic valve by microsurgical Intervention.

No Intervention: Medical Treatment Group
Patients will receive optimal medical treatment alone.



Primary Outcome Measures :
  1. Time to death [ Time Frame: 24 months after last-patient-in ]
    All-cause mortality


Secondary Outcome Measures :
  1. Cardiovascular mortality [ Time Frame: 5 years after index treatment ]
    Death because of cardiovascular events

  2. Re-hospitalization due to heart failure [ Time Frame: 5 years after index treatment ]
    Number of hospital stays after randomization

  3. Incidence of neurological events - incidence of strokes [ Time Frame: 5 years after randomization ]
    Number of strokes

  4. Incidence of neurological Events - incidence of transient ischaemic attacks [ Time Frame: 5 years after randomization ]
    Number of transient ischaemic attacks

  5. Cardiac functionality - left ventricular function [ Time Frame: 5 years after randomization ]
    Echocardiographic measurement of left ventricular ejection fraction in %

  6. Cardiac functionality - aortic valve hemodynamics [ Time Frame: 5 years after randomization ]
    Measurement of aortic pressure in mmHg

  7. Patients' quality of life [ Time Frame: 5 years after randomization ]
    EQ5D-score in %

  8. Device reliability [ Time Frame: 5 years after randomization ]
    Number of reinterventions (TAVR arm only)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863132


Contacts
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Contact: Christoph Claas, Dr. +49062159577 ext 268 claas@ihf.de
Contact: Marcel Kunadt, Dr. +49062159577 ext 223 kunadt@ihf.de

Sponsors and Collaborators
IHF GmbH - Institut für Herzinfarktforschung
Boston Scientific Group
Yale University
Investigators
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Principal Investigator: Julinda Mehilli, Prof. Dr. University Clinic Munich

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Responsible Party: IHF GmbH - Institut für Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT03863132     History of Changes
Other Study ID Numbers: REBOOT-PARADOX
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by IHF GmbH - Institut für Herzinfarktforschung:
Aortic stenosis
Low flow
Low gradient
Transcatheter aortic valve replacement

Additional relevant MeSH terms:
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Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction