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NCT03863132: REBOOT-PARADOX

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

Active, enrolled NA Last updated 4 May 2025
What this trial tests

NA trial testing TAVR in Aortic Valve Stenosis in 120 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
3 July 2019
Primary endpoint
1 September 2027
1 March 2028

Quick facts

Lead sponsorIHF GmbH - Institut für Herzinfarktforschung
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment120
Start date3 July 2019
Primary completion1 September 2027
Estimated completion1 March 2028
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

IHF GmbH - Institut für Herzinfarktforschung — full company profile →

Who can join

18 and older, any sex, with Aortic Valve Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. TAVI in patients with low-flow low-gradient aortic stenosis-short-term and long-term outcomes.
    Steffen J, Reißig N, Andreae D, Beckmann M, et al · · 2022 · cited 23× · PMID 35320407 · DOI 10.1007/s00392-022-02011-4
  2. Right ventricular dysfunction and impaired right ventricular-pulmonary arterial coupling in paradoxical low-flow, low-gradient aortic stenosis.
    Nies RJ, Nettersheim FS, Braumann S, Ney S, et al · · 2024 · cited 5× · PMID 38887164 · DOI 10.1002/ejhf.3329

Verify or expand the search:

Other trials of TAVR

Trials testing the same drug.

Other recruiting trials for Aortic Valve Stenosis

Currently open trials in the same condition.

Other IHF GmbH - Institut für Herzinfarktforschung trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03863132.

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