Last reviewed · How we verify
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
NA trial testing TAVR in Aortic Valve Stenosis in 120 participants. Participants enrolled and being followed up; not accepting new ones.
1 September 2027
Quick facts
| Lead sponsor | IHF GmbH - Institut für Herzinfarktforschung |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 3 July 2019 |
| Primary completion | 1 September 2027 |
| Estimated completion | 1 March 2028 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- TAVR
Conditions studied
- Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →
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):
-
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 -
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:
- PubMed search for NCT03863132
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of TAVR
Trials testing the same drug.
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- NCT04347603 — Sedation or General Anesthesia During TAVR · NA · completed
- NCT04734392 — Reducing Pacemaker Implantation After TAVR With Modified Implantation Technique · completed
- NCT05721820 — Aortic Cross-clamp and Opening After Transcatheter Aortic Valve Implantation: a Real Issue? · completed
- NCT04086836 — Swedish Study on STroke After TAVR · completed
Other recruiting trials for Aortic Valve Stenosis
Currently open trials in the same condition.
- NCT07455292 — Phenotyping Left Ventricle Failure With Hemodynamic Biomarkers From 4D Flow Magnetic Resonance Imaging · NA · recruiting
- NCT07008911 — CardioHeartConnect: Commercially Available Fitness for Cardiac Rehabilitation · NA · recruiting
- NCT07145463 — Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the VitaFlow Liberty® Flex Transcatheter Aorti · NA · recruiting
- NCT07520656 — Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing · recruiting
- NCT07267117 — Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease · recruiting
Other IHF GmbH - Institut für Herzinfarktforschung trials
Trials by the same sponsor.
- NCT05717192 — BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation · NA · recruiting
- NCT04612179 — Post-Market Registry to Evaluate the Safety and Efficacy of the The SUPRAFLEX CRUZ™ Sirolimus Eluting Coronary Stent Sys · completed
- NCT04611607 — Cangrelor in Patients With Acute Myocardial Infarction Undergoing PCI After CPR, Ventilated or Cardiogenic Shock · completed
- NCT04398654 — Pulmonary Artery Sensor System Pressure Monitoring to Improve Heart Failure (HF) Outcomes · NA · active not recruiting
- NCT04335188 — COVID-19 Registry Rhineland-Palatinate (Germany) · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03863132 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IHF GmbH - Institut für Herzinfarktforschung
- Last refreshed: 4 May 2025
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing