Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03863132
Other study ID # REBOOT-PARADOX
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03186339 - Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI
Recruiting NCT03549559 - Imaging Histone Deacetylase in the Heart N/A
Terminated NCT02854319 - REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System N/A
Recruiting NCT05601453 - The ReTAVI Prospective Observational Registry
Withdrawn NCT05481814 - CPX in Paradoxical Low Flow Aortic Stenosis
Completed NCT02241109 - Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity N/A
Completed NCT01700439 - Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve N/A
Recruiting NCT04429035 - SLOW-Slower Progress of caLcificatiOn With Vitamin K2 N/A
Completed NCT04103931 - Impact of a Patient Decision Aid for Treatment of Aortic Stenosis N/A
Completed NCT03950440 - Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
Active, not recruiting NCT02661451 - Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD) N/A
Completed NCT02792452 - Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
Completed NCT02847546 - Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation N/A
Completed NCT02758964 - Evaluation of Cerebral Thrombembolism After TAVR
Not yet recruiting NCT02536703 - Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population Phase 3
Not yet recruiting NCT02541877 - Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve Phase 3
Completed NCT02249000 - BIOVALVE - I / II Clincial Investigation N/A
Not yet recruiting NCT02221921 - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI N/A
Active, not recruiting NCT02080299 - Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation Phase 2
Terminated NCT01939678 - Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease