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Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction (ROTAS)

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ClinicalTrials.gov Identifier: NCT03667365
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:

According to current European Recommendations on valvular heart disease (VHD), "classical" severe aortic stenosis (AS) is defined by an aortic valve area (AVA) ≤1 cm2 and indexed AVA ≤0.6 cm2/m2, a mean aortic pressure gradient (MAG) >40 mmHg, and a maximal aortic velocity >4 m/sec.

Aortic valve replacement (AVR) is recommended (class I indication) in patients with "classical" severe AS who have any symptoms related to aortic valve disease.

In 2007, Hachicha et al. described a particular pattern of severe AS, characterized by an AVA ≤0.6 cm2/m2, low mean pressure aortic gradient (MAG <40 mmHg), despite the presence of a preserved left ventricular ejection fraction (LVEF ≥50%). This pattern of AS is encountered in nearly 15-25 % of patients who have severe AS. Typically, these patients are elderly subjects, with several comorbidities, a small left ventricular (LV) cavity with pronounced LV concentric remodeling and a restrictive physiology, leading to a decrease in LV stroke volume despite a preserved LVEF. The diagnosis and management of patients with low gradient severe AS and preserved LVEF are often challenging because:

  1. the presence of a "true" severe aortic stenosis should be carefully confirmed by a multi-modality imaging approach;
  2. the best therapeutic management (AVR versus conservative strategy) of symptomatic patients with low gradient severe AS and preserved LVEF is not clearly established.

In very recently updated European guidelines on the management of VHD, symptomatic patients with low gradient and low flow severe AS and preserved LVEF have only a class IIa-level C indication for AVR. No specific indications are given for the management of symptomatic patients with low gradient and normal flow severe AS. This lack of indications is clearly attributed to a gap in knowledge which requires further investigations to be filled up.


Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Procedure: aortic valve replacement Other: strict clinical surveillance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction
Actual Study Start Date : March 19, 2019
Estimated Primary Completion Date : March 19, 2024
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: aortic valve replacement Procedure: aortic valve replacement
aortic valve replacement surgical or transcatheter aortic valve replacement (will be decided by the heart team before randomization)

Active Comparator: strict clinical surveillance Other: strict clinical surveillance
strict clinical surveillance strategy




Primary Outcome Measures :
  1. time from randomization to first occurrence of any of the components of the composite outcome (adjudicated): all-cause mortality or cardiovascular related hospitalization [ Time Frame: during 2 years follow-up ]

Secondary Outcome Measures :
  1. rate of all-cause mortality [ Time Frame: 2 years ]
  2. rate of cardiovascular mortality [ Time Frame: 2 years ]
  3. rate of cardiovascular related hospitalization [ Time Frame: 2 years ]
  4. rate of cerebrovascular events [ Time Frame: 2 years ]
  5. walking distance [ Time Frame: 6, 12, 18 and 24 months ]
    6-minute walking test

  6. NT-proBNP plasma levels [ Time Frame: 6, 12, 18 and 24 months ]
  7. quality of life score [ Time Frame: 6, 12, 18 and 24 months ]
    test EQ-5D



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:

  1. Age >18 years
  2. Symptomatic and severe AS defined by an effective AVA ≤1 cm² and indexed AVA ≤0.6 cm2/m2
  3. LVEF ≥50%
  4. MAG <40 mm Hg (measure confirmed by the multi-window continuous-wave Doppler interrogation and use of Pedoff probe)
  5. Confirmation of the presence of severe AS at DSE and MDCT aortic calcium score
  6. Feasibility of AVR by surgery or TAVR according to the "heart team"
  7. Signature of an informed consent

Exclusion Criteria:

  1. Uncontrolled atrial of ventricular arrhythmias
  2. Patient having a life expectancy <1 year, independently from their aortic pathology
  3. Coronary artery disease necessitating a percutaneous or surgical revascularisation
  4. Presence of a concomitant valve disease needing surgical treatment
  5. Patient who are included in another research protocol
  6. Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman and minor)

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): NCT03667365


Contacts
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Contact: Nicolas NM Mevel 02 99 28 25 55 drc@chu-rennes.fr
Contact: Anne AG Ganivet 02 99 28 25 55 anne.ganivet@chu-rennes.fr

Locations
Show Show 18 study locations
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Elena EG Galli, MD CHU Rennes
Principal Investigator: Erwan ED Donal, PhD CHU Rennes
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03667365    
Other Study ID Numbers: 35RC17_8843_ROTAS
2018-A02100-55 ( Other Identifier: N°ID-RCB )
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 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 Rennes University Hospital:
severe aortic valve stenosis
low gradient
preserved left ventricular ejection fraction
symptomatic patients
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction