Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis (AVATAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02436655
Recruitment Status : Completed
First Posted : May 7, 2015
Last Update Posted : January 12, 2022
Sponsor:
Information provided by (Responsible Party):
Marko Banovic, Clinical Centre of Serbia

Brief Summary:
Whether to intervene in asymptomatic patients with severe aortic stenosis and normal left ventricular ejection fraction remains controversial. The investigators therefore try to compare clinical outcomes of elective aortic valve replacement to conventional treatment and watchful waiting strategy in a prospective randomized trial.

Condition or disease Intervention/treatment Phase
Aortic Stenosis Procedure: surgical aortic valve replacement Not Applicable

Detailed Description:

Aortic valve replacement (AVR) therapy is obvious choice in symptomatic severe aortic stenosis (AS) patients, because it improves symptoms, LV function and survival. Therefore, the accurate diagnosis of the disease, determination of its severity and precise evaluation of patients' clinical status is essential. However, the treatment decisions and indication for AVR in asymptomatic patients with severe AS and normal left ventricular ejection fraction (LV EF) are vague and the subject of ongoing debate. The most recent European and American guidelines have class I indication for AVR in asymptomatic severe AS patients with normal LV EF only in patients already scheduled for other cardiac surgery (for example by-pass surgery). In the case of symptom positive stress test American and European guideline differs, with European guidelines having class I indication and American guidelines only IIb indication. In all those cases of asymptomatic severe AS patients with normal LV EF the level of evidence is C, in other words there are no randomized trials. The consequence is that the decisions are made individually, patient by patient, and for this reason a patient with identical echocardiographic/clinical characteristics might be operated in USA but not in Europe (or any other part in the world), and vice-versa.

With the experience that has accumulated so far, there are retrospective and observational data that elective AVR might lead to favorable outcome compared to late (after symptom onset) surgery. This may especially come to attention with the understanding that annual risk of sudden cardiac death in asymptomatic severe AS patients with normal LV EF might be very similar or even a bit higher than operative mortality in experienced cardiac surgery centers.

Nevertheless, the majority of cardiologist worldwide are reluctant to send their asymptomatic patient with isolated severe AS and normal LV EF to AVR, and it will probably stay like that till randomized trials give us an answer whether elective AVR is beneficial.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis: (AVATAR Trial): A Multicentre Randomized Controlled Trial
Actual Study Start Date : June 2015
Actual Primary Completion Date : May 2021
Actual Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: conventional drug treatment
conservative treatment and watchful waiting till symptom onset (then aortic valve replacement). Other indications for aortic valve replacement include reduced left ventricular systolic function
Active Comparator: elective aortic valve replacement
elective aortic valve surgery (replacement) within 4 weeks after randomization
Procedure: surgical aortic valve replacement
open heart aortic valve replacement




Primary Outcome Measures :
  1. all cause death, Major Adverse Cardiac Event (MACE) including: ( Acute Myocardial Infarction - AMI, Stroke - CVI, unplanned hospitalization for Heart failure (HF) needing intravenous treatment [ Time Frame: 36 months ]
  2. all cause death, Major Adverse Cardiac Event (MACE) including: ( Acute Myocardial Infarction - AMI, Stroke - CVI, unplanned hospitalization for Heart failure (HF) needing intravenous treatment [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. in-hospital and 30 days operative mortality in operated patients in both groups [ Time Frame: 30 days ]
  2. repeat aortic valve surgery in operated patients in both groups [ Time Frame: 5 years ]
  3. major bleeding according to consensus report from the Bleeding Academic Research Consortium [ Time Frame: 5 years ]
  4. thromboembolic complications based on clinical symptoms, signs and imaging studies [ Time Frame: 5 years ]
  5. repeated major adverse cardiovascular events [ Time Frame: 5 years ]
  6. all-cause death + heart failure hospitalization [ Time Frame: 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • men and women of any ethnic origin aged ≥18 years
  • Written informed consent
  • V max across the aortic valve > 4m/s or Pmean ≥ 40mmHg and AVA ≤ 1cm2 or AVAi ≤ 0.6cm2/m2 at rest
  • Without reported symptoms
  • Society of Thoracic Surgeons (STS) score < 8%

Exclusion Criteria:

  • Participation in another clinical trial within 30 days prior randomization
  • Pregnant or nursing women
  • Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
  • Positive stress-test defined as:

    1. Anginal chest pain during testing
    2. Syncope, dizziness during testing
    3. Decrease in systolic blood pressure during exercise ≥ 20mmHg
    4. Malignant arrhythmia during exercise testing (VT or VF)
  • Left ventricular ejection fraction < 50% at rest
  • Very severe AS (defined as Vmax > 5.5 m/s at rest)
  • Significant disease of other valves (Mitral stenosis with Pmean > 5mg, or any significant regurgitation ≥ 3+
  • Recent AMI (< 1 year)
  • Need for additional by-pass surgery or for aortic root replacement (i.e Bentall) or ascending aorta in asymptomatic patients undergoing AVR
  • Previous by-pass surgery
  • Previous any heart valve surgery
  • Impaired renal function, i.e. creatinine >200 µmol/L or glomerular filtration rate < 30 mL/min/1.73 m2
  • Significant pulmonary hypertension at rest (PASP > 50mmHg)
  • Uncontrolled hypertension at rest (systolic >180 mmHg and diastolic >100 mmHg)
  • Significant co-morbidity with reduced life expectance (< 3 years)
  • Uncontrolled Diabetes Mellitus (HbA1C > 9 %)
  • Significant COPD (FEV1 < 70% of predicted value)
  • Permanent or paroxysmal atrial fibrillation

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): NCT02436655


Locations
Layout table for location information
Belgium
Cardiovascular Center Aalst
Aalst, Belgium, 9320
Croatia
University Clinical Center "Rebro"
Zagreb, Croatia
University Clinical Center ''Sestre milosrdnice''
Zagreb, Croatia
Czechia
University Hospital Brno
Brno, Czechia, 62500
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czechia, 14021
France
Hôpital Cardiologique de Haut Lévèque
Pessac, France, 33604
Ireland
University Hospital Galway
Galway, Ireland
Italy
Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy
Lithuania
Vilnius University Hospital Santariskiu klinikos
Vilnius, Lithuania, 08661
Poland
Medical University of Silesia
Katowice, Poland, 40005
Serbia
Cardiovascular Center 'Dedinje"
Belgrade, Serbia, 11000
CCSerbia
Belgrade, Serbia, 11000
University Clinical Centre Zvezdara
Belgrade, Serbia, 11000
Insitute for Cardiovascular Diseases "Sremska Kamenica"
Novi Sad, Serbia
Sponsors and Collaborators
Clinical Centre of Serbia
Investigators
Layout table for investigator information
Principal Investigator: Marko Banovic, MD, PhD, FESC, FACC Cardiology Department, University Clinical Centre of Serbia
Principal Investigator: Svetozar Putnik, MD, PhD Cardiac Surgery Department, University Clinical Centre of Serbia
  Study Documents (Full-Text)

Documents provided by Marko Banovic, Clinical Centre of Serbia:
Statistical Analysis Plan  [PDF] January 4, 2021

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Marko Banovic, MD PhD, FESC, FACC, Assistant Professor, Clinical Centre of Serbia
ClinicalTrials.gov Identifier: NCT02436655    
Other Study ID Numbers: FWA00011929
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: January 12, 2022
Last Verified: December 2021
Keywords provided by Marko Banovic, Clinical Centre of Serbia:
aortic stenosis
normal ejection fraction
asymptomatic
Additional relevant MeSH terms:
Layout table for MeSH terms
Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction