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Accuracy of Using 2D Transesophageal Echocardiography Compared to Balloon Sizing in Determining Valve Size During Transcatheter Aortic Valve Implantation

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04242225
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : September 1, 2020
Duisburg Heart center ,Dusseldorf University ,Germany
Information provided by (Responsible Party):
Marwan Sayed Mahmoud, Assiut University

Brief Summary:

The method of transcatheter aortic valve implantation (TAVI) introduced in 2002 by Alain Cribier et al. has offered new prospects for patients with severe aortic stenosis and multiple comorbidities, who are at high operative risk(1).

The PARTNER series of randomized controlled trials has firmly established the role of TAVI with the balloon-expandable Edwards Sapien valve in patients with severe symptomatic aortic stenosis (AS) at prohibitive risk of surgery (PARTNER IA), high risk for surgery (PARTNER IB), and intermediate risk for surgery (PARTNER 2).(2)

Also PARTNER 3 and Evolut Low Risk trial strongly suggest that TAVI is not only a suitable alternative and may be superior to surgical aortic valve replacement ( SAVR) in low-risk patients.(2)

The accurate determination of the size of the implant is dependent on pre-procedural imaging. Annular measurements are important in the TAVI as inaccurate estimation can lead to complications e.g paravalvular leakage .(3) Transthoracic echocardiography (TTE), transoesophageal echocardiography (TOE), multidetector computed tomography (MDCT) and magnetic resonance imaging (MRI) have been extensively studied with respect to pre-procedural aortic annular sizing.(3).

However, even with some of the evidence returning a discrepancy in annular measurements between techniques, the literature to date does not clarify whether TOE undersizes inappropriately or appropriately with respect to MDCT.(3) In a recent study, 29.5% of patients would have been deemed ineligible for TAVI because of overestimation of annular measurements by MDCT, a figure reduced to 1.3% with the use of TOE (4)

In a recent small retrospective study, TOE, MDCT and MRI all performed comparatively well with device sizing. (5)

Balloon aortic valvuloplasty (BAV) dilatation before TAVI is considered a mandatory procedural step in the early years of TAVR. BAV is used to confirm annular sizing and to enhance trans-catheter heart valve (THV) deliverability.(6) However till now there is no comparison of annular measurement by 2D transesophgeal echocardiography with balloon sizing.

Condition or disease
Aortic Stenosis, Calcific

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Days
Official Title: Accuracy of Using 2D Transesophageal Echocardiography Compared to Balloon Sizing in Determining Valve Size During Transcatheter Aortic Valve Implantation
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. accuracy of 2D transesophgeal echocardiography compared to balloon sizining in determining size of valve during TAVI [ Time Frame: 6 months ]
    accuracy of 2D transesophgeal echocardiography compared to balloon sizining in determining size of valve during TAVI

Secondary Outcome Measures :
  1. in hospital outcomes of this approach using 2D TEE and balloon sizing only during TAVI [ Time Frame: 6 months ]
    paravalvular leakage,conduction defects ,valve embolization ,...

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with severe aortic stenosis presented for TAVI

Inclusion Criteria:

  • 1-Patients must have severe degenerative high flow AS (echocardiographic criteria: aortic valve (AV) effective orifice area (EOA) of < 1 cm2, mean AV gradient of > 40 mmHg, or AV peak systolic velocity of > 4.0 m/s) in presence of normal ejection fraction (EF).

    2- Patients must be symptomatic from the AS (dyspnea in NYHA-class II or greater, angina pectoris, or syncope), or asymptomatic but with decreased left ventricular ejection fraction, positive stress test , Pulmonary hypertension (systolic pulmonary artery pressure >60 mmHg).

    4-Symptomatic patients with severe low-flow, low-gradient (<40 mmHg) aortic stenosis with reduced ejection fraction and evidence of flow (contractile) reserve.

    3- Patients surviveal time more than one year . 4- Patients have contraindications for open chest surgery, such as :

    1. Presence of comorbidities not adequately reflected by risk scores.
    2. Procelain aorta
    3. Squelae of chest radiation.
    4. Severe chest deformation or scoliosis.
    5. Previous cardiac surgery

      Exclusion Criteria:

      1. Evidence of an acute myocardial infarction 30 days before the intended treatment.
      2. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is noncalcified.
      3. Mixed aortic stenosis and aortic regurgitation with predominant aortic regurgitation > 3+).
      4. Hemodynamic or respiratory instability within 30 days of screening evaluation.
      5. Need for emergency surgery for any reason.
      6. Hypertrophic cardiomyopathy with or without obstruction.
      7. Severe left ventricular dysfunction with LVEF <20%.
      8. Severe pulmonary hypertension and RV dysfunction.
      9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. . 10-A known contraindication to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.

      11-MRI confirmed stroke or transient ischemic attack within 6 months (180 days) of the procedure.

      12-Renal insufficiency (creatinine >3mg) and / or end stage renal insufficiency requiring chronic dialysis at the time of screening.

      13-Estimated life expectancy<12 month.

      . 14-Severe incapacitating dementia 15-Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5 cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (>5 mm), protruding or ulcerated] or narrowing of the abdominal or thoracic aorta, severe tortuosity of the thoracic aorta.

      Also a minimum iliac or femoral artery diameter of less than 6 mm may be deemed unsuitable for femoral approach.

      16-Severe mitral regurgitation. 17-Annulus size out of range of available prosthese (<18mm and >29mm). 18-Untreated coronary artery disease requiring revascularization. 19- Elevated risk of coronary ostium obstruction (asymmetric valve calcification, short distance between annulus and coronary ostium less than 10mm.

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 identifier (NCT number): NCT04242225

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Contact: Marwan Sa Mahmoud, MD 01090686492 ext 0200

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AssiutU Recruiting
Assiut, Egypt, 17717
Contact: Marwan Sa Mahmoud, MD    01090686492 ext 0200   
Sponsors and Collaborators
Assiut University
Duisburg Heart center ,Dusseldorf University ,Germany
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Principal Investigator: Marwan Sa Mahmoud, Master Assiut University
Principal Investigator: Marwan Sa Mahmoud, Master HZD
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Responsible Party: Marwan Sayed Mahmoud, Assiut university Heart Hospital, Assiut University Identifier: NCT04242225    
Other Study ID Numbers: AssiutUni
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
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
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction