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Impact of Tilt Angle on Conduction Defects During Transcatheter Aortic Valve Implantation (TAVI)

Primary Purpose

TAVI

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transcatheter aortic valve implantation
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TAVI

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 1- Intermediate or high risk patient for surgical aortic valve replacement ,EuroSCORE >15% or an STS score >10%. (13)

    2- Transfermoral approach.

    2- Contraindications for open chest surgery, such as(14) :

Expected high perioperative risk due to comorbidities not adequately reflected by scores :

  1. Squelae of chest radiation.
  2. Severe chest deformation or scoliosis.
  3. Previous cardiac surgery

Exclusion Criteria:

  • A- Clinical conditions.

    1. Active endocarditis,
    2. Myocardial infarction within 14 days
    3. Cardiogenic shock
    4. Life expectancy of less than 1 year.
    5. Patients with previously implanted Permenant Pacemakers.

B- Anatomical conditions:

  1. short distance between coronary ostia and aortic valve annulus.
  2. Size of aortic annulus out of range for TAVI(range from 18mm - 27mm)(14).
  3. Elevated risk of coronary ostium obstruction (asymmetric valve calcification, short distance between annulus and coronary ostium, small aortic sinuses).
  4. Plaques with mobile thrombi in the ascending aorta, or arch. For transfemoral/subclavian approach: inadequate vascular access (vessel size, calcification, tortuosity).
  5. left Ventricular Thrombus.

C-Severe primary associated disease of other valves or significant coronary artery disease with major contribution to the patient's symptoms that can be treated only by surgery.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    TAVI patients

    Arm Description

    Patient undergone TAVI

    Outcomes

    Primary Outcome Measures

    TILT ANGLE
    Investigate the predictors of conduction abnormalities after TAVI, and in particular the predictive role of the tilt-angle during implantation.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 6, 2019
    Last Updated
    September 6, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04083040
    Brief Title
    Impact of Tilt Angle on Conduction Defects During Transcatheter Aortic Valve Implantation (TAVI)
    Official Title
    Impact of Tilt Angle on Conduction Defects During Transcatheter Aortic Valve Implantation (TAVI)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2019 (Anticipated)
    Primary Completion Date
    December 2020 (Anticipated)
    Study Completion Date
    May 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Investigate the predictors of conduction abnormalities after TAVI, and in particular the predictive role of the tilt-angle during implantation.
    Detailed Description
    The method of transcatheter aortic valve implantation (TAVI) which was introduced in 2002 by Alain Cribier et al. has offered new prospects for patients with severe aortic stenosis and multiple comorbidities, for whom surgical procedures are associated with exceedingly high operative risk (1,2). The randomized multicenter PARTNER trial (Placement of Aortic Transcatheter valve Trial) proved that TAVI is an alternative for surgical aortic valve replacement (SAVR) for high-risk patients.TAVI is characterized by similar mortality and results in terms of reducing the symptoms of stenosis (3). Current recommendations by the European Society of Cardiology in the Guidelines on the management of valvular heart disease (4) are that TAVI should be carried out in patients with a life expectancy >1 year, who deemed inoperable or high-risk by a cardiac surgeon and who are likely to gain improvement in quality of life. (5). One of the complications based on the consensus of experts (the Valve Academic Research Consortium-2 (VARC-2 criteria)) is Conduction defect (6). The mechanical interaction of the prosthesis stent frame with the conduction system and left bundle branch may lead to a high degree of or complete AV block and to left bundle branch block (LBBB) after TAVI.(7) The pathophysiology of new conduction abnormalities has not yet been elucidated. A number of studies indicate that both patient and procedure related factors such as septal wall thickness, non-coronary cusp thickness, pre-existing RBBB, depth of valve implantation within the LVOT, post implant prosthesis expansion, and the type of prosthesis play a role , LVOT/ annulus ratio, LVOT/Prosethesis diameter..(8)(9)(10)(11)(12)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    TAVI

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    4 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TAVI patients
    Arm Type
    Other
    Arm Description
    Patient undergone TAVI
    Intervention Type
    Procedure
    Intervention Name(s)
    transcatheter aortic valve implantation
    Intervention Description
    Tilt angle. Depth of implantation of the valve. Type of the valve.(Medtronic core valve self expandable valve ,Edwards sapient balloon expandable valve
    Primary Outcome Measure Information:
    Title
    TILT ANGLE
    Description
    Investigate the predictors of conduction abnormalities after TAVI, and in particular the predictive role of the tilt-angle during implantation.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 1- Intermediate or high risk patient for surgical aortic valve replacement ,EuroSCORE >15% or an STS score >10%. (13) 2- Transfermoral approach. 2- Contraindications for open chest surgery, such as(14) : Expected high perioperative risk due to comorbidities not adequately reflected by scores : Squelae of chest radiation. Severe chest deformation or scoliosis. Previous cardiac surgery Exclusion Criteria: A- Clinical conditions. Active endocarditis, Myocardial infarction within 14 days Cardiogenic shock Life expectancy of less than 1 year. Patients with previously implanted Permenant Pacemakers. B- Anatomical conditions: short distance between coronary ostia and aortic valve annulus. Size of aortic annulus out of range for TAVI(range from 18mm - 27mm)(14). Elevated risk of coronary ostium obstruction (asymmetric valve calcification, short distance between annulus and coronary ostium, small aortic sinuses). Plaques with mobile thrombi in the ascending aorta, or arch. For transfemoral/subclavian approach: inadequate vascular access (vessel size, calcification, tortuosity). left Ventricular Thrombus. C-Severe primary associated disease of other valves or significant coronary artery disease with major contribution to the patient's symptoms that can be treated only by surgery.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dina Moubasher, Msc
    Phone
    01069188810
    Email
    dinatantash@gmail.com

    12. IPD Sharing Statement

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