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
About this trial
This is an interventional treatment trial for TAVI
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.
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
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
Learn more about this trial
Impact of Tilt Angle on Conduction Defects During Transcatheter Aortic Valve Implantation (TAVI)
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