Impact of Tilt Angle on Conduction Defects During Transcatheter Aortic Valve Implantation (TAVI)
1 other identifier
interventional
4
0 countries
N/A
Brief Summary
Investigate the predictors of conduction abnormalities after TAVI, and in particular the predictive role of the tilt-angle during implantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2019
CompletedFirst Posted
Study publicly available on registry
September 10, 2019
CompletedStudy Start
First participant enrolled
December 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedSeptember 10, 2019
September 1, 2019
1 year
September 6, 2019
September 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
TILT ANGLE
Investigate the predictors of conduction abnormalities after TAVI, and in particular the predictive role of the tilt-angle during implantation.
1 year
Study Arms (1)
TAVI patients
OTHERPatient undergone TAVI
Interventions
1. Tilt angle. 2. Depth of implantation of the valve. 3. Type of the valve.(Medtronic core valve self expandable valve ,Edwards sapient balloon expandable valve
Eligibility Criteria
You may qualify if:
- Intermediate or high risk patient for surgical aortic valve replacement ,EuroSCORE \>15% or an STS score \>10%. (13)
- Transfermoral approach.
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DR
Study Record Dates
First Submitted
September 6, 2019
First Posted
September 10, 2019
Study Start
December 1, 2019
Primary Completion
December 1, 2020
Study Completion
May 1, 2021
Last Updated
September 10, 2019
Record last verified: 2019-09