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

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

Study Overview

• Status: Unknown
• Conditions: TAVI
• Intervention / Treatment: Procedure: transcatheter aortic valve 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)

• Study Type: Interventional
• Enrollment (Anticipated): 4
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dina Moubasher, Msc; Phone Number: 01069188810; Email: dinatantash@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: TAVI patients; Patient undergone TAVI	Procedure: transcatheter aortic valve implantation; Tilt angle.; Depth of implantation of the valve.; Type of the valve.(Medtronic core valve self expandable valve ,Edwards sapient balloon expandable valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TILT ANGLE	Investigate the predictors of conduction abnormalities after TAVI, and in particular the predictive role of the tilt-angle during implantation.	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2019
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): May 1, 2021

Study Registration Dates

• First Submitted: September 6, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (ACTUAL): September 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 6, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease
• Other Study ID Numbers: tilt angle during TAVI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No