Prevalence of ATTR Cardiac Amyloidosis in Patients Undergoing TAVR

NCT06015997 | Unknown

• 1 other identifier: ANAC.JO.2023.ATTR.TAVR.ME
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

ATTR-cardiac amyloidosis (CA) is present in 4% to 16% of elderly patients with severe calcific aortic stenosis (AS). The reasons for this association are not fully known. It is hypothesized that an amyloidotic infiltration of the aortic valve acts as a trigger for the development of endothelial damage and subsequent calcification. Elderly patients undergoing TAVI will be evaluated for the presence of ATTR-CA in Jordan.

Conditions

ATTR Amyloidosis Wild Type; Severe Aortic Stenosis; Aortic Valve Stenosis; Middle East Studies

Keywords

ATTR cardiac amyloidosis; Severe aortic stenosis; Transarterial aortic valve replacement

Outcome Measures

Primary Outcomes (2)

• Prevalence of ATTR CA in TAVR patients

  Consecutive elderly (≥65 years) patients who are undergoing TAVI will be included. Patients will be invited to undergo a pyruvate PO4 (PYP) scan. Patients with positive scans will undergo further testing to rule out AL amyloidosis (Free light chain assay, SIFEP, UIFEP). Data collection will include all pertinent clinical characteristics, peri- procedural details.

  On admission ( from time of admission to time of discharge from the hospital) and within 10 days.

• Cardiovascular event at One year follow up

  Events at one year defined as the occurrence of all-cause death, and hospital admission for heart failure or aortic valve reintervention.

  One year after enrollment: up to 30 days after the passage of 365 days after the TAVR procedure

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive elderly patients, 65 years of age or older, with a diagnosis of severe aortic stenosis who undergo TAVR will be evaluated for the possible diagnosis of an underlying ATTR cardiac amyloidosis.

You may qualify if:

• Age ≥65 years
• Severe aortic stenosis
• Patient underwent TAVR procedure
• Positive pyruvate PO4 scan

You may not qualify if:

• Diagnosis of AL amyloidosis base on free light chain assay, serum and urine immune electrophoresis.

Sponsors & Collaborators

• Jordan Collaborating Cardiology Group: lead

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Ramzi Tabbalat, MD, FACC

CONTACT

00962795535522; ramzi_md@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 29, 2023
• Study Start: October 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: November 1, 2025
• Last Updated: August 29, 2023

Record last verified: 2023-08