An observational study in ATTR Amyloidosis Wild Type, Severe Aortic Stenosis and Aortic Valve Stenosis, sponsored by Jordan Collaborating Cardiology Group. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-08-29.
Sponsored by Jordan Collaborating Cardiology Group · Observational
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.
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. Two hypotheses may explain this association
Transarterial AV replacement (TAVI) is the treatment of choice for elderly patients with severe calcific AS. Studies have shown a prevalence of about 10% of ATTR cardiac amyloidosis in patients undergoing TAVI. The diagnosis is based on a positive nuclear scan (PYP, DPD or HMDP) and ruling out AL amyloidosis in patients with positive scans. While studies have shown no impact of ATTR on prognosis in TAVI patients, there is evidence of poorer quality of life, increased in-hospital acute ischemic stroke, increased cardiac and heart failure hospitalizations, increased conduction abnormalities, compared to patients without ATTR undergoing TAVI.
The prevalence of ATTR in TAVI patients in Jordan and Middle Eastern populations has not been previously evaluated. The purpose of this study is to evaluate the prevalence of ATTR cardiac amyloidosis in elderly Middle Eastern patients undergoing TAVI and to document the clinical characteristics, procedural outcomes and 1 year follow up of such patients compared to patients without ATTR.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 435 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Jordan Collaborating Cardiology Group is the lead sponsor of 26 studies on the registry; 7 are open to participants now.
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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.
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Exclusion Criteria:
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.
Time frame: 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.
Time frame: One year after enrollment: up to 30 days after the passage of 365 days after the TAVR procedure
No study locations are listed for this record.
This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Jordan Collaborating Cardiology Group