NCT05384418

Cardiac Amyloidosis Prevalence and Outcome in Aortic Stenosis Patients Undergoing Transcatheter Aortic Valve Implantation

Cardiac AMyloidosis Prevalence and Outcome in Aortic Stenosis Patients Undergoing Transcatheter Aortic Valve Implantation (CAMPOS-TAVI)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: CHU de Reims · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Aortic stenosis (AS) is the most frequent valvulopathy in the general population in France and more generally in developed countries, due to populations aging. Its standard treatment is historically surgical aortic valve replacement (SAVR). In the 2000s, the management of this valvulopathy was revolutionized by the development of the technique of per-cutaneous aortic valve replacement (TAVI). TAVI opens the possibility of curative treatment to patients at high operational risk not operable by conventional surgery, and for whom outcome was affected with high mortality under medical treatment alone. Amyloidosis, a pathology with multiple etiologies, is a rare condition and its cardiac form (AC) even more (8 to 17 / 100,000 people / year). However, its prevalence is increasing. Some autopsies series have found prevalence up to 50% of cardiac amyloidosis with transthyretin (AC-TTR) after 60 years. In addition, recent data suggested that AC-TTR prevalence is higher in the population of patients with heart disease: 13% in heart failure with preserved ejection fraction and up to 16% in patients with AS. The outcome of patients with AC-TTR remains unknown after TAVI. Thus, the diagnosis of AC-TTR in patients undergoing TAVI represents an important issue. Indeed, a treatment stabilizing the process of accumulation of transthyretin deposits, effective on the survival of these patients, is now available. In addition, a non-invasive screening strategy for AC-TTR, alternative to biopsy, is now validated.

Detailed description

The aim of the study is to describe prevalence of cardiac amyloidosis with transthyretin in patients undergoing transcatheter aortic valve implantation.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
RADIATION	HDP-Tc99m bone scintigraphy	HDP-Tc99m bone scintigraphy

Timeline

• Start date: 2020-12-09
• Primary completion: 2022-09-16
• Completion: 2022-09-16
• First posted: 2022-05-20
• Last updated: 2024-09-23

Locations

1 site across 1 country: France