Investigational device for patients with heart failure due to left heart disease
- Trial ID:
- IRB-24-8407
- Rola Khedraki, MD
Inclusion Criteria
Patients must:
- Be 18 or older with chronic symptomatic heart failure
Be symptomatic according to NYHA functional class II, III, or ambulatory IV
Meet all other inclusion criteria
Exclusion Criteria
Patients must not:
- Have greater than moderate mitral, tricuspid, or aortic regurgitation
Have known untreated carotid artery stenosis
Be expected to undergo elective major surgery within 6 months
Have a BMI >45
Additional Info
The investigational device being studied in this trial is the APTURE shunt, a metal device that is placed in the heart to create a channel allowing a small amount of blood to flow from a heart chamber with elevated pressure - the left atrium, to a heart chamber with lower pressure - the right atrium, via a blood vessel - the coronary sinus. This shunting of blood is intended to relieve the elevated pressure which can cause symptoms associated with HFmrEF and HFpEF.Contact Info:
- Clinical Research Services
- CRSLeadership@scrippshealth.org