CAUTION -- Investigational device. Limited by Federal (or United States) law to investigational use.
AltaValve Early Feasibility Study
4C Medical Technologies, Inc. is conducting a clinical research study to evaluate the safety and performance of a new device for the treatment of severe mitral regurgitation (MR), AltaValve.
AltaValve is an investigational device that is designed for the treatment of symptomatic severe MR. AltaValve is the first transcatheter treatment to address MR without removing the mitral valve. The device’s dynamic stent and overexpansion fit accommodate the complex and variable anatomy of the mitral annulus that is intended for the treatment of a broader patient population.
To learn more about participating in research, please visit ClinicalTrials.gov
Mitral Regurgitation
- Mitral Regurgitation (MR) is the backward leakage of blood in your heart when the mitral valve does not close properly.
- It’s a common heart valve disease affecting nearly 10 percent of Americans aged ≥75 years. 1
- It’s a progressive disease and if left untreated, MR can lead to atrial fibrillation, pulmonary hypertension, heart failure and death.
Eligibility
Subjects may be enrolled in the study if ALL of the following conditions are present in the subject:
1. Subjects ≥ 18 years of age.
2. Subjects symptomatic NYHA II-IV.
3. Subjects with severe MR grade as documented by echocardiogram (assessed by Investigator).
4. Subjects who are at high risk for open-heart surgery as documented by the health care professional
(e.g., Heart Team consisting of cardiac surgeon and interventional cardiologist in United States).
1 V. Nkomo, J. Gardin, T. Skelton, J. Gottdiener, C. Scott and M. Enriquez-Sarano, "Burden of valvular heart diseases: a population-based study," Lancet (London, England), vol. 368, no. 9540, pp. 1005-1011, 16 September 2006.