NCT03082508

A Pivotal Trial to Establish the Efficacy and Safety of Algisyl in Patients With Moderate to Severe Heart Failure

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: LoneStar Heart, Inc. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

AUGMENT-HF II is a study to evaluate the efficacy and safety of the Algisyl device. The purpose of this study is to investigate Algisyl employed as a method of left ventricular augmentation and restoration in patients with dilated cardiomyopathy. Algisyl will be injected into the myocardium under direct visualization during the surgical procedure. Structural abnormalities in the heart are known to play a central role in HF, and clinical evidence supports a strong causal relationship between cardiac chamber dilation and heart failure. Because dilation, and not contractile dysfunction, appears to be responsible for the severity of the disease, the mitigation or prevention of the deleterious structural abnormalities of the left ventricle appears to be an important therapeutic target for patients with this life threatening illness. Hence, a therapy that specifically reduces LV wall stress, targets LV dilatation and LV remodeling may offer an important new alternative in the treatment of heart failure. Algisyl is being investigated based on evidence that suggests an ability of the implants to reduce wall stress, reshape the LV chamber and reduce the LV chamber size as well as prevent the progressive ventricular dilation and remodeling associated with HF. The physiologic response to progressive exercise using direct measures of ventilation and gas exchange via the cardiopulmonary exercise test is an important diagnostic tool in the management of the patient with HF, quantifying responses to therapy, and as a reliable prognostic utility for predicting outcomes in patients with HF. Numerous studies have established the strong association of peak VO2 with mortality and morbidity risk in HF. Peak VO2 conceptually is considered an overall global marker of cardiopulmonary health and is a reflection of the degree of impairment in ventricular function ( the heart's pumping capacity), oxygen delivery and oxygen utilization. Hence, employing the change in peak VO2 as a primary endpoint in this clinical study provides a strong objective measure that can be interpreted in independent blinded fashion, to evaluate the result of the therapeutic intervention and provide an equally strong assessment of the prognostic implications for patients in the study. This clinical evaluation is intended to provide confirmatory evidence of the effectiveness and safety of the device Algisyl in patients with advanced heart failure.

Conditions

• Heart Failure
• Dilated Cardiomyopathy
• Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
DEVICE	Algisyl	Algisyl device (implants) administered during a surgical procedure
DRUG	Standard Medical Therapy	as per protocol

Timeline

• Start date: 2017-08-01
• Primary completion: 2020-01-01
• Completion: 2024-01-01
• First posted: 2017-03-17
• Last updated: 2017-03-17

Regulatory

• FDA-regulated device study