NCT02226679

An Open Label Rollover Trial for Patients Randomized to the Control Group of Study LSH-10-001

An Open Label Rollover Trial for Patients Randomized to the Control Group of Study LSH-10-001 (Rollover Study for AUGMENT-HF)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: LoneStar Heart, Inc. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The objective of this extension study is to evaluate the safety and potential beneficial effects of the Algisyl-LVR™ device in patients with established heart failure secondary to a dilated cardiomyopathy. The results of this study will provide confirmatory evidence of the long-term safety and effectiveness of the Algisyl-LVR in patients with established heart failure.

Detailed description

This is a prospective, open-label evaluation of the safety and effectiveness of Algisyl-LVR in patients with dilated cardiomyopathy of either ischemic or non-ischemic origin. The evaluation for the primary measure of efficacy (Peak VO2) at 6 months will be investigator-blinded. The primary safety endpoint, while not blinded, is 30 day all-cause mortality and an objective assessment. The remaining study endpoints will evaluate the effects of the device through the evaluation of functional, structural, biochemical, and electrocardiographic evaluations at 6 and 12 months. Evaluation of adverse events and these assessments will also provide evidence of the safety profile of the device in patients with dilated cardiomyopathy. Pre-enrollment baseline patient evaluation will include clinical assessment, assessment of New York Heart Association (NYHA) functional class, blood tests, transthoracic echocardiography, MRI, electrocardiogram, cardiopulmonary exercise testing (CPX), submaximal exercise testing, and quality of life assessments. Blinded central evaluation will be performed for measures of cardiopulmonary exercise testing and cardiac imaging. \*Note: The local CPX and echocardiography measurements will be used to determine patient eligibility with respect to the peak V02 values, ejection fraction and the left ventricular end diastolic dimension indexed to body surface area (LVEDDi). The core lab values for these same assessments will be used in all statistical analyses of the study. Patient's eligible for this study completed at least 12 months of follow in the control group of the lead-in study LSH-10-001 and provided a written informed consent to participate in study LSH-001. A written informed consent to be enrolled in study LSH-11-001 is required for all patients electing participation in this roll-over study. After written patient informed consent has been obtained and verification of eligibility, patients who meet the inclusion and exclusion criteria can be included in the study and will have the Algisyl-LVR™ device (implants) administered during a surgical procedure. Patients will be considered part of this study cohort as soon as they have been hospitalized to receive the Algisyl-LVR device. The investigator will complete the "Premature Withdrawal from Follow-up" form in the patient's eCRF for study LSH-10-001 and indicate "Patient will receive the Algisyl-LVR device" as the reason for premature withdrawal from LSH-10-001. The acute response to device implant will be monitored intraoperatively via continuous electrocardiographic cardiac monitoring, arterial pressure lines, transesophageal echocardiography (TEE), and pulmonary artery catheter. Patients receiving the investigational device are expected to remain hospitalized for 5 to 14 days. Follow-up in this study is divided into two phases. During the first phase, referred to as the "efficacy phase", repeat testing of patient functional and cardiac structural parameters will be conducted at follow-up visits scheduled at 3 months and 6 months, and every 6 months thereafter. Follow-up testing will be supplemented by a 30 day (post implant) telephone contact with all patients. The efficacy phase of the trial will end on a common closing date after a minimum of 6 months of follow-up (i.e., after the last patient enrolled has been completed the 6 month visit). At that point data analysis will be performed and an initial study report will be generated. Following completion of the efficacy phase, long-term monitoring will continue through each patient's 24-month visit. This second phase is referred to as the "extended follow-up phase". During this phase, data collection will be focused on long-term safety and will be conducted at 6-month intervals.

Conditions

• Heart Failure
• Cardiomyopathy
• Dilated Cardiomyopathy

Interventions

Type	Name	Description
DEVICE	Algisyl-LVR	Algisyl-LVR™ device (implants) administered during a surgical procedure

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2014-08-27
• Last updated: 2014-08-27

Locations

2 sites across 2 countries: Italy, Romania