Heart Failure Clinical Trial
Official title:
A Randomized, Controlled Study to Evaluate the Safety and Cardiovascular Effects of Algisyl-LVR™ as a Method of Left Ventricular Augmentation in Patients With Dilated Cardiomyopathy (AUGMENT-HF)
This is a pilot study to evaluate the safety and efficacy of the Algisyl-LVR™ device. The
purpose of this study is to investigate Algisyl-LVR™ employed as a method of left
ventricular augmentation and restoration in patients with dilated cardiomyopathy.
Algisyl-LVR™ will be injected into the myocardium under direct visualization during the
surgical procedure.
This study will evaluate the concept that direct mid left ventricular (LV) intramyocardial
injections of Alginate hydrogel implants into the free wall of the failing LV will reduce LV
size, restore LV shape, lower LV wall stress and improve global LV function.
The Primary Efficacy Endpoint of the study is the change in Peak VO2 (maximum oxygen uptake)
from baseline to 6 months of follow-up. The Primary Safety Endpoint of the study is to
estimate the 30 day mortality associated with the implantation of the Algisyl-LVR device
The hypothesis of the study is that there is a statistically significant difference in
change in Peak VO2 from baseline to 6 month follow-up when the medically managed arm is
compared to the Algisyl-LVR arm, i.e. the Algisyl LVR arm is superior to medical management.
This is a prospective, randomized, parallel group evaluation of the safety and effectiveness
of Algisyl-LVR in patients with dilated cardiomyopathy of either ischemic or non-ischemic
origin. The evaluation for primary efficacy endpoint (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, chest x-ray,
echocardiography, magnetic resonance imaging (MRI), electrocardiogram, cardiopulmonary
exercise testing, submaximal exercise testing, and quality of life assessments. Blinded
central evaluation will be performed for measures of cardiopulmonary exercise testing, blood
tests, Holter Monitors and cardiac imaging.
After written patient informed consent has been obtained and verification of eligibility,
patients who meet the selection criteria will be randomized. All patients must be on stable,
evidence-based therapy for heart failure. Patients assigned to the Investigational Device
group will have the Algisyl-LVR™ device (implants) administered during a surgical procedure.
For patients randomized to the investigational device group, the investigator will make
every attempt to minimize the time between randomization and surgery (i.e, no more than 7 to
10 days). Patients will be considered part of the study cohort as soon as they have been
randomly allocated to either the Treatment or Control group. This time point will also be
considered as the start of follow-up. For patients allocated to the Investigational Device
group, the starting point of follow-up for surgical mortality and surgical complications
will start as of the date when the surgical procedure is performed (or attempted). 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. Patients
assigned to the control group will continue on standard medical therapy (without the
investigational device).
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 randomization)
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.
Patient's randomized to the control group and completing the 12 month visit will be provided
the option of enrolling in Clinical Study LSH-11-001: An Open Label Rollover Trial for
Patients Randomized to the Control Group of Study LSH-10-001. Patients must continue to meet
the inclusion and exclusion criteria as stated in Study LSH-10-001 to be eligible for Study
LSH-11-001.
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