A Randomized, Controlled Study to Evaluate Algisyl-LVR™ as a Method of Left Ventricular Augmentation for Heart Failure

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Brief Title

A Randomized, Controlled Study to Evaluate Algisyl-LVR™ as a Method of Left Ventricular Augmentation for Heart Failure

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)

Brief Summary

      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.

Detailed Description

      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

Study Phase

Phase 2/Phase 3

Study Type


Primary Outcome

peak VO2

Secondary Outcome

 30 day all cause mortality


Heart Failure



Study Arms / Comparison Groups

Description:  Algisyl-LVR™ device (implants) administered during a surgical procedure.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

August 2012

Completion Date

May 2016

Primary Completion Date

April 2014

Eligibility Criteria

        Inclusion Criteria:

          1. The patients must be able and willing to give written informed consent

          2. The patients will be adult (age ≥ 18 years and ≤ 79 years) males or females

          3. The patients must be on stable, evidence-based therapy for heart failure

             * Note: CRT or CRT-D are acceptable co-therapy, if placed > 3 months before
             randomization or the investigator does not anticipate within 6 months after

          4. The patients will have a left ventricular ejection fraction equal to or less than 35%
             via echocardiography, cardiac catheterization, radionuclide scan, or magnetic
             resonance imaging (measured within the last 30 days)

          5. The patients will have a left ventricular end diastolic dimension indexed to body
             surface area (LVEDDi) of 30 to 40mm/m2 (LVEDD/BSA) (measured within the last 30 days)

          6. Patients must have symptomatic heart failure with a Peak VO2 of 9.0 - 14.5 ml/min/kg
             (performed using a bicycle ergometer). Patients must perform two CPX tests (within 30
             days of randomization and performed at least 20 hours apart) that differ by no more
             than 15% in the observed value for Peak VO2 and have a mean value of 9.0 - 14.5
             ml/min/kg from these two tests.

          7. Patient's surgical risk must be considered reasonable and the evaluation of surgical
             risk should include review of coronary and left ventricular angiography

          8. If female, the patients must be (a) post-menopausal, (b) surgically sterile, or (c)
             using adequate birth control and have a negative serum pregnancy test within 7 days
             prior to administration of study device

        Exclusion Criteria:

          1. Patients for whom it is planned to receive CABG, MVR, heart transplantation or LVAD
             within the next 6 months.

          2. Patients presenting with cardiogenic shock.

          3. Patients who have undergone a previous mid-sternotomy surgical procedure are excluded
             unless the surgeon's assessment is that the left sided limited thoracotomy is feasible
             and considered reasonable surgical risk.

          4. Patients presenting with a restrictive cardiomyopathy such as due to amyloidosis,
             sarcoidosis, or hemochromatosis

          5. Patient with a history of constrictive pericarditis

          6. Patients with a Q wave myocardial infarction (MI) within the last 30 days

          7. Patients with a recent history of stroke (within 60 days prior to the surgical

          8. A left ventricular (LV) wall thickness of the LV free-wall, at the mid-ventricular
             level, of less than 8 mm (screening echocardiography must confirm a minimum wall
             thickness of 8 mm)

          9. Patients with a serum creatinine > 2.5 mg/dL

         10. Clinically significant liver enzyme abnormalities, i.e., AST(SGOT) and ALT (SGPT) more
             than 2.5 times the upper limit of normal

         11. History of severe COPD (i.e., FEV 1< 1 liter or FEV1 < 50% predicted)

         12. The patients will not be receiving concurrently an investigational Product in another
             clinical trial or have received an investigational Product in another clinical trial
             in the 30 days prior to enrollment

         13. A life expectancy of less than 1 year or any other condition that, in the opinion of
             the clinical investigator, might compromise any aspect of the trial




18 Years - 79 Years

Accepts Healthy Volunteers



Maurizio Volterani, MD, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor

LoneStar Heart, Inc.

Study Sponsor

Maurizio Volterani, MD, Principal Investigator, IRCCS San Raffaele Pisana

Verification Date

March 2017