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

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Brief Title

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

Official Title

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

Brief 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.
    


Study Type

Interventional


Primary Outcome

estimate the 30 day mortality associated with the implantation of the Algisyl-LVR device


Condition

Heart Failure

Intervention

Algisyl-LVR

Study Arms / Comparison Groups

 Algisyl-LVR device implantation
Description:  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.

Publications

* 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

Device

Estimated Enrollment

24

Start Date

January 2014

Completion Date

April 2016

Primary Completion Date

April 2016

Eligibility Criteria

        Inclusion Criteria:

          1. Patients who completed at least 12 months of follow in the control group of the
             lead-in study LSH-10-001 are eligible to participate.

             Patients must have completed all study related procedures for the 12 month, 18 month
             or 24 month visit in Protocol LSH-10-001. Study procedures completed for the 12, 18 or
             24 month visit in study LSH1-10-001 will be used as the baseline (screening) and
             qualifying procedures for study LSH-11-001 if the procedure was performed within 60
             days of the date of Algisyl-LVR implant (screening procedures outside this window must
             be repeated).

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

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

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

             Evidence-based therapy for heart failure is defined as an ACE-inhibitor (ACE-I),
             and/or angiotensin II receptor blockers (ARB) for patients at stable doses for 1 month
             prior to enrollment, if tolerated, and a beta blocker (carvedilol, metoprolol
             succinate, Nebivolol or bisoprolol) for 3 months prior to enrollment, if tolerated.
             Recent up-titration of the beta blocker is acceptable if the patient has been stable
             on this dose for 1 month prior to enrollment. Stable is defined as no more than a 100%
             increase or a 50% decrease in dose. Contraindications or intolerance to therapies
             should be documented. In those intolerant to both ACE-I and ARB, combination therapy
             with hydralazine and oral nitrate should be considered. Therapeutic equivalence for
             ACE-I substitutions is allowed within the enrollment stability timelines. Aldosterone
             inhibitor therapy should be added when NYHA Class III or IV symptoms occur on standard
             therapy. If aldosterone inhibitor therapy is to be administered in NYHA Class II
             patients, it must be initiated and optimized prior to enrollment. Eplerenone requires
             dosage stability for 1 month prior to enrollment. Diuretics should be used as
             necessary to keep the patient euvolemic. All heart failure therapeutics and dosages
             should be documented in the Case Report Forms.

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

          5. 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)

          6. 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).

          7. 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 60
             days of the Algisyl-LVR procedure 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.

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

          9. 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
             procedure)

          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
      

Gender

All

Ages

18 Years - 79 Years

Accepts Healthy Volunteers

No

Contacts

Ionel Droc, MD, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT02226679

Organization ID

LSH-11-001


Responsible Party

Sponsor

Study Sponsor

LoneStar Heart, Inc.


Study Sponsor

Ionel Droc, MD, Principal Investigator, Emergency Clinic Center for The Army For the Cardiovascular Diseases


Verification Date

August 2014