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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02226679
Recruitment Status : Unknown
Verified August 2014 by LoneStar Heart, Inc..
Recruitment status was:  Active, not recruiting
First Posted : August 27, 2014
Last Update Posted : August 27, 2014
Information provided by (Responsible Party):
LoneStar Heart, Inc.

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.

Condition or disease Intervention/treatment Phase
Heart Failure Cardiomyopathy Dilated Cardiomyopathy Device: Algisyl-LVR Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Rollover Trial for Patients Randomized to the Control Group of Study LSH-10-001 (Rollover Study for AUGMENT-HF)
Study Start Date : January 2014
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: Algisyl-LVR device implantation
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.
Device: Algisyl-LVR
Algisyl-LVR™ device (implants) administered during a surgical procedure

Primary Outcome Measures :
  1. estimate the 30 day mortality associated with the implantation of the Algisyl-LVR device [ Time Frame: 30 days ]
    The primary safety objective is to estimate the 30 day mortality associated with the implantation of the Algisyl-LVR device

Other Outcome Measures:
  1. Change in Peak VO2 from baseline to 6 months of follow-up [ Time Frame: 6 months ]
    Change in Peak VO2 from baseline to 6 months of follow-up

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02226679

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A.O. Istituti Ospitalieri di Cremona".
Cremona, Italy
Emergency Clinic Center of The Army for The Cardiovascular Diseases
Bucharest, Romania
Sponsors and Collaborators
LoneStar Heart, Inc.
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Principal Investigator: Ionel Droc, MD Emergency Clinic Center for The Army For the Cardiovascular Diseases

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Responsible Party: LoneStar Heart, Inc. Identifier: NCT02226679     History of Changes
Other Study ID Numbers: LSH-11-001
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: August 27, 2014
Last Verified: August 2014

Keywords provided by LoneStar Heart, Inc.:
rollover study
open label

Additional relevant MeSH terms:
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Heart Failure
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases