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

NCT02226679 | Unknown DMC

• 1 other identifier: LSH-11-001
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 2

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.

Conditions

Heart Failure; Cardiomyopathy; Dilated Cardiomyopathy

Keywords

crossover; rollover study; open label

Outcome Measures

Primary Outcomes (1)

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

  The primary safety objective is to estimate the 30 day mortality associated with the implantation of the Algisyl-LVR device

  30 days

Other Outcomes (1)

• Change in Peak VO2 from baseline to 6 months of follow-up

  6 months

Study Arms (1)

Algisyl-LVR device implantation

EXPERIMENTAL

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

Interventions

Algisyl-LVR DEVICE

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

Algisyl-LVR device implantation

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• The patients must be able and willing to give written informed consent
• The patients will be adult (age ≥ 18 years and ≤ 79 years) males or females
• 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
• 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)
• 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).
• 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.
• Patient's surgical risk must be considered reasonable and the evaluation of surgical risk should include review of coronary and left ventricular angiography.
• 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.

You may not qualify if:

• Patients for whom it is planned to receive CABG, MVR, heart transplantation or LVAD within the next 6 months
• Patients presenting with cardiogenic shock
• 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
• Patients presenting with a restrictive cardiomyopathy such as due to amyloidosis, sarcoidosis, or hemochromatosis
• Patient with a history of constrictive pericarditis
• Patients with a Q wave myocardial infarction (MI) within the last 30 days
• Patients with a recent history of stroke (within 60 days prior to the surgical procedure)
• 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)
• Patients with a serum creatinine \> 2.5 mg/dL
• Clinically significant liver enzyme abnormalities, i.e., AST(SGOT) and ALT (SGPT) more than 2.5 times the upper limit of normal
• History of severe COPD (i.e., FEV 1\< 1 liter or FEV1 \< 50% predicted)
• 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
• 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

Sponsors & Collaborators

• LoneStar Heart, Inc.: lead

Study Sites (2)

A.O. Istituti Ospitalieri di Cremona".

Cremona, Italy

Location

Emergency Clinic Center of The Army for The Cardiovascular Diseases

Bucharest, Romania

Location

MeSH Terms

Conditions

Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiomegaly; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ionel Droc, MD

  Emergency Clinic Center for The Army For the Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: August 27, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 27, 2014

Record last verified: 2014-08

Locations

IT (1); RO (1)