Heart Failure Clinical Trial

IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction

Summary

The primary objective is to evaluate the safety and effectiveness of the IK-5001 device for the prevention of ventricular remodeling and congestive heart failure when administered to subjects who had successful percutaneous coronary intervention with stent placement after ST segment elevation MI (STEMI).

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Full Description

Heart failure is a significant problem, and carries substantial mortality. According to studies, left ventricular (LV) remodeling contributes independently to heart failure progression. Prevention and reversal of LV remodeling are correlated with decreased risk of death and heart failure events. IK-5001 is an implantable device to be used in subjects with recent myocardial infarction (MI). The IK-5001 device has been shown to directly halt the remodeling process that occurs following acute MI. IK-5001 replaces the damaged extracellular matrix (ECM) that has degraded during infarction, supports the damaged myocardial tissue, prevents local dyskinesis, and decreases wall stress. Because of its minimal interaction with the myocardium, its mechanism of action, its lack of specific pharmacologic activity and its elimination behavior, IK-5001 is a medical device in concurrence with the Global Harmonization Task Force's harmonized definition for medical devices.

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria:

Subjects must meet all of the following inclusion criteria to participate in this trial:

The subject is ≥ 18 years of age.
The subject has given informed consent.

The subject has experienced a large STEMI defined by the following criteria:

Peak cardiac enzyme value within 48 hours of symptom onset as follows:

Creatine kinase MB fraction (CK-MB) > 30 x the upper limit of normal OR
Troponin I > 200 x upper limit of normal OR
Troponin T > 60 x the upper limit of normal

AND at least 1 of the following 3 criteria:

Delayed presentation with PCI > 6 hours from onset of symptoms
Significant new Q waves in ≥ 2 anterior leads or anterior ST segment elevation of at least 3 mm persistent at 24 hours after PCI
New onset of CHF (Killip class 3-4) or cardiogenic shock persistent at 24 hours after PCI

AND at least 1 of the following 2 criteria:

MI ≥ 20% by Single Photon Emission Computed Tomography scan (SPECT) or cardiac Magnetic Resonance Imaging (MRI) with defect in the appropriate distribution
Ejection fraction ≤ 35% with wall motion abnormality in the appropriate distribution at baseline imaging assessment
The subject has had successful PCI with stent within 48 hours of symptom onset, and residual stenosis less than 20% in the infarct related artery and greater than or equal to thrombolysis in myocardial infarction (TIMI) 2 flow. Subjects undergoing rescue PCI after thrombolysis or delayed presentation with ongoing ischemia may be enrolled.
For Germany only: Patients determined to have Killip class 4 at time of device deployment are not eligible for randomization.
For Germany only: If SPECT is used for determination of MI size in order to meet inclusion criteria, the SPECT must have been previously performed as part of standard clinical care. SPECT is not to be performed solely to qualify a patient for this study in Germany.

Exclusion criteria:

Subjects will be excluded from participating in this trial if ANY of the following exclusion criteria are met:

Any subject with cardiogenic shock requiring mechanical ventilation or mechanical support at the time of deployment. Subject must be off mechanical support prior to deployment.
Need for urgent coronary artery bypass graft (CABG)
Clinically significant valvular heart disease with planned surgical correction or transcatheter aortic valve implantation (TAVI)
Uncontrolled ventricular arrhythmias
Renal insufficiency with a calculated creatinine clearance of less than 30 mL/ minute. See Appendix A for determining estimated creatinine clearance.
Clinically significant hepatic insufficiency
Inadequate imaging windows (defined as the inability to visualize the endocardial border of at least 16 of the 17 segments in both the apical four chambers and apical two chamber views without foreshortening) or arrhythmia that would preclude adequate 3D imaging on transthoracic echocardiography at the local baseline echo assessment
Non-ambulatory prior to the index MI
The subject has participated in another trial of an investigational agent within 30 days prior to randomization.
Subject has received resorbable stent as part of PCI.
The subject is pregnant or breastfeeding. Women of child-bearing potential will have a negative urine pregnancy test prior to randomization.
Any other concurrent condition that, in the opinion of the investigator, would prevent completion of the clinical trial, including inability to comply with follow up requirements.
For Germany only: In the investigator's opinion, the patient is not expected to survive ≥12 months.
For Germany only: 24 hours prior to device deployment, the patient has a serum calcium level greater than the upper limit of normal as determined by the local laboratory.

Study is for people with:

Heart Failure

Estimated Enrollment:

303

Study ID:

NCT01226563

Recruitment Status:

Completed

Sponsor:

Bellerophon BCM LLC

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There are 78 Locations for this study

See Locations Near You

Cardiology, P.C.
Birmingham Alabama, 35211, United States
Harbor - UCLA Medical Center
Torrance California, 90509, United States
MedStar Washington Hospital Center
Washington District of Columbia, 20010, United States
University of Florida
Gainesville Florida, 32610, United States
University of Miami Hospital
Miami Florida, 33136, United States
St. Vincent Medical Group Inc.
Indianapolis Indiana, 46290, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Minneapolis Heart Institute
Minneapolis Minnesota, 55407, United States
Montefiore Medical Center Weiler Division
Bronx New York, 10461, United States
Stony Brook Medicine
Stony Brook New York, 11794, United States
East Carolina Heart Institute - ECHI
Greenville North Carolina, 27834, United States
Carl and Edyth Lindner Center for Research and Education @ Christ Hospital
Cincinnati Ohio, 45219, United States
Ohio Health Research Institute
Columbus Ohio, 43214, United States
Penn State Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Princess Alexandra Hospital
Woolloongabba Brisbane, 4102, Australia
Gold Coast Hospital
Southport Queensland, 4215, Australia
The Queen Elisabeth Hospital
Woodville South South Australia, 5011, Australia
Alfred Hospital
Melbourne Victoria, 3004, Australia
The Northern Hospital
Melbourne Victoria, 3076, Australia
Flinders Medical Centre
Bedford Park , 5042, Australia
Royal Perth Hospital - Dept. of Cardiology
Perth , 6000, Australia
ZNA Middelheim
Antwerpen , 2020, Belgium
Universitair Ziekenhuis Brussel
Brussel , 1090, Belgium
Ziekenhuis Oost-Limburg (ZOL)
Genk , 3600, Belgium
CHU du Sart Tilman
Liege , , Belgium
Royal Alexandra Hospital
Edmonton Alberta, T5H 3, Canada
Queen Elizabeth II Health Science Centre
Halifax Nova Scotia, B3H 3, Canada
York PCI Research
Newmarket Ontario, L3Y 2, Canada
St. Michael's Hospital
Toronto Ontario, M5B-1, Canada
Montreal Heart Institute
Montreal , QC H1, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Quebec , 3840, Canada
Centre Hospitalier Universitaire de Sherbrooke
Quebec , J1H 5, Canada
Hopital de Brive Service de Cardiologie
Brive la Gaillarde , 19312, France
Hopital Henri Mondor
Creteil Cedex , 94010, France
Hopital du Bocage Central
Dijon Cedex , 21079, France
CHU Grenoble - Hopital Michallon
Grenoble Cedex 09 , , France
Centre Hospitalier Regional Universitaire de Lille
Lille , 59037, France
Centre Hospitalier Universitaire de Nice Hopital Pasteur
Nice Cedex 1 , 06002, France
Hopital Lariboisiere
Paris , 75010, France
Nouvel Hopital Civil
Strasbourg Cedex , 67091, France
CHU de Toulouse - Hopital Rangueil
Toulouse , 31059, France
Vivantes Netzwerk fur Gesundheit GmbH, Kinikum Neukolln
Berlin , 12351, Germany
Vivantes Humboldt-Klinikum
Berlin , 13509, Germany
Helios Klinikum Erfurt
Erfurt , 99089, Germany
Elisabeth-Krankenhaus
Essen , 45138, Germany
Universitatsklinikum Heidelberg
Heidelberg , 69120, Germany
Universitatsklinikum Jena, Klinik fur Innere Medizin, Kardiologie
Jena , 07747, Germany
Klinik fur Kardiologie and Angiologie Universitatsklinikum
Kiel , 24105, Germany
University of Leipzig
Leipzig , D-042, Germany
Universitatsklinikum Schleswig-Holstein
Lubeck , 23538, Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen , D-670, Germany
Universitatsmedizin Mannheim
Mannheim , D-681, Germany
Klinikum der Universitat Munchen LMU
Munchen , 81377, Germany
Stadtische Kliniken Neuss - Lukaskrankenhaus
Neuss , 41464, Germany
Klinikum Oldenburg gGmbH
Oldenburg , 26133, Germany
St. Marien-Krankenhaus Siegen gem. GMbH
Siegen , 57072, Germany
Krankenhaus Barmherzige Brüder Abt.Kardiologie und Pneumologie
Trier , 54292, Germany
Helios Klinikum Wuppertal
Wuppertal , 42117, Germany
The Edith Wolfson Medical Center
Holon Tel Aviv, 58100, Israel
HaEmek Medical Center
Afula , 18101, Israel
Barzilai Medical Center
Ashkelon , 78278, Israel
Rambam Medical Center
Haifa , 31096, Israel
The Lady Davis Carmel Medical Center
Haifa , 34362, Israel
B'nai Zion Medical Center
Haifa , , Israel
Hadassah University Medical Center Jerusalem-Cardiology
Jerusalem , 91120, Israel
Kaplan Medical Center
Rehovot , , Israel
Sheba Medical Center - Tel Hashomer
Tel Hashomer , 52621, Israel
UCK, Kliniczne Centrum Kardiologii
Gdańsk , 80-95, Poland
Centrum Interwencyjnego Leczenia Chorob Serca i Naczyn z Pododdzialem Kardiologii Interwencyjnej
Krakow , 31-20, Poland
I Klinika Kardiologii i Elektrokardiologii lnterwencyjnej oraz Nadcisnienia Tetniczego CM UJ
Kraków , 31-50, Poland
Oddzial Kardiologiczny Wojewodzki Specjalistyczny Szpital im. Bieganskiego w Lodzi
Lodz , 91-34, Poland
Samodzileny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin , 20-95, Poland
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM w Szczecinie
Szczecin , 70-11, Poland
Pracownia Kardiologii Inwazyjnej
Warsaw , 02-09, Poland
Cetrainy Szpital Kliniczny MSWIA
Warszawa , 02-50, Poland
Hospital del Mar/Passeig Maritim 25-29
Barcelona , 08003, Spain
Hospital Juan Ramon Jimenez
Huelva , 21005, Spain
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital Clinico de Santiago de Compostela
Santiago , 15706, Spain

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

303

Study ID:

NCT01226563

Recruitment Status:

Completed

Sponsor:


Bellerophon BCM LLC

How clear is this clinincal trial information?

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