Phase
Condition
Heart Defect
Heart Disease
Congestive Heart Failure
Treatment
mavacamten
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Has completed the Parent Study through to the EOS Visit within 90 days of consent. (Participants who are beyond the 90-day window from EOS Visit may be included inthis study pending MyoKardia Medical Monitoring approval) Participants whoprematurely discontinued from the Parent Study or the MAVA-LTE study may beconsidered for inclusion.
Has a body weight greater than 45 kg at the Screening Visit
Has adequate acoustic windows to enable accurate TTEs.
Has documented LVEF ≥ 50% by echocardiography core laboratory read of screening TTEat rest.
Has safety laboratory parameters (chemistry, hematology, coagulation, andurinalysis) within normal limits (according to the central laboratory referencerange).
Female participants must not be pregnant or lactating and, if sexually active, mustuse one of the following highly effective birth control methods from the ScreeningVisit through 90 days after the last dose of investigational medicinal product (IMP).
In addition to the above contraceptive requirements for female participants, male partners must also use a contraceptive (eg. barrier, condom, or vasectomy).
Exclusion
Key Exclusion Criteria:
Has any ECG abnormality considered by the investigator to pose a risk to participantsafety (eg. second degree atrioventricular block type II).
Has a history of syncope or a history of sustained ventricular tachyarrhythmia withexercise between Parent Study EOS Visit and Screening Visit.
Has a history of resuscitated sudden cardiac arrest or known history of appropriateimplantable cardioverter-defibrillator (ICD) discharge for life-threateningventricular arrhythmia between Parent Study EOS Visit and Screening Visit. (Note:history of anti-tachycardia pacing (ATP) is allowed).• Currently treated withdisopyramide or ranolazine (within 14 days prior to Screening) or treatment withdisopyramide or ranolazine is planned during the study.
Has any acute or serious comorbid condition (eg. major infection or hematologic,renal, metabolic, gastrointestinal, or endocrine dysfunction) that, in the judgmentof the Investigator, could lead to premature termination of study participation orinterfere with the measurement or interpretation of the efficacy and safetyassessments in the study.
History of clinically significant malignant disease that developed since enrollmentin the Parent Study.
Is unable to comply with the study requirements, including the number of requiredvisits to the clinical site.
Has participated in a clinical trial in which the participant received anyinvestigational drug (or is currently using an investigational device) within 30days prior to Screening, or at least 5 times the respective elimination half-life (whichever is longer), except for participation in MAVERICK-HCM or EXPLORER-HCM.Prior participation in a non-interventional observational study is allowed.
Study Design
Connect with a study center
Local Institution - 0002
Aalst, 9300
BelgiumSite Not Available
Local Institution - 0002
Aalst 2803448, 9300
BelgiumSite Not Available
Local Institution - 0001
Brussels, 1070
BelgiumSite Not Available
Local Institution - 0001
Brussels 2800866, 1070
BelgiumSite Not Available
Hôpital Erasme
Bruxelles, 1070
BelgiumSite Not Available
Local Institution - 0003
Edegem, 2650
BelgiumSite Not Available
Local Institution - 0003
Edegem 2799007, 2650
BelgiumSite Not Available
Local Institution - 0009
Prague, 140 21
CzechiaSite Not Available
Local Institution - 0009
Prague 3067696, 140 21
CzechiaSite Not Available
Local Institution - 0010
Prague 3067696, 128 08
CzechiaSite Not Available
Local Institution - 0010
Praha 2, 128 08
CzechiaSite Not Available
Institut klinicke a experimentalni mediciny
Praha 4, 140 21
CzechiaSite Not Available
Local Institution - 0011
Aarhus, 8000
DenmarkSite Not Available
Local Institution - 0011
Aarhus 2624652, 8000
DenmarkSite Not Available
Aarhus Universitetshospital
Aarhus N, 8200
DenmarkSite Not Available
Local Institution - 0012
Frederiksberg, 2000
DenmarkSite Not Available
Local Institution - 0012
Frederiksberg 2621942, 2000
DenmarkSite Not Available
Local Institution - 0013
Odense, 5000
DenmarkSite Not Available
Local Institution - 0013
Odense 2615876, 5000
DenmarkSite Not Available
Local Institution - 0014
Nantes, 44093
FranceSite Not Available
Local Institution - 0014
Nantes 2990969, 44093
FranceSite Not Available
CHRU Nantes
Nantes Cedex 1, 44093
FranceSite Not Available
Local Institution - 0016
Paris, 75015
FranceSite Not Available
Local Institution - 0017
Paris, 75013
FranceSite Not Available
Local Institution - 0016
Paris 2988507, 75015
FranceSite Not Available
Local Institution - 0017
Paris 2988507, 75013
FranceSite Not Available
Local Institution - 0015
Toulouse, 31059
FranceSite Not Available
Local Institution - 0015
Toulouse 2972315, 31059
FranceSite Not Available
University Medicine Göttingen Germany
Göttingen, Niedersachsen 37075
GermanySite Not Available
Local Institution - 0020
Bad Nauheim, 61231
GermanySite Not Available
Local Institution - 0020
Bad Nauheim 2953395, 61231
GermanySite Not Available
Local Institution - 0018
Dresden, 01277
GermanySite Not Available
Local Institution - 0018
Dresden 2935022, 01277
GermanySite Not Available
Local Institution - 0019
Goettingen, 37075
GermanySite Not Available
Local Institution - 0019
Göttingen 2918632, 37075
GermanySite Not Available
Local Institution - 0021
Heidelberg, 69120
GermanySite Not Available
Local Institution - 0021
Heidelberg 2907911, 69120
GermanySite Not Available
Local Institution - 0027
Jerusalem, 9112001
IsraelSite Not Available
Local Institution - 0027
Jerusalem 281184, 9112001
IsraelSite Not Available
Local Institution - 0024
Petah Tikva, 4941492
IsraelSite Not Available
Local Institution - 0024
Petah Tikva 293918, 4941492
IsraelSite Not Available
Sheba Medical Center - PPDS
Ramat Gan, 52621
IsraelSite Not Available
Local Institution - 0022
Ramat Gan 293788, 52621
IsraelSite Not Available
Local Institution - 0022
Ramat-gan, 52621
IsraelSite Not Available
Local Institution - 0025
Rehovot, 76100
IsraelSite Not Available
Local Institution - 0025
Rehovot 293725, 76100
IsraelSite Not Available
Local Institution - 0023
Safed, 13100
IsraelSite Not Available
Local Institution - 0023
Safed 293100, 13100
IsraelSite Not Available
Local Institution - 0026
Tel Aviv, 6423906
IsraelSite Not Available
Local Institution - 0026
Tel Aviv 293397, 6423906
IsraelSite Not Available
Tel Aviv Sourasky Medical Center PPDS
Tel-Aviv, 64239
IsraelSite Not Available
Local Institution - 0028
Firenze, 50139
ItalySite Not Available
Azienda Ospedaliera Universitaria Careggi
Florence,
ItalySite Not Available
Local Institution - 0028
Florence 3176959, 50139
ItalySite Not Available
Local Institution - 0029
Maastricht, 6229 HX
NetherlandsSite Not Available
Local Institution - 0029
Maastricht 2751283, 6229 HX
NetherlandsSite Not Available
Local Institution - 0030
Rotterdam, 3015 CE
NetherlandsSite Not Available
Local Institution - 0030
Rotterdam 2747891, 3015 CE
NetherlandsSite Not Available
Collegium Medicum Uniwersytetu Jagiellonskiego
Kraków, Malopolskie 31-501
PolandSite Not Available
Szpital Kliniczny Przemienienia Panskiego Uniwesytetu Medycznego im. Karola Marcinkowskiego
Poznań, Wielkopolskie 61-848
PolandSite Not Available
Local Institution - 0033
Katowice, 40-555
PolandSite Not Available
Local Institution - 0033
Katowice 3096472, 40-555
PolandSite Not Available
Local Institution - 0034
Krakow, 31-501
PolandSite Not Available
Local Institution - 0034
Krakow 3094802, 31-501
PolandSite Not Available
Local Institution - 0031
Poznan, 61-848
PolandSite Not Available
Local Institution - 0031
Poznan 3088171, 61-848
PolandSite Not Available
Local Institution - 0032
Warsaw, 04-628
PolandSite Not Available
Local Institution - 0032
Warsaw 756135, 04-628
PolandSite Not Available
Local Institution - 0036
Almada, 2805-267
PortugalSite Not Available
Local Institution - 0036
Almada 2271961, 2805-267
PortugalSite Not Available
Local Institution - 0035
Lisboa, 1500-650
PortugalSite Not Available
Local Institution - 0035
Lisbon 2267057, 1500-650
PortugalSite Not Available
Local Institution - 0038
A Coruña, 15006
SpainSite Not Available
Local Institution - 0038
A Coruña 3119841, 15006
SpainSite Not Available
Local Institution - 0037
El Palmar, 30120
SpainSite Not Available
Local Institution - 0037
El Palmar 2518293, 30120
SpainSite Not Available
Local Institution - 0040
Madrid, 28034
SpainSite Not Available
Local Institution - 0040
Madrid 3117735, 28034
SpainSite Not Available
Local Institution - 0039
Majadahonda, 28222
SpainSite Not Available
Local Institution - 0039
Majadahonda 3117667, 28222
SpainSite Not Available
Local Institution - 0041
Sevilla, 41009
SpainSite Not Available
Local Institution - 0041
Seville 2510911, 41009
SpainSite Not Available
Local Institution - 0042
London, W1G 8PH
United KingdomSite Not Available
Local Institution - 0042
London 2643743, W1G 8PH
United KingdomSite Not Available
Mayo Clinic Arizona
Phoenix, Arizona 85054
United StatesSite Not Available
Local Institution - 0045
Scottsdale, Arizona 85259
United StatesSite Not Available
Local Institution - 0045
Scottsdale 5313457, Arizona 5551752 85259
United StatesSite Not Available
Local Institution - 0058
Los Angeles, California 90027
United StatesSite Not Available
Local Institution - 0066
San Francisco, California 94143
United StatesSite Not Available
Local Institution - 0063
Stanford, California 94305
United StatesSite Not Available
Local Institution - 0058
Los Angeles 5368361, California 5332921 90027
United StatesSite Not Available
Local Institution - 0066
San Francisco 5391959, California 5332921 94143
United StatesSite Not Available
Local Institution - 0063
Stanford 5398563, California 5332921 94305
United StatesSite Not Available
Local Institution - 0043
New Haven, Connecticut 06520-8017
United StatesSite Not Available
Local Institution - 0043
New Haven 4839366, Connecticut 4831725 06520-8017
United StatesSite Not Available
Local Institution - 0067
Jacksonville, Florida 32224
United StatesSite Not Available
Local Institution - 0067
Jacksonville 4160021, Florida 4155751 32224
United StatesSite Not Available
Local Institution - 0050
Chicago, Illinois 60611
United StatesSite Not Available
Local Institution - 0050
Chicago 4887398, Illinois 4896861 60611
United StatesSite Not Available
Local Institution - 0070
Indianapolis, Indiana 46260
United StatesSite Not Available
Local Institution - 0070
Indianapolis 4259418, Indiana 4921868 46260
United StatesSite Not Available
Local Institution - 0049
Iowa City, Iowa 52242
United StatesSite Not Available
Local Institution - 0049
Iowa City 4862034, Iowa 4862182 52242
United StatesSite Not Available
Local Institution - 0054
Boston, Massachusetts 02115
United StatesSite Not Available
Local Institution - 0054
Boston 4930956, Massachusetts 6254926 02115
United StatesSite Not Available
Local Institution - 0051
Ann Arbor, Michigan 48109
United StatesSite Not Available
Local Institution
Detroit, Michigan 48202
United StatesSite Not Available
Local Institution - 0074
Grand Rapids, Michigan 49503
United StatesSite Not Available
Local Institution - 0051
Ann Arbor 4984247, Michigan 5001836 48109
United StatesSite Not Available
Local Institution - 0074
Grand Rapids 4994358, Michigan 5001836 49503
United StatesSite Not Available
Local Institution - 0048
Saint Louis, Missouri 63110
United StatesSite Not Available
Local Institution - 0048
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
Local Institution - 0056
New York, New York 10032
United StatesSite Not Available
Local Institution - 0060
New York, New York 10016
United StatesSite Not Available
Local Institution - 0056
New York 5128581, New York 5128638 10032
United StatesSite Not Available
Local Institution - 0060
New York 5128581, New York 5128638 10016
United StatesSite Not Available
Local Institution - 0071
Charlotte, North Carolina 28204
United StatesSite Not Available
Local Institution - 0047
Durham, North Carolina 27710
United StatesSite Not Available
Local Institution - 0071
Charlotte 4460243, North Carolina 4482348 28204
United StatesSite Not Available
Local Institution - 0047
Durham 4464368, North Carolina 4482348 27710
United StatesSite Not Available
Local Institution - 0052
Cincinnati, Ohio 45267
United StatesSite Not Available
Local Institution - 0052
Cincinnati 4508722, Ohio 5165418 45267
United StatesSite Not Available
Local Institution - 0044
Portland, Oregon 97239
United StatesSite Not Available
Local Institution - 0044
Portland 5746545, Oregon 5744337 97239
United StatesSite Not Available
Local Institution - 0068
Bethlehem, Pennsylvania 18015
United StatesSite Not Available
St. Luke's University Health Network
Danville, Pennsylvania 17822
United StatesSite Not Available
Local Institution - 0046
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Local Institution - 0064
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Local Institution - 0068
Bethlehem 5180225, Pennsylvania 6254927 18015
United StatesSite Not Available
Local Institution - 0046
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
Local Institution - 0064
Pittsburgh 5206379, Pennsylvania 6254927 15213
United StatesSite Not Available
Local Institution - 0073
Memphis, Tennessee 38104
United StatesSite Not Available
Local Institution - 0073
Memphis 4641239, Tennessee 4662168 38104
United StatesSite Not Available
Local Institution - 0061
Dallas, Texas 75390
United StatesSite Not Available
Local Institution - 0055
Houston, Texas 77030
United StatesSite Not Available
Local Institution - 0057
Houston, Texas 77030
United StatesSite Not Available
Local Institution - 0061
Dallas 4684888, Texas 4736286 75390
United StatesSite Not Available
Local Institution - 0055
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Local Institution - 0057
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Local Institution - 0072
Murray, Utah 84107-5701
United StatesSite Not Available
Local Institution - 0062
Salt Lake City, Utah 84112
United StatesSite Not Available
Local Institution - 0072
Murray 5778755, Utah 5549030 84107-5701
United StatesSite Not Available
Local Institution - 0062
Salt Lake City 5780993, Utah 5549030 84112
United StatesSite Not Available
Local Institution - 0053
Charlottesville, Virginia 22903
United StatesSite Not Available
Local Institution - 0059
Richmond, Virginia 23298
United StatesSite Not Available
Local Institution - 0053
Charlottesville 4752031, Virginia 6254928 22903
United StatesSite Not Available
Local Institution - 0059
Richmond 4781708, Virginia 6254928 23298
United StatesSite Not Available
Local Institution - 0065
Seattle, Washington 98195
United StatesSite Not Available
Local Institution - 0065
Seattle 5809844, Washington 5815135 98195
United StatesSite Not Available

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