Heart Failure Clinical Trial
MultiPoint Pacingâ„¢ Post Market Study
Summary
This is a prospective, multicenter, non-randomized registry/observational study. The study will enroll up to 2,000 patients with successful St. Jude Medical (SJM) Cardiac Resynchronization Therapy (CRT) MP device implant from up to 140 centers undergoing CRT implantation.
Full Description
Any patient who received a market approved SJM Quadra Allure MP, Quadra Assura MP, or newer SJM CRT MP device is eligible for enrollment in the study. MultiPoint Pacing (MPP) programming guidance will be specified in the protocol. Patients will be followed for 12 months after implant. Data will be collected at Baseline (within 30 days prior to implant), Post-Implant (within 30 days following successful CRT device implant), 3, 6, 12 months and during any unscheduled follow-up visit.
Eligibility Criteria
Inclusion Criteria:
Are scheduled to receive a new CRT implant or an upgrade from an existing implantable cardioverter defibrillator or pacemaker implant (SJM CRT MP device and SJM Quadripolar Lead) with no prior left ventricular lead placement
Have the ability to provide informed consent for study participation and are willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion Criteria:
Are expected to receive a heart transplant during the duration of the study
Have an epicardial ventricular lead system (Active or Inactive)
Are less than 18 years of age
Are currently participating in a clinical investigation including an active treatment arm and belong to the active arm
Are not expected to complete the study follow-up schedule or duration due to any health condition other than heart failure, such as malignancy, indication for heart transplant or hospice care
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There are 125 Locations for this study
Birmingham Alabama, 35249, United States
Huntsville Alabama, 35801, United States
Avondale Arizona, 85392, United States
Glendale Arizona, 85306, United States
Phoenix Arizona, 85013, United States
Phoenix Arizona, 85018, United States
Phoenix Arizona, 85020, United States
Scottsdale Arizona, 85251, United States
Alhambra California, 91801, United States
Los Angeles California, 90033, United States
Los Angeles California, 90048, United States
Newport Beach California, 92663, United States
Palm Springs California, 92262, United States
Pomona California, 91767, United States
Reseda California, 91335, United States
San Diego California, 92123, United States
Torrance California, 90505, United States
Aurora Colorado, 80012, United States
Norwalk Connecticut, 06851, United States
Boca Raton Florida, 33422, United States
Delray Beach Florida, 33484, United States
Hollywood Florida, 33021, United States
Inverness Florida, 34452, United States
Jacksonville Florida, 32204, United States
Kissimmee Florida, 34741, United States
Lake Mary Florida, 32746, United States
New Smyrna Beach Florida, 32168, United States
Orlando Florida, 32837, United States
Pensacola Florida, 32504, United States
Rockledge Florida, 32955, United States
Sarasota Florida, 34239, United States
Tampa Florida, 33612, United States
Athens Georgia, 30606, United States
Atlanta Georgia, 30342, United States
Macon Georgia, 31201, United States
Rome Georgia, 30165, United States
Hinsdale Illinois, 60521, United States
Oak Lawn Illinois, 60453, United States
Richmond Indiana, 47374, United States
Leawood Kansas, 66211, United States
Lexington Kentucky, 40503, United States
Louisville Kentucky, 40202, United States
Owensboro Kentucky, 42304, United States
Monroe Louisiana, 71201, United States
New Orleans Louisiana, 70121, United States
Shreveport Louisiana, 71103, United States
Shreveport Louisiana, 71130, United States
Bangor Maine, 04401, United States
Hyattsville Maryland, 20782, United States
Boston Massachusetts, 02118, United States
Fall River Massachusetts, 02720, United States
Ann Arbor Michigan, 48106, United States
Flushing Michigan, 48433, United States
Lansing Michigan, 48912, United States
Midland Michigan, 48670, United States
Saginaw Michigan, 48601, United States
Southfield Michigan, 48075, United States
Traverse City Michigan, 49684, United States
Jackson Mississippi, 39216, United States
Kansas City Missouri, 64111, United States
Saint Louis Missouri, 63131, United States
Saint Louis Missouri, 63136, United States
Kearney Nebraska, 68845, United States
Lincoln Nebraska, 68506, United States
Las Vegas Nevada, 89169, United States
Manchester New Hampshire, 03102, United States
Browns Mills New Jersey, 08015, United States
Morristown New Jersey, 07962, United States
Neptune New Jersey, 08015, United States
New Brunswick New Jersey, 08901, United States
Albuquerque New Mexico, 87106, United States
Albany New York, 12205, United States
Buffalo New York, 14215, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27705, United States
High Point North Carolina, 27262, United States
Cleveland Ohio, 44195, United States
Elyria Ohio, 44035, United States
Middletown Ohio, 45044, United States
Corvallis Oregon, 97330, United States
Portland Oregon, 97225, United States
Danville Pennsylvania, 17822, United States
Philadelphia Pennsylvania, 19104, United States
Scranton Pennsylvania, 18510, United States
Yardley Pennsylvania, 19067, United States
Florence South Carolina, 29506, United States
Greenville South Carolina, 29601, United States
Lexington South Carolina, 29204, United States
Johnson City Tennessee, 37601, United States
Kingsport Tennessee, 37660, United States
Memphis Tennessee, 38104, United States
Austin Texas, 78756, United States
Bedford Texas, 76021, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
San Antonio Texas, 78201, United States
San Antonio Texas, 78229, United States
Wichita Falls Texas, 76301, United States
Ogden Utah, 84403, United States
Salt Lake City Utah, 84132, United States
Charlottesville Virginia, 22908, United States
Falls Church Virginia, 22042, United States
Falls Church Virginia, 22042, United States
Virginia Beach Virginia, 23454, United States
Spokane Washington, 92204, United States
Huntington West Virginia, 25702, United States
La Crosse Wisconsin, 54601, United States
Wausau Wisconsin, 54401, United States
Wauwatosa Wisconsin, 53226, United States
Caba Buenos Aires, C1122, Argentina
Buenos Aires Rio De La Plata, C1093, Argentina
Buenos Aires Rio De La Plata, C1428, Argentina
Bogota Antioquia, 11011, Colombia
Medellin Antioquia, 1104, Colombia
Hirosaki Aomori, 03682, Japan
Kitakyushu Fukuoka, 80200, Japan
Hyogo Kinki, 67400, Japan
Sendai Miyagi, 98085, Japan
Shinjuku-Ku Tokyo, 16286, Japan
Chiba , 26086, Japan
Kanagawa , 21685, Japan
Matsumoto , 39086, Japan
Niigata , 95185, Japan
Osaka , 53000, Japan
Osaka , 56585, Japan
Osaka , 65608, Japan
Tsukuba , 30585, Japan
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