MultiPoint Pacing™ Post Market Study
Status: | Active, not recruiting |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/3/2019 |
Start Date: | July 2016 |
End Date: | June 2020 |
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.
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.
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.
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.
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
We found this trial at
111
sites
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Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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Emory University Hospital As the largest health care system in Georgia and the only health...
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Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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3600 Northwest Samaritan Drive
Corvallis, Oregon 97330
Corvallis, Oregon 97330
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Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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Advocate Christ Medical Center Advocate Health Care, named among the nation
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Providence St. Vincent Medical Center Providence St. Vincent is renowned for its many centers of...
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Missouri Baptist Medical Center You just feel it. The smile that greets you. The hand...
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Sarasota Memorial Hospital Sarasota Memorial Health Care System, an 806-bed regional medical center, is among...
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