MultiPoint Pacing IDE Study
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/6/2019 |
Start Date: | April 2013 |
End Date: | June 2016 |
This IDE study is a prospective, randomized, double-blind, multi-center clinical study to
evaluate the safety and efficacy of patient treatment with MPP compared to patient treatment
with standard BiV pacing at 9 months.
The study will be conducted at a maximum of 50 investigational centers located in the United
States. A maximum of 506 subjects implanted with the Quadripolar cardiac resynchronization
therapy device (CRT-D) system will be enrolled in the study.
evaluate the safety and efficacy of patient treatment with MPP compared to patient treatment
with standard BiV pacing at 9 months.
The study will be conducted at a maximum of 50 investigational centers located in the United
States. A maximum of 506 subjects implanted with the Quadripolar cardiac resynchronization
therapy device (CRT-D) system will be enrolled in the study.
All subjects will undergo a 2 dimensional Echocardiogram within the 30 days prior to implant,
and again at 3, 6 and 9 months post implant. At implant, the final LV pacing configuration is
programmed using any one of the 10 available pacing vectors. The paced/sensed
atrioventricular (AV) and interventricular (VV) delays may be optimized as per the site's
standard of care. Subjects will continue to receive BiV therapy until the 3-month follow-up
visit.
At the 3-month visit, responder status between Enrollment and 3 months will be assessed using
the Clinical Composite Score (CCS). All subjects that are "Improved" using the definition
outlined in the CCS will be grouped together as Responders. All subjects that are "Worsened"
or "Unchanged" using the definitions outlined in the CCS will be considered as
Non-responders. All subjects will undergo acute measurement of cardiac performance (e.g.,
Echocardiography) at various MPP combinations compared to BiV pacing. Only subjects with
"equal or better" echocardiographic measurements (i.e., EA VTI measurements) with MPP feature
on compared to BiV pacing will be randomized in a 1:1 ratio to one of the two arms - BiV arm
or MPP arm.
At the 9-month visit, responder status will be evaluated once again using the CCS and
compared to the status at 3 months.
and again at 3, 6 and 9 months post implant. At implant, the final LV pacing configuration is
programmed using any one of the 10 available pacing vectors. The paced/sensed
atrioventricular (AV) and interventricular (VV) delays may be optimized as per the site's
standard of care. Subjects will continue to receive BiV therapy until the 3-month follow-up
visit.
At the 3-month visit, responder status between Enrollment and 3 months will be assessed using
the Clinical Composite Score (CCS). All subjects that are "Improved" using the definition
outlined in the CCS will be grouped together as Responders. All subjects that are "Worsened"
or "Unchanged" using the definitions outlined in the CCS will be considered as
Non-responders. All subjects will undergo acute measurement of cardiac performance (e.g.,
Echocardiography) at various MPP combinations compared to BiV pacing. Only subjects with
"equal or better" echocardiographic measurements (i.e., EA VTI measurements) with MPP feature
on compared to BiV pacing will be randomized in a 1:1 ratio to one of the two arms - BiV arm
or MPP arm.
At the 9-month visit, responder status will be evaluated once again using the CCS and
compared to the status at 3 months.
Inclusion Criteria:
- Meets current clinical indication for implantation of a cardiac resynchronization
therapy system for treatment of heart failure or life-threatening ventricular
tachyarrhythmia(s)
- Receiving a new CRT implant or undergoing an upgrade from an existing ICD or pacemaker
implant with no prior LV 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:
- Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA)
within 3 months of enrollment
- Have an existing Class I recalled lead
- Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
- Have a classification of Status 1 for cardiac transplantation or consideration for
transplantation over the next 9 months
- Have permanent atrial fibrillation (AF)
- Have undergone a cardiac transplantation within 40 days of enrollment
- Have had a recent myocardial infarction, unstable angina within 40 days or cardiac
revascularization within 3 months of implant.
- Are currently participating in a clinical investigation that includes an active
treatment arm
- Are pregnant or planning to become pregnant during the duration of the study
- Have a life expectancy of less than 9 months due to any condition
- Are less than 18 years of age
We found this trial at
49
sites
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
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Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
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Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Sarasota Memorial Hospital Sarasota Memorial Health Care System, an 806-bed regional medical center, is among...
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Toledo Hospital ProMedica’s Mission is to improve your health and well-being. And we at ProMedica...
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