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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01856725 |
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Date of registration:
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14/05/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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MPP Programming Study
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Scientific title:
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Evaluation of Programming Strategies for MultiPoint™ Pacing in Cardiac Resynchronization Therapy Patients |
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Date of first enrolment:
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May 2013 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01856725 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Carlo Pappone, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Maria Cecilia Hospital, GVM Care & Research |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Be scheduled to undergo implant of a St. Jude Medical (SJM) CRT-D system with approved
standard indication by ESC/EHRA Guidelines
- Have the ability to provide informed consent for study participation and be willing
and able to comply with the Clinical Investigation Plan (CIP) described evaluations
and follow-up schedule
Exclusion Criteria:
- Have high ventricular rate (>90 bpm) during persistent or permanent atrial
fibrillation despite available treatment
- Be in NYHA IV functional class
- Have a recent myocardial infarction within 40 days prior to enrollment
- Have undergone cardiac bypass surgery or coronary revascularization procedure within 3
months prior to enrollment or be scheduled for such procedures in the following 7
months
- Have had a recent CVA or TIA within 3 months prior to enrollment
- Have had intravenous inotropic support in the last 30 days
- Be less than 18 years of age
- Be pregnant or planning to become pregnant during the duration of the investigation.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Heart Failure
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Intervention(s)
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Device: CRT device implant with MultiPoint Pacing
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Procedure: Hemodynamic measurements for CRT device programming
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Primary Outcome(s)
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end-systolic volume
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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