MPP Programming Study
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Hemodynamic measurements for CRT device programming
CRT device implant with MultiPoint Pacing
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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.
Sites / Locations
- Maria Cecilia Hospital, GVM Care & Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
MultiPoint Pacing programming based on hemodynamics
MultiPoint Pacing programming without hemodynamics
Arm Description
CRT device implant with MultiPoint Pacing Hemodynamic measurements for CRT device programming
CRT device implant with MultiPoint Pacing CRT device programming without hemodynamics
Outcomes
Primary Outcome Measures
end-systolic volume
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01856725
Brief Title
MPP Programming Study
Official Title
Evaluation of Programming Strategies for MultiPoint™ Pacing in Cardiac Resynchronization Therapy Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the efficacy of cardiac resynchronization therapy (CRT) device programming with hemodynamic measurements to device programming without hemodynamic measurements.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MultiPoint Pacing programming based on hemodynamics
Arm Type
Active Comparator
Arm Description
CRT device implant with MultiPoint Pacing
Hemodynamic measurements for CRT device programming
Arm Title
MultiPoint Pacing programming without hemodynamics
Arm Type
Experimental
Arm Description
CRT device implant with MultiPoint Pacing
CRT device programming without hemodynamics
Intervention Type
Procedure
Intervention Name(s)
Hemodynamic measurements for CRT device programming
Intervention Type
Device
Intervention Name(s)
CRT device implant with MultiPoint Pacing
Primary Outcome Measure Information:
Title
end-systolic volume
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Pappone, MD, PhD
Organizational Affiliation
Maria Cecilia Hospital, GVM Care & Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maria Cecilia Hospital, GVM Care & Research
City
Cotignola
State/Province
RA
ZIP/Postal Code
48010
Country
Italy
12. IPD Sharing Statement
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MPP Programming Study
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