MPP Programming Study
Evaluation of Programming Strategies for MultiPoint™ Pacing in Cardiac Resynchronization Therapy Patients
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable heart-failure
Started May 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 14, 2013
CompletedFirst Posted
Study publicly available on registry
May 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedFebruary 4, 2019
February 1, 2019
1.6 years
May 14, 2013
February 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
end-systolic volume
6 months
Study Arms (2)
MultiPoint Pacing programming based on hemodynamics
ACTIVE COMPARATORCRT device implant with MultiPoint Pacing Hemodynamic measurements for CRT device programming
MultiPoint Pacing programming without hemodynamics
EXPERIMENTALCRT device implant with MultiPoint Pacing CRT device programming without hemodynamics
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maria Cecilia Hospital, GVM Care & Research
Cotignola, RA, 48010, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlo Pappone, MD, PhD
Maria Cecilia Hospital, GVM Care & Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2013
First Posted
May 17, 2013
Study Start
May 1, 2013
Primary Completion
December 1, 2014
Study Completion
February 1, 2015
Last Updated
February 4, 2019
Record last verified: 2019-02