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MPP Programming Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01856725
Recruitment Status : Completed
First Posted : May 17, 2013
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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.

Condition or disease Intervention/treatment Phase
Heart Failure Procedure: Hemodynamic measurements for CRT device programming Device: CRT device implant with MultiPoint Pacing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Programming Strategies for MultiPoint™ Pacing in Cardiac Resynchronization Therapy Patients
Study Start Date : May 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : February 2015

Arm Intervention/treatment
Active Comparator: MultiPoint Pacing programming based on hemodynamics

CRT device implant with MultiPoint Pacing

Hemodynamic measurements for CRT device programming

Procedure: Hemodynamic measurements for CRT device programming
Device: CRT device implant with MultiPoint Pacing
Experimental: MultiPoint Pacing programming without hemodynamics

CRT device implant with MultiPoint Pacing

CRT device programming without hemodynamics

Device: CRT device implant with MultiPoint Pacing



Primary Outcome Measures :
  1. end-systolic volume [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856725


Locations
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Italy
Maria Cecilia Hospital, GVM Care & Research
Cotignola, RA, Italy, 48010
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Carlo Pappone, MD, PhD Maria Cecilia Hospital, GVM Care & Research
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01856725    
Other Study ID Numbers: CRD_684
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases