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Clinical Trials/NCT02064751
NCT02064751CompletedNot Applicable

Noninvasive Hemodynamics for MultiPoint(TM) Pacing Programming in Cardiac Resynchronization Therapy Patients

Abbott Medical Devices4 sites in 3 countries40 target enrollmentStarted: March 1, 2014Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
4
Primary Endpoint
Systolic blood pressure changes in hemodynamics during BiV pacing and MPP
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to evaluate noninvasive hemodynamics with MultiPoint™ Pacing (MPP) and biventricular (BiV) pacing under various vector combinations and paced delays in patients receiving cardiac resynchronization therapy (CRT).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Be scheduled to undergo de novo implant of a St. Jude Medical CRT-D system
  • •Be in NYHA II or III functional class 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 persistent or permanent atrial fibrillation
  • •Have a recent myocardial infarction within 40 days prior to enrollment
  • •Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 12 months
  • •Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months prior to enrollment
  • •Have had intravenous inotropic support in the last 30 days
  • •Be scheduled or considered for heart transplantation over the next 12 months
  • •Be less than 18 years of age
  • •Be pregnant or plan to become pregnant over the next 12 months

Arms & Interventions

MultiPoint Pacing

Experimental

CRT with MultiPoint Pacing

Intervention: CRT with MultiPoint Pacing (Device)

MultiPoint Pacing

Experimental

CRT with MultiPoint Pacing

Intervention: Hemodynamic measurements for CRT device programming (Procedure)

Outcomes

Primary Outcomes

Systolic blood pressure changes in hemodynamics during BiV pacing and MPP

Time Frame: up to 6-months

Secondary Outcomes

  • echocardiographic changes to MPP programming guided by noninvasive hemodynamic measurements(6 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

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