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MultiPoint Pacing Programming Guided by Noninvasive Hemodynamics

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Abbott

Status

Completed

Conditions

Heart Failure

Treatments

Procedure: Hemodynamic measurements for CRT device programming
Device: CRT with MultiPoint Pacing

Study type

Interventional

Funder types

Industry

Identifiers

NCT02064751
CRD_704

Details and patient eligibility

About

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).

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

MultiPoint Pacing
Experimental group
Description:
CRT with MultiPoint Pacing
Treatment:
Device: CRT with MultiPoint Pacing
Procedure: Hemodynamic measurements for CRT device programming

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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