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OpenTrials
Completed

NCT Number: NCT02064751

MultiPoint Pacing Programming Guided by Noninvasive Hemodynamics

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).

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medizinische Universität Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CRT with MultiPoint Pacing

Device

Hemodynamic measurements for CRT device programming

Procedure

Primary outcomes

  1. Systolic blood pressure changes in hemodynamics during BiV pacing and MPP

    Time frame: up to 6-months

Secondary outcomes

  1. echocardiographic changes to MPP programming guided by noninvasive hemodynamic measurements

    Time frame: 6 months

    End systolic volume will be assessed at 6-month follow-up visit and compared to that of baseline.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 17, 2014
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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