MultiPoint Pacing Programming Guided by Noninvasive Hemodynamics

January 31, 2019 updated by: Abbott Medical Devices

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Medizinische Universität Graz
  • France
      • Rennes, France
        • CHU Rennes
  • Italy
      • Milan, Italy
        • Niguarda Hospital
      • Pavia, Italy
        • Fondazione IRCCS Policlinico San Matteo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MultiPoint Pacing
CRT with MultiPoint Pacing
Device: CRT with MultiPoint Pacing
Procedure: Hemodynamic measurements for CRT device programming

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Systolic blood pressure changes in hemodynamics during BiV pacing and MPP
Time Frame: up to 6-months
up to 6-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Christophe Leclercq, MD, PhD, University Hospital Rennes, Rennes, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

February 14, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimate)

February 17, 2014

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD_704

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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