NCT02064751

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Mar 2014

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

2.2 years

First QC Date

February 14, 2014

Last Update Submit

January 31, 2019

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Systolic blood pressure changes in hemodynamics during BiV pacing and MPP

    up to 6-months

Secondary Outcomes (1)

  • echocardiographic changes to MPP programming guided by noninvasive hemodynamic measurements

    6 months

Study Arms (1)

MultiPoint Pacing

EXPERIMENTAL

CRT with MultiPoint Pacing

Device: CRT with MultiPoint PacingProcedure: Hemodynamic measurements for CRT device programming

Interventions

CRT with MultiPoint PacingDEVICE
MultiPoint Pacing
Hemodynamic measurements for CRT device programmingPROCEDURE
MultiPoint Pacing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Medizinische Universität Graz

Graz, Austria

Location

CHU Rennes

Rennes, France

Location

Niguarda Hospital

Milan, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Christophe Leclercq, MD, PhD

    University Hospital Rennes, Rennes, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2014

First Posted

February 17, 2014

Study Start

March 1, 2014

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

February 4, 2019

Record last verified: 2019-01

Locations

AU(1)FR(1)IT(2)