NCT00964938

Brief Summary

The purpose of this study is to evaluate the effects of multisite left ventricular (LV) biventricular (BiV) pacing on LV hemodynamics in CRT patients. It is hypothesized that the effect of simultaneous BiV pacing utilizing multisite LV pacing on LV hemodynamics will be superior to conventional BiV pacing.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_4 heart-failure

Geographic Reach
1 country

1 active site

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

May 25, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

1.7 years

First QC Date

May 25, 2009

Last Update Submit

February 1, 2019

Conditions

Heart Failure

Keywords

Hemodynamic responseCardiac resynchronization therapy

Outcome Measures

Primary Outcomes (1)

  • dP/dt max

    acute: during implant procedure; 1 day

Interventions

Quadripolar LV lead (pacing configurations)DEVICE

Quadripolar LV lead will be used to deliver a combination of pacing configurations

Eligibility Criteria

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

You may qualify if:

  • Have a scheduled CRT implantation at the participating clinical study site
  • Have NYHA functional class III or IV, ejection fraction less than or equal to 35%, and QRS duration greater than 120ms
  • Be undergoing a new St. Jude Medical CRT-D device system (including LV lead) implantation
  • Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed perioperative evaluations

You may not qualify if:

  • Have persistent or permanent atrial fibrillation
  • Have an intrinsic heart rate of \<50 beats per minute
  • 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
  • Have had a recent CVA or TIA within 3 months prior to enrollment
  • Have had intravenous inotropic support in the last 30 days
  • Have ischemic etiology and are unable to tolerate stress echocardiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, Canada

Location

Related Publications (1)

  • Thibault B, Dubuc M, Khairy P, Guerra PG, Macle L, Rivard L, Roy D, Talajic M, Karst E, Ryu K, Paiement P, Farazi TG. Acute haemodynamic comparison of multisite and biventricular pacing with a quadripolar left ventricular lead. Europace. 2013 Jul;15(7):984-91. doi: 10.1093/europace/eus435. Epub 2013 Feb 27.

    PMID: 23447571DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • B Thibault

    Montreal Heart

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2009

First Posted

August 25, 2009

Study Start

August 1, 2009

Primary Completion

April 1, 2011

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

CA(1)