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Multisite Pacing With a Quadripolar Lead

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Quadripolar LV lead (pacing configurations)
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring Hemodynamic response, Cardiac resynchronization therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Montreal Heart Institute

Outcomes

Primary Outcome Measures

dP/dt max

Secondary Outcome Measures

Full Information

First Posted
May 25, 2009
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00964938
Brief Title
Multisite Pacing With a Quadripolar Lead
Official Title
Multisite Pacing With a Quadripolar Left Heart Lead in Cardiovascular Resynchronization Therapy (CRT) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Hemodynamic response, Cardiac resynchronization therapy

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Quadripolar LV lead (pacing configurations)
Intervention Description
Quadripolar LV lead will be used to deliver a combination of pacing configurations
Primary Outcome Measure Information:
Title
dP/dt max
Time Frame
acute: during implant procedure; 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
B Thibault
Organizational Affiliation
Montreal Heart
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23447571
Citation
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.
Results Reference
derived

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Multisite Pacing With a Quadripolar Lead

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