Multisite Pacing With a Quadripolar Lead | NCT00964938

Studies
Multisite Pacing With a Quadripolar Lead

NCT00964938

Sponsor

Abbott Medical Devices

Status

Completed

Last Update Posted

Feb 4, 2019Actual

Enrollment

35Actual

Phase

Phase 4

Conditions

Heart Failure

Interventions

Quadripolar LV lead (pacing configurations)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Apr 2011Actual

Completion Date

Not provided

First Submitted Date

May 25, 2009

First Submission Date that Met QC Criteria

Aug 24, 2009

First Posted Date

Aug 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2019

Last Update Posted Date

Feb 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Quadripolar LV lead (pacing configurations)	Device	Quadripolar LV lead will be used to deliver a combination of pacing configurations

Measure	Description	Time Frame
dP/dt max		acute: during implant procedure; 1 day

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
B Thibault	Montreal Heart	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Montreal Heart Institute		Montreal	Quebec		Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23447571	Derived	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.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases