MultiPoint Pacing Programming Guided by Noninvasive Hemod... | NCT02064751

Studies
MultiPoint Pacing Programming Guided by Noninvasive Hemodynamics

NCT02064751

Sponsor

Abbott Medical Devices

Status

Completed

Last Update Posted

Feb 4, 2019Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Heart Failure

Interventions

CRT with MultiPoint Pacing
Hemodynamic measurements for CRT device programming

Countries

Austria
France
Italy

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

Jan 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

Mar 2014

Primary Completion Date

May 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Feb 14, 2014

First Submission Date that Met QC Criteria

Feb 14, 2014

First Posted Date

Feb 17, 2014Estimated

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

Jan 31, 2019

Last Update Posted Date

Feb 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 noninvasive hemodynamics with MultiPoint™ Pacing (MPP) and biventricular (BiV) pacing under various vector combinations and paced delays in patients receiving cardiac resynchronization therapy (CRT).

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MultiPoint Pacing	Experimental	CRT with MultiPoint Pacing	Device: CRT with MultiPoint Pacing Procedure: Hemodynamic measurements for CRT device programming

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CRT with MultiPoint Pacing	Device		MultiPoint Pacing
Hemodynamic measurements for CRT device programming

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
echocardiographic changes to MPP programming guided by noninvasive hemodynamic measurements	End systolic volume will be assessed at 6-month follow-up visit and compared to that of baseline.	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christophe Leclercq, MD, PhD	University Hospital Rennes, Rennes, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medizinische Universität Graz		Graz			Austria
CHU Rennes

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases