LEft Atrial Pacing in Diastolic Heart Failure | NCT01618981

Studies
LEft Atrial Pacing in Diastolic Heart Failure

NCT01618981

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

Dec 27, 2018Actual

Enrollment

Not provided

Phase

Not Applicable

Conditions

Heart Failure With Preserved Ejection Fraction
Atrial Dyssynchrony Syndrome
Left Atrio-ventricular Asynchrony

Interventions

pace make active/inactive cross over

Countries

France

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

Dec 2018

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

Nov 2012Actual

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Jun 7, 2012

First Submission Date that Met QC Criteria

Jun 13, 2012

First Posted Date

Jun 14, 2012Estimated

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

Dec 26, 2018

Last Update Posted Date

Dec 27, 2018Actual

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 assess left atrial pacing therapy in patients with atrial dyssynchrony syndrome and heart failure with preserved ejection fraction.

Detailed Description

Not provided

Conditions Module

Conditions

Heart Failure With Preserved Ejection Fraction
Atrial Dyssynchrony Syndrome
Left Atrio-ventricular Asynchrony

Keywords

Heart failure with preserved ejection fraction
atrial dyssynchrony syndrome
left atrio-ventricular asynchrony
pacemaker
left atrial pacing therapy

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
first active	Experimental		Procedure: pace make active/inactive cross over
first inactive	Experimental		Procedure: pace make active/inactive cross over

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pace make active/inactive cross over	Procedure		first active first inactive

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 65
Sinus rhythm, PR < 220ms, QRS < 110ms
Heart failure (NYHA class III-IV or II with hospitalization for heart failure)
Ejection Fraction > 50%, restrictive mitral inflow, Lateral E/e' > 12 or septal E/e' > 15, Left atrial index volume > 34 ml/m²
Atrial dyssynchrony syndrome: (TTE) inter-atrial time delay ≥ 70ms (difference between tricuspid and mitral P-A intervals or between mitral and tricupsid P-A' intervals with DTI)
Left atrio-ventricular asynchrony: Time Difference between tricupsid and mitral A wave duration ≥ 35ms.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided