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LEft Atrial Pacing in Diastolic Heart Failure

NCT ID: NCT01618981

Last Updated: 2018-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-04-30

Brief Summary

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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

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Conditions

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

Keywords

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

Study Groups

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first active

Group Type EXPERIMENTAL

pace make active/inactive cross over

Intervention Type PROCEDURE

first inactive

Group Type EXPERIMENTAL

pace make active/inactive cross over

Intervention Type PROCEDURE

Interventions

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pace make active/inactive cross over

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Dijon

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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LAURENT PHRC N 2011

Identifier Type: -

Identifier Source: org_study_id