Back to resultsLEft Atrial Pacing in Diastolic Heart Failure (LEAD)
Primary Purpose
Heart Failure With Preserved Ejection Fraction, Atrial Dyssynchrony Syndrome, Left Atrio-ventricular Asynchrony
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
pace make active/inactive cross over
Sponsored by
About this trial
This is an interventional trial for Heart Failure With Preserved Ejection Fraction focused on measuring Heart failure with preserved ejection fraction, atrial dyssynchrony syndrome, left atrio-ventricular asynchrony, pacemaker, left atrial pacing therapy
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.
Sites / Locations
- CHU Dijon
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
first active
first inactive
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01618981
First Posted
June 7, 2012
Last Updated
December 26, 2018
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT01618981
Brief Title
LEft Atrial Pacing in Diastolic Heart Failure
Acronym
LEAD
Official Title
LEft Atrial Pacing in Diastolic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
first active
Arm Type
Experimental
Arm Title
first inactive
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
pace make active/inactive cross over
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
12. IPD Sharing Statement
Learn more about this trial
LEft Atrial Pacing in Diastolic Heart Failure
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