LEft Atrial Pacing in Diastolic Heart Failure

Heart Failure With Preserved Ejection Fraction Clinical Trial

— LEAD  

Official title:

LEft Atrial Pacing in Diastolic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01618981
• Other study ID #: LAURENT PHRC N 2011
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: April 2016

Study information

• Verified date: December 2018
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• pace make active/inactive cross over

Locations

Country	Name	City	State
France	CHU Dijon	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France,