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LEft Atrial Pacing in Diastolic Heart Failure (LEAD)

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ClinicalTrials.gov Identifier: NCT01618981
Recruitment Status : Unknown
Verified January 2014 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : June 14, 2012
Last Update Posted : January 7, 2014
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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.

Condition or disease Intervention/treatment
Heart Failure With Preserved Ejection Fraction Atrial Dyssynchrony Syndrome Left Atrio-ventricular Asynchrony Procedure: pace make active/inactive cross over

Study Type : Interventional  (Clinical Trial)
Official Title: LEft Atrial Pacing in Diastolic Heart Failure
Study Start Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Experimental: first active Procedure: pace make active/inactive cross over
Experimental: first inactive Procedure: pace make active/inactive cross over

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01618981

Contact: Gabriel LAURENT 01133 380293536 gabriel.laurent@chu-dijon.fr
Contact: Jean Christophe EICHER 01133 380293313 jean-christophe.eicher@chu-dijon.fr

CHU Dijon Recruiting
Dijon, France, 21079
Principal Investigator: Gabriel LAURENT         
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01618981     History of Changes
Other Study ID Numbers: LAURENT PHRC N 2011
First Posted: June 14, 2012    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014

Keywords provided by Centre Hospitalier Universitaire Dijon:
Heart failure with preserved ejection fraction
atrial dyssynchrony syndrome
left atrio-ventricular asynchrony
left atrial pacing therapy

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases