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LEft Atrial Pacing in Diastolic Heart Failure (LEAD)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01618981
First Posted: June 14, 2012
Last Update Posted: January 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
  Purpose
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 Intervention
Heart Failure With Preserved Ejection Fraction Atrial Dyssynchrony Syndrome Left Atrio-ventricular Asynchrony Procedure: pace make active/inactive cross over

Study Type: Interventional
Official Title: LEft Atrial Pacing in Diastolic Heart Failure

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

Study Start Date: September 2012
Arms Assigned Interventions
Experimental: first active Procedure: pace make active/inactive cross over
Experimental: first inactive Procedure: pace make active/inactive cross over

  Eligibility

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
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.
  Contacts and Locations
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


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

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

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01618981     History of Changes
Other Study ID Numbers: LAURENT PHRC N 2011
First Submitted: June 7, 2012
First Posted: June 14, 2012
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
pacemaker
left atrial pacing therapy

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