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LEft Atrial Pacing in Diastolic Heart Failure (LEAD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Centre Hospitalier Universitaire Dijon
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01618981
First received: June 7, 2012
Last updated: January 6, 2014
Last verified: January 2014
  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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01618981     History of Changes
Other Study ID Numbers: LAURENT PHRC N 2011
Study First Received: June 7, 2012
Last Updated: January 6, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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
Syndrome
Cardiovascular Diseases
Disease
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014