LEft Atrial Pacing in Diastolic Heart Failure (LEAD)
This study is not yet open for participant recruitment.
Verified January 2013 by Centre Hospitalier Universitaire Dijon
Sponsor:
Centre Hospitalier Universitaire Dijon
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01618981
First received: June 7, 2012
Last updated: January 4, 2013
Last verified: January 2013
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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
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 | Not yet 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 4, 2013 |
| Health Authority: | France: L’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 Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013