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NCT01066078 Clinical Trial

Echocardiography and Peak Endocardial Acceleration (PEA) Measurements in Cardiac Resynchronization Therapy (CRT)

Congestive Heart Failure Clinical Trial

Official title:
Echocardiography and PEA Measurements in CRT Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01066078
Other study ID # RGEA01 - CAP PEA
Secondary ID RGEA01
Status Completed
Phase N/A
First received February 9, 2010
Last updated March 4, 2010
Start date October 2007
Est. completion date October 2009

Study information
Verified date March 2010
Source LivaNova
Contact n/a
Is FDA regulated No
Health authority France: French Data Protection Authority
Study type Observational

Clinical Trial Summary

This study used an external endocardial acceleration sensor (sonR sensor), placed on the patient's chest, to time the closure of aortic and mitral valves, and compared its performance with echocardiography.

Recruitment information / eligibility
Status Completed
Enrollment 216
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Every patient coming in the participating centers for an echocardiographic exam and implanted with a pacemaker or an implantable cardioverter defibrillator (ICD) can be included in the study.

Exclusion Criteria:

- Inability to understand the patient information sheet.

- Minor patient or pregnant woman.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Echocardiography and SonR recording

Locations
Country Name City State
France Nouvelles Cliniques Nantaises Nantes
France Clinique Bizet Paris
France CHU Pontchaillou Rennes
France CHU Rennes Rennes

Sponsors (1)
Lead Sponsor Collaborator
LivaNova

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary The timings of mitral (tMC) and aortic (tAC) valves closure by echocardiography and sonR 12 months No
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