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

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. Identifier: NCT01066078
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : March 5, 2010
Information provided by:

Brief 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.

Condition or disease Intervention/treatment
Congestive Heart Failure Other: Echocardiography and SonR recording

Study Type : Observational
Actual Enrollment : 216 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Echocardiography and PEA Measurements in CRT Therapy
Study Start Date : October 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Group/Cohort Intervention/treatment
CRT recipients Other: Echocardiography and SonR recording

Primary Outcome Measures :
  1. The timings of mitral (tMC) and aortic (tAC) valves closure by echocardiography and sonR [ Time Frame: 12 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
CRT recipients

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.

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 identifier (NCT number): NCT01066078

Nouvelles Cliniques Nantaises
Nantes, France
Clinique Bizet
Paris, France, 75016
CHU Pontchaillou
Rennes, France
CHU Rennes
Rennes, France
Sponsors and Collaborators
Principal Investigator: Erwan DONAL, MD CHU Rennes

Responsible Party: Erwan DONAL, CCP, CHU Pontchaillou 35033 RENNES France Identifier: NCT01066078     History of Changes
Other Study ID Numbers: RGEA01 - CAP PEA
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: March 5, 2010
Last Verified: March 2010

Keywords provided by LivaNova:
heart failure - congestive
Cardiovascular imaging agents/Techniques]
Other diagnostic testing
Other Treatment
Recipients of cardiac resynchronization therapy systems

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases