Echocardiography and Peak Endocardial Acceleration (PEA) Measurements in Cardiac Resynchronization Therapy (CRT)
This study has been completed.
Sponsor:
Sorin Group
Information provided by:
Sorin Group
ClinicalTrials.gov Identifier:
NCT01066078
First received: February 9, 2010
Last updated: March 4, 2010
Last verified: March 2010
| Tracking Information | |||||
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| First Received Date ICMJE | February 9, 2010 | ||||
| Last Updated Date | March 4, 2010 | ||||
| Start Date ICMJE | October 2007 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The timings of mitral (tMC) and aortic (tAC) valves closure by echocardiography and sonR [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
The timings of mitral (tMC) and aortic (tAC) valves closure by echocardiography and sonR [ Time Frame: Routine follow up ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01066078 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Echocardiography and Peak Endocardial Acceleration (PEA) Measurements in Cardiac Resynchronization Therapy (CRT) | ||||
| Official Title ICMJE | Echocardiography and PEA Measurements in CRT Therapy | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | CRT recipients |
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| Condition ICMJE | Congestive Heart Failure | ||||
| Intervention ICMJE | Other: Echocardiography and SonR recording | ||||
| Study Group/Cohort (s) | CRT recipients
Intervention: Other: Echocardiography and SonR recording |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 216 | ||||
| Completion Date | October 2009 | ||||
| Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01066078 | ||||
| Other Study ID Numbers ICMJE | RGEA01 - CAP PEA, RGEA01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Erwan DONAL, CCP, CHU Pontchaillou 35033 RENNES France | ||||
| Study Sponsor ICMJE | Sorin Group | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Sorin Group | ||||
| Verification Date | March 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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