ALternate Site Cardiac ReSYNChronization (ALSYNC) Study (ALSYNC)
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ClinicalTrials.gov Identifier: NCT01277783 |
Recruitment Status
: Unknown
Verified June 2013 by Medtronic Cardiac Rhythm and Heart Failure.
Recruitment status was: Enrolling by invitation
First Posted
: January 17, 2011
Last Update Posted
: June 19, 2013
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Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure
Tracking Information | ||||
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First Submitted Date ICMJE | January 11, 2011 | |||
First Posted Date ICMJE | January 17, 2011 | |||
Last Update Posted Date | June 19, 2013 | |||
Study Start Date ICMJE | January 2011 | |||
Estimated Primary Completion Date | April 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Percentage of patients free from lead, delivery system and implant related complications. [ Time Frame: Six months ] | |||
Original Primary Outcome Measures ICMJE |
Percentage of patients free from lead, delivery system and implant related complications [ Time Frame: Six months ] | |||
Change History | Complete list of historical versions of study NCT01277783 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | ALternate Site Cardiac ReSYNChronization (ALSYNC) Study | |||
Official Title ICMJE | ALternate Site Cardiac ReSYNChronization Study | |||
Brief Summary | The ALternate site cardiac reSYNChronization (ALSYNC) study, a non-comparative, prospective, non-randomized, multi-national clinical investigation. The purpose of this clinical investigation is to evaluate the safety and performance of the investigational atrial transseptal endocardial LV lead delivery system and the implant procedure for delivering the SelectSecure® Model 3830 lead into the Left Ventricle via a superior approach, and to evaluate the performance of the SelectSecure® Model 3830 lead in the Left Ventricle. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Heart Failure | |||
Intervention ICMJE |
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Study Arms | Not Provided | |||
Publications * |
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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 | Unknown status | |||
Estimated Enrollment ICMJE |
130 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date | December 2014 | |||
Estimated Primary Completion Date | April 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Canada, France, Hungary, Italy, Netherlands, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01277783 | |||
Other Study ID Numbers ICMJE | ALSYNC | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Medtronic Cardiac Rhythm and Heart Failure | |||
Study Sponsor ICMJE | Medtronic Cardiac Rhythm and Heart Failure | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Medtronic Cardiac Rhythm and Heart Failure | |||
Verification Date | June 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |