CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 138 enrolled
Drug / intervention
Endocardial Left Ventricular pacingdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01277783
NCT01277783N/ACompleted
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ALternate Site Cardiac ReSYNChronization Study

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Jan 17, 2011·Updated Jun 20, 2019

In Brief

A clinical study evaluating Endocardial Left Ventricular pacing for Heart Failure. Completed, enrolled 138 participants across 18 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesBelgium, Canada, France, Hungary, Italy, Netherlands, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 17, 2011
Enrollment StartMar 1, 2011
Primary CompletionApr 1, 2014
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.5 years ago

Interventions

Endocardial Left Ventricular pacingdevice

Subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter, using trans esophageal echo (TEE) or intra-cardiac echo (ICE) to guide the procedure.