At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 122 enrolled
Drug / intervention
Optimized interventricular delay biventricular 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.
Clinical Investigation to Study Safety and Efficacy of the Interventricular Delay Feature of the Lumax HF-T Device for Heart Failure.
In Brief
A Phase 2 clinical trial evaluating Optimized interventricular delay biventricular pacing for Congestive Heart Failure. Completed, enrolled 122 participants across 19 sites in 2 countries.
Detailed Summary
The purpose of this study is to demonstrate that the safety and efficacy of the Lumax HF-T with optimized interventricular delay biventricular pacing (OPT) is non-inferior to the Lumax HF-T with simultaneous biventricular pacing (SIM) in patients with heart failure requiring cardiac resynchronization therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongestive Heart Failure
CountriesSwitzerland, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2007
First PostedJul 2007
Primary CompletionDec 2008
Study CompletionAug 2009
TodayJul 2026
First PostedJul 30, 2007
Enrollment StartJul 1, 2007
Primary CompletionDec 1, 2008
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.9 years ago
Interventions
Optimized interventricular delay biventricular pacingdevice
Lumax HF-T with optimized interventricular delay biventricular pacing