CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 506 enrolled
Drug / intervention
MultiPoint Pacing +1 moredevice
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/NCT01786993
NCT01786993Phase 3Completed
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MultiPoint Pacing IDE Study

Abbott Medical Devices·interventional·Posted Feb 8, 2013·Updated Feb 4, 2019

In Brief

A Phase 3 clinical trial evaluating MultiPoint Pacing and Traditional Biventricular Pacing for Heart Failure. Completed, enrolled 506 participants across 49 sites.

Detailed Summary

This IDE study is a prospective, randomized, double-blind, multi-center clinical study to evaluate the safety and efficacy of patient treatment with MPP compared to patient treatment with standard BiV pacing at 9 months. The study will be conducted at a maximum of 50 investigational centers located in the United States. A maximum of 506 subjects implanted with the Quadripolar cardiac resynchronization therapy device (CRT-D) system will be enrolled in the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2013
Enrollment StartApr 1, 2013
Primary CompletionApr 1, 2015
Study CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 13.4 years ago

Interventions

MultiPoint Pacingdevice

Subjects are programmed to MPP between 3 and 9 months. MPP programming is stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.

Traditional Biventricular Pacingdevice

Subjects are programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.