CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 248 enrolled
Drug / intervention
RV lead placement siteother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00461734
NCT00461734N/ACompleted

PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing. Does Right Ventricular High-septal Pacing Improve Outcome Compared With Right Ventricular Apical Pacing?

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Apr 18, 2007·Updated Apr 25, 2017

In Brief

A clinical study evaluating RV lead placement site for Left Ventricular Dysfunction. Completed, enrolled 248 participants across 18 sites in 3 countries.

Detailed Summary

This study will be done in patients who require the implantation of a cardiac pacemaker (an electronic device that controls the heartbeat) for complete heart block (a heart rhythm abnormality resulting in a slow heart beat). Pacemakers regulate the heart beat by delivering pulses of electricity through special wires (pacing leads) which are placed inside the heart. This study will compare two groups of pacemaker patients. Each group will have their pacing leads placed in a particular location in the heart. The purpose of the study is to show whether the position used in one group is better for maintaining effective heart function compared to the position used in the other group. The leads in one group will be placed in a position called the Right Ventricular Apex. This is the traditional and most frequently used position for pacemaker leads. The leads in the other group will be placed in a position called the Right Ventricular High Septum. This is a less commonly used position, but may result in health benefits for the patients compared with the Right Ventricular Apex.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, New Zealand, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 18, 2007
Enrollment StartAug 1, 2007
Primary CompletionOct 1, 2013
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 19.2 years ago

Interventions

RV lead placement siteother

Patients randomised to RV apical or high septal lead placement site