Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461734
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2007-04-17
Brief Title:
PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROTECT-PACE
Brief 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
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
Detailed Description:
There is an increasing amount of evidence to suggest that other positions in the heart may be more effective than the conventional Right Ventricular Apex RVA position for restoring good heart function The best site to place a lead has not yet been proven
This is a study comparing the long term clinical effects of two different lead positions The measurements taken to assess the clinical effects include
the effectiveness of the hearts pumping action as measured by ultrasound scans
measurements of how far patients can walk in 6 minutes
analysis of blood samples
collection of information from the pacemaker about heart rhythm problems
Half of the patients in the study will receive conventional leads placed in the more common RVA position in the heart The other half will receive a relatively new type of lead placed in what is called the Right Ventricular High Septal RVHS position
In order to fairly compare the outcomes of these two different lead positions this study has been designed as a randomized blind trial This means that the group which patients will be entered into will be chosen at random and patients will not be told which group they are in
Patients will each have an equal 5050 chance of being in either group By carefully comparing the clinical differences between the two groups of patients the study aims to prove whether or not there are additional benefits for patients when the RVHS lead position is used
All leads used in the study have been shown to be safe for patients and are available commercially for implantation All of the implanting doctors involved in the study are experienced at implanting the pacemakers and leads that will be used in this study
This is a study comparing the long term clinical effects of two different lead positions The measurements taken to assess the clinical effects include
the effectiveness of the hearts pumping action as measured by ultrasound scans
measurements of how far patients can walk in 6 minutes
analysis of blood samples
collection of information from the pacemaker about heart rhythm problems
Half of the patients in the study will receive conventional leads placed in the more common RVA position in the heart The other half will receive a relatively new type of lead placed in what is called the Right Ventricular High Septal RVHS position
In order to fairly compare the outcomes of these two different lead positions this study has been designed as a randomized blind trial This means that the group which patients will be entered into will be chosen at random and patients will not be told which group they are in
Patients will each have an equal 5050 chance of being in either group By carefully comparing the clinical differences between the two groups of patients the study aims to prove whether or not there are additional benefits for patients when the RVHS lead position is used
All leads used in the study have been shown to be safe for patients and are available commercially for implantation All of the implanting doctors involved in the study are experienced at implanting the pacemakers and leads that will be used in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None