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Tracking Information | |||||
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First Received Date † | April 17, 2007 | ||||
Last Updated Date | April 23, 2009 | ||||
Start Date † | May 2007 | ||||
Current Primary Outcome Measures † |
Comparison of change in Left Ventricular Ejection Fraction between the two patient groups. [ Time Frame: At 2-year follow-up ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00461734 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing | ||||
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? | ||||
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. |
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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:
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 (50:50) 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. |
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Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study | ||||
Condition † | Left Ventricular Dysfunction | ||||
Intervention † | Other: RV lead placement site | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 238 | ||||
Estimated Completion Date | April 2012 | ||||
Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | Australia, New Zealand, United Kingdom | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00461734 | ||||
Responsible Party | Medtronic UK Ltd, Medtronic UK Ltd | ||||
Secondary IDs †† | |||||
Study Sponsor † | Medtronic Cardiac Rhythm Disease Management | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Medtronic Cardiac Rhythm Disease Management | ||||
Verification Date | April 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |