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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00461734
Registration number
NCT00461734
Ethics application status
Date submitted
17/04/2007
Date registered
18/04/2007
Titles & IDs
Public title
PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing
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Scientific 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?
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Secondary ID [1]
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PROTECT-PACE Version 4
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Universal Trial Number (UTN)
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Trial acronym
PROTECT-PACE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Left Ventricular Dysfunction
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - RV lead placement site
Active comparator: RV Apex -
Experimental: RV High Septum -
Other interventions: RV lead placement site
Patients randomised to RV apical or high septal lead placement site
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort).
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Assessment method [1]
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Timepoint [1]
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At 2-year follow-up
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Primary outcome [2]
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Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Per Protocol Cohort).
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Assessment method [2]
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Timepoint [2]
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At 2-year follow-up
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Secondary outcome [1]
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Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)
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Assessment method [1]
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Timepoint [1]
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At 2-year follow-up
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Secondary outcome [2]
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Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)
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Assessment method [2]
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Timepoint [2]
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At 2-year follow-up
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Secondary outcome [3]
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Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)
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Assessment method [3]
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Timepoint [3]
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At 5-years follow-up (study extension)
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Secondary outcome [4]
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Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)
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Assessment method [4]
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Timepoint [4]
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At 5-year follow-up (study extension)
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Secondary outcome [5]
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Worsening of Heart Failure
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Assessment method [5]
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Worsening of heart failure can be defined as:
1. Heart failure-related hospitalization requiring intravenous heart failure therapy, or
2. Emergency department visit for heart failure requiring intravenous heart failure therapy, or
3. Any other visit in which the patient presents with signs or symptoms consistent with heart failure or heart failure exacerbation or marked decline in ejection fraction \<35%, and intravenous heart failure therapy is required or titrate therapy.
4. CRT-P or CRT-D upgrade.
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Timepoint [5]
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At 5-year follow-up (study extension)
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Secondary outcome [6]
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All Cause Mortality
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Assessment method [6]
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Timepoint [6]
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At 5-year follow-up (study extension)
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Secondary outcome [7]
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Incidence of Stroke
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Assessment method [7]
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Timepoint [7]
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At 5-year follow-up (study extension)
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Secondary outcome [8]
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Brain Natriuretic Peptide Levels (Intent to Treat Cohort)
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Assessment method [8]
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0
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Timepoint [8]
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At 2-year follow-up
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Secondary outcome [9]
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Brain Natriuretic Peptide Levels (Per Protocol Cohort)
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Assessment method [9]
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Timepoint [9]
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At 2-year follow-up
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Secondary outcome [10]
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Echocardiographic Measures of Left Ventricular Dyssynchrony
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Assessment method [10]
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No analysis has been done for this section since that variable was not collected during the study.
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Timepoint [10]
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At 2-year follow-up
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Secondary outcome [11]
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6 Minute Hall-Walk Distance (Intent to Treat Cohort)
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Assessment method [11]
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Timepoint [11]
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At 2-year follow-up
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Secondary outcome [12]
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6 Minute Hall-Walk Distance (Per Protocol Cohort)
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Assessment method [12]
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Timepoint [12]
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At 2-year follow-up
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Eligibility
Key inclusion criteria
* Patients with high grade AV block and sinus rhythm, scheduled to undergo dual chamber pacemaker implantation OR patients with high grade AV block and permanent atrial fibrillation, scheduled to undergo single chamber ventricular pacemaker implantation.
* Patients aged 18 years or older.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patients indicated for an Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy.
* Patients following junctional ablation.
* Patients with a Myocardial Infarction within three months prior to enrollment.
* Patients that received bypass surgery within three months prior to enrollment.
* Patients that had a valve replacement within three months prior to enrollment or patients with a mechanical right heart valve.
* Patients where a right ventricular lead cannot be placed i.e. complex congenital heart disease.
* Patients with hypertrophic obstructive cardiomyopathy.
* Patients with acute coronary syndrome, unstable angina, severe mitral regurgitation and/or hemodynamically significant aortic stenosis.
* Previous implanted pacemaker or cardioverter defibrillator.
* Known paroxysmal atrial fibrillation or a documented episode of atrial fibrillation prior to enrollment.
* Patients on amiodarone therapy within the last six months prior to enrollment.
* Terminal conditions with a life expectancy of less than two years.
* Participation in any other study that would confound the results of this study.
* Psychological or emotional problems that may interfere with the volunteer's ability to provide full consent or fully understand the purposes of the study.
* Pregnant patients or patients who may become pregnant during the time-scale of the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2015
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Sample size
Target
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Accrual to date
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Final
248
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Recruitment in Australia
Recruitment state(s)
QLD,SA
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Recruitment hospital [1]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [2]
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Royal Brisbane & Womens' Hospital - Brisbane
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Recruitment hospital [3]
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The Prince Charles Hospital - Brisbane
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Recruitment hospital [4]
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Calvary Wakefield Hospital - Adelaide
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Recruitment hospital [5]
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Flinders Medical Center - Adelaide
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Recruitment hospital [6]
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Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
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- Brisbane
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Recruitment postcode(s) [2]
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- Adelaide
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Christchurch
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Country [3]
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United Kingdom
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State/province [3]
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Blackpool
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Country [4]
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United Kingdom
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State/province [4]
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Bournemouth
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Country [5]
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United Kingdom
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State/province [5]
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Cardiff
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Country [6]
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United Kingdom
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State/province [6]
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Colchester
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Country [7]
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United Kingdom
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State/province [7]
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Leeds
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Country [8]
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United Kingdom
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State/province [8]
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London
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Country [9]
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United Kingdom
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State/province [9]
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Middlesbrough
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Country [10]
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United Kingdom
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State/province [10]
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Norwich
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Country [11]
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United Kingdom
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State/province [11]
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Orpington, Kent
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Country [12]
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United Kingdom
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State/province [12]
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Medtronic Cardiac Rhythm and Heart Failure
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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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Trial website
https://clinicaltrials.gov/study/NCT00461734
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Trial related presentations / publications
Saito M, Iannaccone A, Kaye G, Negishi K, Kosmala W, Marwick TH; PROTECT-PACE investigators. Effect of Right Ventricular Pacing on Right Ventricular Mechanics and Tricuspid Regurgitation in Patients With High-Grade Atrioventricular Block and Sinus Rhythm (from the Protection of Left Ventricular Function During Right Ventricular Pacing Study). Am J Cardiol. 2015 Dec 15;116(12):1875-82. doi: 10.1016/j.amjcard.2015.09.041. Epub 2015 Oct 9. Kosmala W, Saito M, Kaye G, Negishi K, Linker N, Gammage M, Marwick TH; Protect-Pace Investigators. Incremental value of left atrial structural and functional characteristics for prediction of atrial fibrillation in patients receiving cardiac pacing. Circ Cardiovasc Imaging. 2015 Apr;8(4):e002942. doi: 10.1161/CIRCIMAGING.114.002942. Saito M, Kaye G, Negishi K, Linker N, Gammage M, Kosmala W, Marwick TH; Protect-Pace investigators. Dyssynchrony, contraction efficiency and regional function with apical and non-apical RV pacing. Heart. 2015 Apr;101(8):600-8. doi: 10.1136/heartjnl-2014-306990. Epub 2015 Feb 9. Kaye GC, Linker NJ, Marwick TH, Pollock L, Graham L, Pouliot E, Poloniecki J, Gammage M; Protect-Pace trial investigators. Effect of right ventricular pacing lead site on left ventricular function in patients with high-grade atrioventricular block: results of the Protect-Pace study. Eur Heart J. 2015 Apr 7;36(14):856-62. doi: 10.1093/eurheartj/ehu304. Epub 2014 Sep 4.
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Public notes
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Contacts
Principal investigator
Name
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Dr. Gerald Kaye
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Address
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Princess Alexandra Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00461734