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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
Date last updated
25/04/2017

Titles & IDs
Public title
PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing
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?
Secondary ID [1] 0 0
PROTECT-PACE Version 4
Universal Trial Number (UTN)
Trial acronym
PROTECT-PACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Left Ventricular Dysfunction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort).
Timepoint [1] 0 0
At 2-year follow-up
Primary outcome [2] 0 0
Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Per Protocol Cohort).
Timepoint [2] 0 0
At 2-year follow-up
Secondary outcome [1] 0 0
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)
Timepoint [1] 0 0
At 2-year follow-up
Secondary outcome [2] 0 0
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)
Timepoint [2] 0 0
At 2-year follow-up
Secondary outcome [3] 0 0
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)
Timepoint [3] 0 0
At 5-years follow-up (study extension)
Secondary outcome [4] 0 0
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)
Timepoint [4] 0 0
At 5-year follow-up (study extension)
Secondary outcome [5] 0 0
Worsening of Heart Failure
Timepoint [5] 0 0
At 5-year follow-up (study extension)
Secondary outcome [6] 0 0
All Cause Mortality
Timepoint [6] 0 0
At 5-year follow-up (study extension)
Secondary outcome [7] 0 0
Incidence of Stroke
Timepoint [7] 0 0
At 5-year follow-up (study extension)
Secondary outcome [8] 0 0
Brain Natriuretic Peptide Levels (Intent to Treat Cohort)
Timepoint [8] 0 0
At 2-year follow-up
Secondary outcome [9] 0 0
Brain Natriuretic Peptide Levels (Per Protocol Cohort)
Timepoint [9] 0 0
At 2-year follow-up
Secondary outcome [10] 0 0
Echocardiographic Measures of Left Ventricular Dyssynchrony
Timepoint [10] 0 0
At 2-year follow-up
Secondary outcome [11] 0 0
6 Minute Hall-Walk Distance (Intent to Treat Cohort)
Timepoint [11] 0 0
At 2-year follow-up
Secondary outcome [12] 0 0
6 Minute Hall-Walk Distance (Per Protocol Cohort)
Timepoint [12] 0 0
At 2-year follow-up

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
248
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [2] 0 0
Royal Brisbane & Womens' Hospital - Brisbane
Recruitment hospital [3] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [4] 0 0
Calvary Wakefield Hospital - Adelaide
Recruitment hospital [5] 0 0
Flinders Medical Center - Adelaide
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Blackpool
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Bournemouth
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Cardiff
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Colchester
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Leeds
Country [8] 0 0
United Kingdom
State/province [8] 0 0
London
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Middlesbrough
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Norwich
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Orpington, Kent
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00461734
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.
Public notes

Contacts
Principal investigator
Name 0 0
Dr. Gerald Kaye
Address 0 0
Princess Alexandra Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00461734