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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RV Apex | Active Comparator |
| |
| RV High Septum | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RV lead placement site | Other | Patients randomised to RV apical or high septal lead placement site |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort). | At 2-year follow-up | |
| Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Per Protocol Cohort). | At 2-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort) | At 2-year follow-up | |
| Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort) | At 2-year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Gerald Kaye | Princess Alexandra Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Alexandra Hospital | Brisbane | Queensland | Australia | |||
| Royal Brisbane & Womens' Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26517949 | Derived | 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. | |
| 25862716 |
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Partecipants initially assessed for eligibility were 248 of whom 8 were excluded before the randomization due to the following causes:
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| ID | Title | Description |
|---|---|---|
| FG000 | RV Apex | RV lead placement site: Patients randomised to RV apical lead placement site |
| FG001 | RV High Septum | RV lead placement site: Patients randomised to RV high septal lead placement site |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort) | At 5-years follow-up (study extension) |
| Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort) | At 5-year follow-up (study extension) |
| Worsening of Heart Failure | Worsening of heart failure can be defined as:
| At 5-year follow-up (study extension) |
| All Cause Mortality | At 5-year follow-up (study extension) |
| Incidence of Stroke | At 5-year follow-up (study extension) |
| Brain Natriuretic Peptide Levels (Intent to Treat Cohort) | At 2-year follow-up |
| Brain Natriuretic Peptide Levels (Per Protocol Cohort) | At 2-year follow-up |
| Echocardiographic Measures of Left Ventricular Dyssynchrony | No analysis has been done for this section since that variable was not collected during the study. | At 2-year follow-up |
| 6 Minute Hall-Walk Distance (Intent to Treat Cohort) | At 2-year follow-up |
| 6 Minute Hall-Walk Distance (Per Protocol Cohort) | At 2-year follow-up |
| Brisbane |
| Queensland |
| Australia |
| The Prince Charles Hospital | Brisbane | Queensland | Australia |
| Calvary Wakefield Hospital | Adelaide | South Australia | Australia |
| Flinders Medical Center | Adelaide | South Australia | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | Australia |
| Auckland City Hospital | Auckland | New Zealand |
| Christchurch Hospital | Christchurch | New Zealand |
| Blackpool Victoria Hospital | Blackpool | United Kingdom |
| Royal Bournemouth Hospital | Bournemouth | United Kingdom |
| University Hospital of Wales | Cardiff | United Kingdom |
| Colchester General | Colchester | United Kingdom |
| Leeds General Infirmary | Leeds | United Kingdom |
| St. Thomas' Hospital | London | United Kingdom |
| James Cook University Hospital | Middlesbrough | United Kingdom |
| Norfolk and Norwich University Hospital | Norwich | United Kingdom |
| Princess Royal Hospital | Orpington, Kent | United Kingdom |
| New Cross Hospital | Wolverhampton | United Kingdom |
| Derived |
| 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. |
| 25666325 | Derived | 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. |
| 25189602 | Derived | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | RV Apex | RV lead placement site: Patients randomised to RV apical lead placement site |
| BG001 | RV High Septum | RV lead placement site: Patients randomised to RV high septal lead placement site |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort). | Intent to Treat Cohort with data available | Posted | Mean | Standard Deviation | percentage | At 2-year follow-up |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Per Protocol Cohort). | Per Protocol Cohort with data available | Posted | Mean | Standard Deviation | percentage | At 2-year follow-up |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort) | Intent to Treat Cohort with data available | Posted | Mean | Standard Deviation | minutes per day | At 2-year follow-up |
|
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| Secondary | Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort) | Per Protocol Cohort with data available | Posted | Mean | Standard Deviation | minutes per day | At 2-year follow-up |
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| Secondary | Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort) | Intent to Treat Cohort with data available | Posted | Mean | Standard Deviation | minutes per day | At 5-years follow-up (study extension) |
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| Secondary | Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort) | Per Protocol Cohort with data available | Posted | Mean | Standard Deviation | minutes per day | At 5-year follow-up (study extension) |
|
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| Secondary | Worsening of Heart Failure | Worsening of heart failure can be defined as:
| Posted | Number | episodes | At 5-year follow-up (study extension) |
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| Secondary | All Cause Mortality | Posted | Number | participants | At 5-year follow-up (study extension) |
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| Secondary | Incidence of Stroke | Posted | Number | participants | At 5-year follow-up (study extension) |
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| Secondary | Brain Natriuretic Peptide Levels (Intent to Treat Cohort) | Intent to Treat Cohort with data available | Posted | Median | Full Range | picograms per milliliter | At 2-year follow-up |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Brain Natriuretic Peptide Levels (Per Protocol Cohort) | Per Protocol Cohort with data available | Posted | Median | Full Range | picograms per milliliter | At 2-year follow-up |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Echocardiographic Measures of Left Ventricular Dyssynchrony | No analysis has been done for this section since that variable was not collected during the study. | No analysis has been done for this section since that variable was not collected during the study | Posted | At 2-year follow-up |
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| Secondary | 6 Minute Hall-Walk Distance (Intent to Treat Cohort) | Intent to Treat Cohort with data available | Posted | Median | Inter-Quartile Range | meters | At 2-year follow-up |
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| Secondary | 6 Minute Hall-Walk Distance (Per Protocol Cohort) | Per Protocol Cohort with data available | Posted | Median | Inter-Quartile Range | meters | At 2-year follow-up |
|
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RV Apex | RV lead placement site: Patients randomised to RV apical lead placement site | 78 | 120 | 6 | 120 | ||
| EG001 | RV High Septum | RV lead placement site: Patients randomised to RV high septal lead placement site | 81 | 120 | 0 | 120 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
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| SOB | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| diabets | Endocrine disorders | MedDRA 19.0 | Non-systematic Assessment |
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| rectal bleeding | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
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| chest pain | General disorders | MedDRA 19.0 | Non-systematic Assessment |
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| bile duct | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
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| infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
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| trauma | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
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| angiography | Investigations | MedDRA 19.0 | Non-systematic Assessment |
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| dehydration | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
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| arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
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| carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
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| stroke | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
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| urinary tract infection | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
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| prostate | Reproductive system and breast disorders | MedDRA 19.0 | Non-systematic Assessment |
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| pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
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| dermatitis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
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| bypass | Surgical and medical procedures | MedDRA 19.0 | Non-systematic Assessment |
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| raynaud's disease | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
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| death | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| product issue | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment | Adverse events related to the pacemaker (e.g., lead dislodgment or changing in threshold values). The term 'product issue' is taken from MedDRA 19.0 classification. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gerald Kaye | Princess Alexandra Hospital | 07 3176 2111 | gerald.kaye@health.qld.gov.au |
| ID | Term |
|---|---|
| D018487 | Ventricular Dysfunction, Left |
| D006327 | Heart Block |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Male |
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| United Kingdom |
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| Australia |
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