Left Ventricular DysfunctionPROTECT-PACENCT00461734
PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing
A study testing RV lead placement site in people with Left Ventricular Dysfunction, run by Medtronic Cardiac Rhythm and Heart Failure at 18 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Dysfunction
- What is being tested?
- RV lead placement site
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 18 sitesin 3 countries
- Study dates
- Aug 2007to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United Kingdom10 sites
Blackpool Victoria Hospital
Blackpool
Royal Bournemouth Hospital
Bournemouth
University Hospital of Wales
Cardiff
Colchester General
Colchester
Leeds General Infirmary
Leeds
St. Thomas' Hospital
London
James Cook University Hospital
Middlesbrough
Norfolk and Norwich University Hospital
Norwich
Princess Royal Hospital
Orpington, Kent
New Cross Hospital
Wolverhampton
Australia6 sites
Calvary Wakefield Hospital
Adelaide, South Australia
Flinders Medical Center
Adelaide, South Australia
Royal Adelaide Hospital
Adelaide, South Australia
Princess Alexandra Hospital
Brisbane, Queensland
Royal Brisbane & Womens' Hospital
Brisbane, Queensland
The Prince Charles Hospital
Brisbane, Queensland
New Zealand2 sites
Auckland City Hospital
Auckland
Christchurch Hospital
Christchurch
About this study
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?
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.
Read more
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.
Read the 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 heart's 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 (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.
- Conditions
- Left Ventricular Dysfunction
- Being tested
- RV lead placement site
- Keywords
- Right Ventricular High Septal Pacing, Right Ventricular Apical Pacing, Left Ventricular Dysfunction, Heart Block, Pacemaker, Atrial Fibrillation, Ejection Fraction
- Medical subject headings
- Ventricular Dysfunction, Left, Heart Block, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV lead placement siteOther
Patients randomised to RV apical or high septal lead placement site
| Study group | Role | What they receive |
|---|---|---|
| RV Apex | Active comparator | Not described Receives: Other: RV lead placement site |
| RV High Septum | Experimental | Not described Receives: Other: RV lead placement site |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort).
Measured: At 2-year follow-up
Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Per Protocol Cohort).
Measured: At 2-year follow-up
Secondary outcomes (12)
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)
Measured: At 2-year follow-up
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)
Measured: At 2-year follow-up
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)
Measured: At 5-years follow-up (study extension)
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)
Measured: At 5-year follow-up (study extension)
Worsening of Heart Failure
Worsening of heart failure can be defined as:
- Heart failure-related hospitalization requiring intravenous heart failure therapy, or
- Emergency department visit for heart failure requiring intravenous heart failure therapy, or
- 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.
- CRT-P or CRT-D upgrade.
Measured: At 5-year follow-up (study extension)
All Cause Mortality
Measured: At 5-year follow-up (study extension)
Incidence of Stroke
Measured: At 5-year follow-up (study extension)
Brain Natriuretic Peptide Levels (Intent to Treat Cohort)
Measured: At 2-year follow-up
Brain Natriuretic Peptide Levels (Per Protocol Cohort)
Measured: 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.
Measured: At 2-year follow-up
6 Minute Hall-Walk Distance (Intent to Treat Cohort)
Measured: At 2-year follow-up
6 Minute Hall-Walk Distance (Per Protocol Cohort)
Measured: At 2-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startAug 2007
- Primary completionOct 2013
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Gerald Kaye, Study chair, Princess Alexandra Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461734
- Sponsor's protocol ID
- PROTECT-PACE Version 4
- Acronym
- PROTECT-PACE
- Status last verified
- Mar 2017
- First submitted
- 17 Apr 2007
- Last updated
- 25 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26517949Kosmala 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.
PubMed 25862716Saito 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.
PubMed 25666325Kaye 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.
PubMed 25189602
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT00461734
- Acronym / sponsor ID
- PROTECT-PACE / PROTECT-PACE Version 4
- Conditions
- Left Ventricular Dysfunction
- Keywords
- Right Ventricular High Septal Pacing, Right Ventricular Apical Pacing, Left Ventricular Dysfunction, Heart Block, Pacemaker, Atrial Fibrillation, Ejection Fraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Oct 2013 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Apr 2007 (estimated)
- Results
- Posted 25 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 heart's 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 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RV Apex | Active comparator | Other: RV lead placement site |
| RV High Septum | Experimental | Other: RV lead placement site |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RV lead placement sitePatients randomised to RV apical or high septal lead placement site | Other | RV Apex, RV High Septum |
Primary outcome
Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort).
Time frame: At 2-year follow-up
Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Per Protocol Cohort).
Time frame: At 2-year follow-up
12 secondary outcomes
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)
Time frame: At 2-year follow-up
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)
Time frame: At 2-year follow-up
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)
Time frame: At 5-years follow-up (study extension)
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)
Time frame: At 5-year follow-up (study extension)
Worsening of Heart Failure
Time frame: At 5-year follow-up (study extension)
All Cause Mortality
Time frame: At 5-year follow-up (study extension)
Incidence of Stroke
Time frame: At 5-year follow-up (study extension)
Brain Natriuretic Peptide Levels (Intent to Treat Cohort)
Time frame: At 2-year follow-up
Brain Natriuretic Peptide Levels (Per Protocol Cohort)
Time frame: At 2-year follow-up
Echocardiographic Measures of Left Ventricular Dyssynchrony
Time frame: At 2-year follow-up
6 Minute Hall-Walk Distance (Intent to Treat Cohort)
Time frame: At 2-year follow-up
6 Minute Hall-Walk Distance (Per Protocol Cohort)
Time frame: At 2-year follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26517949Saito 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.
- Derived from this study: PubMed 25862716Kosmala 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.
- Derived from this study: PubMed 25666325Saito 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.
- Derived from this study: PubMed 25189602Kaye 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Gerald Kaye study chair
Princess Alexandra Hospital
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RV lead placement site in people with Left Ventricular Dysfunction, run by Medtronic Cardiac Rhythm and Heart Failure at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United Kingdom, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort). (time frame: At 2-year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00461734, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017; AzTrials last refreshed its copy on 29 Oct 2026.