Left Ventricular Dysfunction Clinical Trial
— PROTECT-PACEOfficial 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.
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.
Status | Active, not recruiting |
Enrollment | 248 |
Est. completion date | August 2015 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Calvary Wakefield Hospital | Adelaide | South Australia |
Australia | Flinders Medical Center | Adelaide | South Australia |
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | Princess Alexandra Hospital | Brisbane | Queensland |
Australia | Royal Brisbane & Womens' Hospital | Brisbane | Queensland |
Australia | The Prince Charles Hospital | Brisbane | Queensland |
New Zealand | Auckland City Hospital | Auckland | |
New Zealand | Christchurch Hospital | Christchurch | |
United Kingdom | 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 |
Lead Sponsor | Collaborator |
---|---|
Medtronic Cardiac Rhythm Disease Management |
Australia, New Zealand, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of change in Left Ventricular Ejection Fraction from baseline to 2 years. | At 2-year follow-up | No | |
Secondary | Incidence of atrial tachyarrhythmia recorded by the pacemakers | At 2-year follow-up; and at 5-year follow-up (study extension) | No | |
Secondary | 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. |
At 2-year follow-up; and at 5-year follow-up (study extension) | No |
Secondary | All cause mortality | At 2-year follow-up; and at 5-year follow-up (study extension) | No | |
Secondary | Incidence of stroke | At 2-year follow-up | No | |
Secondary | N-Terminal Brain Natriuretic Peptide (NT-proBNP) levels | At 2-year follow-up | No | |
Secondary | Echocardiographic measures of left ventricular dyssynchrony | At 2-year follow-up | No | |
Secondary | 6 minute Hall-Walk distance | At 2-year follow-up | No |
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