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"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)

RecruitingNAAges 18 Years - anyAllImperial College London
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In plain words

What the trial is, and whether it could suit you

The PROTECT-HF multi-centre randomised controlled trial will compare two different pacing approaches for treating patients with slow heart rates. In it the investigators will compare a long-standing standard approach for pacing; right ventricular pacing, with a new form of pacing, physiological pacing (His and Left bundle area pacing) in 2600 patients. Patients will be allocated at random to receive either right ventricular pacing or physiological pacing. Endpoint measurements will be undertaken at baseline, and at six-monthly intervals post-randomisation. Treatment allocation will be blinded to the endpoint assessor and the patient. Recruitment and pacemaker implantation will be carried out at each participating centre. The primary analysis will be intention to treat. The investigators will also perform an on-treatment analysis. 2048 patients are needed to detect the expected effect

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
We will recruit patients who are referred for clinically indicated pacemaker implantation Inclusion Criteria: 1\. Adults aged over 18 with left ventricular ejection fraction \>35% and one or more of the following guideline based ventricular pacing indications: 1. Permanent or intermittent 3rd degree AV block 2. Permanent or intermittent Mobitz type II AV block 3. First Degree AV block with a pacing indication 4. Slow chronic Atrial Fibrillation or Proposed AV node ablation 5. Bifascicular block with a pacing indication 6. Trifascicular block with a pacing indication 7. Wenckebach with a pacing indication Exclusion Criteria: 1. Patients who are likely to only need occasional ventricular pacing, i.e. those with isolated sick sinus syndrome. 2. Pregnant women. 3. Unable to provide informed consent. 4. Those with comorbidity leading to a life expectancy \<1year.
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What it tests

  • Pacemaker - Physiological pacing
  • Pacemaker - Right Ventricular pacing
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Where

45 sites
Beacon Hospital
Dublin, Ireland
Univerisity Medical Centre Ljubljana
Ljubljana, Slovenia
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Queen's Hospital
Barking, United Kingdom
Good Hope Hospital
Birmingham, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
University Hospital Dorset
Bournemouth, United Kingdom
Royal SUSSEX County Hospital
Brighton, United Kingdom

โ€ฆand 37 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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