"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)
Study Details
Study Description
Brief Summary
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 size with 85% power. A total of 2600 patients will be recruited to allow for patient drop-out and crossover.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Patients entering the study will attend for implantation of a pacemaker device and be randomised to either right ventricular pacing or physiological pacing.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Right ventricular pacing Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice) |
Device: Pacemaker - Right Ventricular pacing
Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice).
|
| Experimental: Physiological pacing The approach for physiological pacing will be either His bundle pacing or left bundle pacing at the operator's discretion. If both of these are not achieved biventricular pacing will be performed. |
Device: Pacemaker - Physiological pacing
The approach for physiological pacing will be either His bundle pacing or left bundle pacing at the operator's discretion. If both of these are not achieved biventricular pacing will be performed.
|
Outcome Measures
Primary Outcome Measures
- Mortality [From date of consent, until date of death from any cause, assessed up until 78 months.]
Death, any cause
- Heart Failure Morbidity [From date of consent, assessed up until 78 months, or death from any cause, whichever came first.]
Adjudicated unplanned heart failure acute care (hospital admissions or ambulatory diuretic therapy i.e. diuretic lounge visit).
Secondary Outcome Measures
- Incidence of clinically indicated upgrade to conventional biventricular pacing (CRT device) [From date of randomisation until the date of first documented incident of device upgrade, or death from any cause, whichever came first, assessed up to 78 months.]
- Patient quality of life assessed via questionnaires (EQ-5D-5L) EQ-5D is the name of the instrument and is not an acronym. [From date of consent, assessed up to 78 months or until death of any cause, whichever came first.]
The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ 'visual analogue scale' (EQ VAS). The descriptive system is made up of 5 sections: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. A High score on the descriptive section means a worse health outcome. A Low score on the descriptive section means a better health outcome. A value set is required to convert the outcomes into scores. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative (numerical) measure of health outcome that reflect the patient's own judgement. A high score on the VAS means a better outcome. A low score on the VAS means a worse outcome.
- Patient symptoms assessed on a scale of 0-100 monthly [From one month after device implant date, assessed up to 78 months or until death of any cause, whichever came first.]
This questionnaire will be sent to participants on a monthly basis for the duration of the study, 78 months from one month post pacemaker implant until end of study (78 months) or death from any cause, whichever came first.
- Safety endpoints: Device infections (requiring device extraction), pacing thresholds, need for lead revision or reimplantation, generator change, haematoma and pneumothorax [From device implant date, assessed up to 78 months or until death of any cause, whichever came first.]
- Pacemaker derived endpoints: a) Atrial fibrillation (duration >6minutes) b) Ventricular arrhythmia incidence c) Daily patient activity (hours stratified by device vendor) [From device implant date, assessed up to 78 months or until death of any cause, whichever came first.]
- Patient quality of life assessed via questionnaires '36-Item Short Form Health Survey' (SF-36) [From date of consent, assessed up to 78 months or until death of any cause, whichever came first.]
A high score defines a more favourable health state. Range 0 to 100.
Eligibility Criteria
Criteria
We will recruit patients who are referred for clinically indicated pacemaker implantation
Inclusion Criteria:
- Adults aged over 18 with left ventricular ejection fraction >35% and one or more of the following guideline based ventricular pacing indications:
- Permanent or intermittent 3rd degree AV block e) Permanent or intermittent Mobitz type II AV block f) First Degree AV block (>230ms) with a pacing indication g) Slow chronic Atrial Fibrillation or Proposed AV node ablation
Exclusion Criteria:
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Patients who are likely to only need occasional ventricular pacing, i.e. those with isolated sick sinus syndrome.
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Pregnant women.
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Unable to provide informed consent.
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Those with comorbidity leading to a life expectancy <1year.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Imperial College London
- British Heart Foundation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22HH7931