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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05815745
Other study ID # 22HH7931
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 5, 2023
Est. completion date December 4, 2029

Study information

Verified date March 2024
Source Imperial College London
Contact Zachary Whinnett
Phone +447749576830
Email z.whinnett@imperial.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. 500-patient sub-study will assess within patient, and between groups, echocardiographic changes over a 24-month period to try and improve mechanistic understanding of PICM (Pacing Induced Cardiomyopathy).


Description:

Patients entering the study will attend for implantation of a pacemaker device and be randomised to either right ventricular pacing or physiological pacing. Patients at sites participating in echo sub-study will be informed of and given opportunity to consent to echo sub-study, this will be optional to them, even if they have consented to the main study.


Recruitment information / eligibility

Status Recruiting
Enrollment 2600
Est. completion date December 4, 2029
Est. primary completion date December 4, 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. Bifasciular block with a pacing indication 6. Trifasicular 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.

Study Design


Intervention

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.
Pacemaker - Right Ventricular pacing
Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice).

Locations

Country Name City State
United Kingdom University Hospital Dorset Bournemouth
United Kingdom Royal SUSSEX County Hospital Brighton
United Kingdom St Richard's Hospital Chichester
United Kingdom University Hospital Coventry Coventry
United Kingdom Croydon Croydon
United Kingdom Victoria Hospital Fife Keith
United Kingdom Medway Maritime Hospital Gillingham
United Kingdom Wycombe Hospital High Wycombe
United Kingdom Forth Valley Royal Hospital Larbert
United Kingdom Leeds Teaching Hospital Leeds
United Kingdom Glenfield Hospital Leicester
United Kingdom Liverpool Heart and Chest Hospital Liverpool
United Kingdom Hammersmith Hospital London
United Kingdom Kettering Hospital London
United Kingdom King's College Hospital London
United Kingdom Royal Free London/ Barnet Hospital London
United Kingdom St Bartholomew's Hospital London
United Kingdom Watford General Hospital London
United Kingdom James Cook Hospital Middlesbrough
United Kingdom King's Mill Hospital Nottingham
United Kingdom Nottingham City Hospital Nottingham
United Kingdom John Radcliffe Hospital Oxford
United Kingdom Royal Berkshire Reading
United Kingdom East Surrey Redhill
United Kingdom Rotherham General Hospital Rotherham
United Kingdom Northern General Sheffield
United Kingdom Southampton Southampton
United Kingdom Morriston Hospital Swansea
United Kingdom Great Western Swindon
United Kingdom UHS Worthing Worthing

Sponsors (2)

Lead Sponsor Collaborator
Imperial College London British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality Death, any cause From date of consent, until date of death from any cause, assessed up until 78 months.
Primary Heart Failure Morbidity Adjudicated unplanned heart failure acute care (hospital admissions or ambulatory diuretic therapy i.e. diuretic lounge visit). From date of consent, assessed up until 78 months, or death from any cause, whichever came first.
Secondary 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.
Secondary Patient quality of life assessed via questionnaires (EQ-5D-5L) EQ-5D is the name of the instrument and is not an acronym. 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.
From date of consent, assessed up to 78 months or until death of any cause, whichever came first.
Secondary Patient symptoms assessed on a scale of 0-100 monthly 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. From one month after device implant date, assessed up to 78 months or until death of any cause, whichever came first.
Secondary 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.
Secondary 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.
Secondary Patient quality of life assessed via questionnaires '36-Item Short Form Health Survey' (SF-36) A high score defines a more favourable health state. Range 0 to 100. From date of consent, assessed up to 78 months or until death of any cause, whichever came first.
Secondary Echo Sub-Study Endpoint: Left Ventricular End Systolic Volume (LVESV) (>10mls) within group differences Within group differences of Left Ventricular End Systolic Volume (>10mls) for differences according to treatment allocation. From baseline echocardiogram (0 to 6 weeks post pacemaker implant) to follow-up echocardiogram (24±1 months post pacemaker implant).
Secondary Echo Sub-Study Endpoint: Ejection Fraction (EF) within patient changes Within patient changes in Ejection Fraction will be assessed for differences according to treatment allocation. From baseline echocardiogram (0 to 6 weeks post pacemaker implant) to follow-up echocardiogram (24±1 months post pacemaker implant).
Secondary Echo Sub-Study Endpoint: Left Ventricular End Systolic Volume (LVESV) (>10mls) within patient changes Within patient changes of Left Ventricular End Systolic Volume (>10mls) for differences according to treatment allocation From baseline echocardiogram (0 to 6 weeks post pacemaker implant) to follow-up echocardiogram (24±1 months post pacemaker implant).
Secondary Echo Sub-Study Endpoint: Ejection Fraction (EF) within group differences Within group differences in Ejection Fraction will be assessed for differences according to treatment allocation. From baseline echocardiogram (0 to 6 weeks post pacemaker implant) to follow-up echocardiogram (24±1 months post pacemaker implant).
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