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

Primary Purpose

Bradycardia, Pacing, Right Ventricular Pacing

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Pacemaker - Physiological pacing
Pacemaker - Right Ventricular pacing
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bradycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: Permanent or intermittent 3rd degree AV block Permanent or intermittent Mobitz type II AV block First Degree AV block with a pacing indication Slow chronic Atrial Fibrillation or Proposed AV node ablation Bifasciular block with a pacing indication Trifasicular block with a pacing indication Wenckebach with a pacing indication Exclusion Criteria: Patients who are likely to only need occasional ventricular pacing, i.e. those with isolated sick sinus syndrome. Pregnant women. Unable to provide informed consent. Those with comorbidity leading to a life expectancy <1year.

Sites / Locations

  • Hammersmith HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Right ventricular pacing

Physiological pacing

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Mortality
Death, any cause
Heart Failure Morbidity
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)
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.
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.
Safety endpoints: Device infections (requiring device extraction), pacing thresholds, need for lead revision or reimplantation, generator change, haematoma and pneumothorax
Pacemaker derived endpoints: a) Atrial fibrillation (duration >6minutes) b) Ventricular arrhythmia incidence c) Daily patient activity (hours stratified by device vendor)
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.
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.
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.
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
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.

Full Information

First Posted
February 13, 2023
Last Updated
September 18, 2023
Sponsor
Imperial College London
Collaborators
British Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05815745
Brief Title
"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)
Acronym
PROTECT-HF
Official Title
Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 5, 2023 (Actual)
Primary Completion Date
December 4, 2029 (Anticipated)
Study Completion Date
December 4, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
British Heart Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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. 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).
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia, Pacing, Right Ventricular Pacing, His Bundle Pacing, Left Bundle Branch Area Pacing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
2600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Right ventricular pacing
Arm Type
Active Comparator
Arm Description
Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice)
Arm Title
Physiological pacing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Pacemaker - Physiological pacing
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Pacemaker - Right Ventricular pacing
Intervention Description
Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice).
Primary Outcome Measure Information:
Title
Mortality
Description
Death, any cause
Time Frame
From date of consent, until date of death from any cause, assessed up until 78 months.
Title
Heart Failure Morbidity
Description
Adjudicated unplanned heart failure acute care (hospital admissions or ambulatory diuretic therapy i.e. diuretic lounge visit).
Time Frame
From date of consent, assessed up until 78 months, or death from any cause, whichever came first.
Secondary Outcome Measure Information:
Title
Incidence of clinically indicated upgrade to conventional biventricular pacing (CRT device)
Time Frame
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.
Title
Patient quality of life assessed via questionnaires (EQ-5D-5L) EQ-5D is the name of the instrument and is not an acronym.
Description
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.
Time Frame
From date of consent, assessed up to 78 months or until death of any cause, whichever came first.
Title
Patient symptoms assessed on a scale of 0-100 monthly
Description
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.
Time Frame
From one month after device implant date, assessed up to 78 months or until death of any cause, whichever came first.
Title
Safety endpoints: Device infections (requiring device extraction), pacing thresholds, need for lead revision or reimplantation, generator change, haematoma and pneumothorax
Time Frame
From device implant date, assessed up to 78 months or until death of any cause, whichever came first.
Title
Pacemaker derived endpoints: a) Atrial fibrillation (duration >6minutes) b) Ventricular arrhythmia incidence c) Daily patient activity (hours stratified by device vendor)
Time Frame
From device implant date, assessed up to 78 months or until death of any cause, whichever came first.
Title
Patient quality of life assessed via questionnaires '36-Item Short Form Health Survey' (SF-36)
Description
A high score defines a more favourable health state. Range 0 to 100.
Time Frame
From date of consent, assessed up to 78 months or until death of any cause, whichever came first.
Title
Echo Sub-Study Endpoint: Left Ventricular End Systolic Volume (LVESV) (>10mls) within group differences
Description
Within group differences of Left Ventricular End Systolic Volume (>10mls) for differences according to treatment allocation.
Time Frame
From baseline echocardiogram (0 to 6 weeks post pacemaker implant) to follow-up echocardiogram (24±1 months post pacemaker implant).
Title
Echo Sub-Study Endpoint: Ejection Fraction (EF) within patient changes
Description
Within patient changes in Ejection Fraction will be assessed for differences according to treatment allocation.
Time Frame
From baseline echocardiogram (0 to 6 weeks post pacemaker implant) to follow-up echocardiogram (24±1 months post pacemaker implant).
Title
Echo Sub-Study Endpoint: Left Ventricular End Systolic Volume (LVESV) (>10mls) within patient changes
Description
Within patient changes of Left Ventricular End Systolic Volume (>10mls) for differences according to treatment allocation
Time Frame
From baseline echocardiogram (0 to 6 weeks post pacemaker implant) to follow-up echocardiogram (24±1 months post pacemaker implant).
Title
Echo Sub-Study Endpoint: Ejection Fraction (EF) within group differences
Description
Within group differences in Ejection Fraction will be assessed for differences according to treatment allocation.
Time Frame
From baseline echocardiogram (0 to 6 weeks post pacemaker implant) to follow-up echocardiogram (24±1 months post pacemaker implant).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Permanent or intermittent 3rd degree AV block Permanent or intermittent Mobitz type II AV block First Degree AV block with a pacing indication Slow chronic Atrial Fibrillation or Proposed AV node ablation Bifasciular block with a pacing indication Trifasicular block with a pacing indication Wenckebach with a pacing indication Exclusion Criteria: Patients who are likely to only need occasional ventricular pacing, i.e. those with isolated sick sinus syndrome. Pregnant women. Unable to provide informed consent. Those with comorbidity leading to a life expectancy <1year.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zachary Whinnett
Phone
+447749576830
Email
z.whinnett@imperial.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Keene
Phone
+442075949776
Email
d.keene@imperial.ac.uk
Facility Information:
Facility Name
Hammersmith Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nandita Kaza
Email
n.kaza@imperial.ac.uk

12. IPD Sharing Statement

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

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