Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment

Status: Recruiting
Location: See all (45) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

• Bifascicular block with a pacing indication

• Trifascicular block with a pacing indication

• Wenckebach with a pacing indication

Locations
Other Locations
Ireland
Beacon Hospital
RECRUITING
Dublin
Slovenia
Univerisity Medical Centre Ljubljana
RECRUITING
Ljubljana
United Kingdom
Aberdeen Royal Infirmary
RECRUITING
Aberdeen
Queen's Hospital
RECRUITING
Barking
Good Hope Hospital
RECRUITING
Birmingham
Queen Elizabeth Hospital
RECRUITING
Birmingham
University Hospital Dorset
RECRUITING
Bournemouth
Royal SUSSEX County Hospital
RECRUITING
Brighton
Bristol Heart Institute
RECRUITING
Bristol
Royal Papworth Hospital
RECRUITING
Cambridge
St Richard's Hospital
RECRUITING
Chichester
University Hospital Coventry
RECRUITING
Coventry
Croydon
RECRUITING
Croydon
Royal Infirmary of Edinburgh
RECRUITING
Edinburgh
Victoria Hospital
RECRUITING
Fife Keith
Medway Maritime Hospital
RECRUITING
Gillingham
Wycombe Hospital
RECRUITING
High Wycombe
Forth Valley Royal Hospital
RECRUITING
Larbert
Leeds Teaching Hospital
RECRUITING
Leeds
Glenfield Hospital
RECRUITING
Leicester
Liverpool Heart and Chest Hospital
RECRUITING
Liverpool
Hammersmith Hospital
RECRUITING
London
Kettering Hospital
RECRUITING
London
King's College Hospital
RECRUITING
London
Royal Free London/ Barnet Hospital
RECRUITING
London
St Bartholomew's Hospital
RECRUITING
London
Watford General Hospital
RECRUITING
London
James Cook Hospital
RECRUITING
Middlesbrough
King's Mill Hospital
RECRUITING
Nottingham
Nottingham City Hospital
RECRUITING
Nottingham
John Radcliffe Hospital
RECRUITING
Oxford
Derriford Hospital
RECRUITING
Plymouth
Queen Alexandra Hospital
RECRUITING
Portsmouth
Royal Berkshire
RECRUITING
Reading
East Surrey
RECRUITING
Redhill
Rotherham General Hospital
RECRUITING
Rotherham
Northern General
RECRUITING
Sheffield
Wexham Park Hospital
RECRUITING
Slough
Southampton
RECRUITING
Southampton
Morriston Hospital
RECRUITING
Swansea
Great Western
RECRUITING
Swindon
Musgrove Park Hospital
RECRUITING
Taunton
Torbay Hospital
RECRUITING
Torquay
UHS Worthing
RECRUITING
Worthing
York Hospital
RECRUITING
York
Contact Information
Primary
Zachary Whinnett
z.whinnett@imperial.ac.uk
+447749576830
Backup
Daniel Keene
d.keene@imperial.ac.uk
+442075949776
Time Frame
Start Date: 2023-06-05
Estimated Completion Date: 2029-12-04
Participants
Target number of participants: 2600
Treatments
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: British Heart Foundation
Leads: Imperial College London

This content was sourced from clinicaltrials.gov