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Active CLINICAL STUDY Europe PMC

PROTECT-HF: Physiological Vs Right ventricular pacing Outcome Trial Evaluated for bradyCardia Treatment

£168.96M GBP

Funder British Heart Foundation
Recipient Organization Imperial College London
Country United Kingdom
Start Date Jun 05, 2023
End Date Dec 04, 2029
Duration 2,374 days
Number of Grantees 1
Roles Award Holder
Data Source Europe PMC
Grant ID CS/F/21/190036
Grant Description

Right ventricular (RV) pacing prevents bradycardia and saves lives immediately, but in the long term can cause Left Ventricular (LV) dysfunction and consequent mortality and Heart Failure morbidity.

Physiological pacing aims to minimize the abnormality of ventricular activation caused by right ventricular pacing, and thereby protect patients receiving anti-bradycardia pacing from excessive long-term mortality and morbidity.

The physiological pacing lead is carefully positioned to directly stimulate the highly specialised His-Purkinjee fibres (His bundle or left bundle), thereby achieving a more normal ventricular activation pattern. Observational studies show that physiological pacing is technically feasible and clinically safe.

Their follow-up data suggest better preservation of LV function and lower risk of death and Heart Failure. PROTECT-HF will test this for the first time in an RCT.

It will be a multicentre blinded trial randomising 2600 patients with a bradycardia indication for pacing and ejection fraction >35%.

It will assess death and heart failure as the primary endpoint, and blinded Heart Failure symptoms as an important secondary endpoint.

This landmark trial will establish whether physiological pacing (which has no extra device cost) would be beneficial to the ~40,000 UK patients a year receiving a bradycardia pacemaker.

All Grantees

Imperial College London

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