NCT Number: NCT06052475
Guidelines for patients having first-time implants advocate that even when heart function is only mildly impaired, modern pacing approaches should be utilised to avoid the potentially damaging effects of RV pacing to preventing symptoms from pacing induced or worsened cardiomyopathy.
However, once a traditional (RV) pacemaker is implanted, development of impaired heart function does not prompt a device upgrade. Even at the end of battery life, physicians simply replace it like-for-like.
This trial tests whether such patients have better symptoms and quality of life if changed to a modern physiological pacing strategy from the traditional RV pacing approach.
In this crossover trial, participants will be upgraded to a physiological pacing strategy.
After their procedure, they will have a one-month run-in period to recover from the procedure (their pacemaker will be programmed to continued RV pacing).
They will be have 2 one-month blinded time periods, randomised to physiological pacing or right ventricular pacing alternately. They will subsequently undergo two six-month blinded randomised time periods.
Patients will document symptoms monthly on a mobile phone application or computer. At the end of each time period, they will have measurements of heart function, a walking test and quality-of-life questionnaires including the SF-36 questionnaire.
The investigators hypothesise that upgrading to physiological pacing strategies will improve patients' quality of life.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Royal Papworth Hospital, Cambridge, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patients with an RV pacemaker and LVEF 35-50% and a high burden of right ventricular pacing (>40%) who are clinically indicated for a cardiac resynchronisation therapy upgrade procedure and:
Exclusion criteria
The approach for physiological pacing upgrade 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.
Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice).
Time frame: From date of baseline, until end of trial follow-up at fourteen months post-baseline
Time frame: From date of baseline, until end of trial follow-up at fourteen months
(% ejection fraction)
Time frame: From date of baseline, until end of trial follow-up at fourteen months
(millilitres)
Time frame: From date of baseline, until end of trial follow-up at fourteen months
Time frame: From date of baseline, until end of trial follow-up at fourteen months
Measured in distance in metres
Time frame: From date of baseline, until end of trial follow-up at fourteen months
(atrial fibrillation percentage burden as measured by pacemaker device - %)
Time frame: At 2 months following baseline and 14 months following baseline visit
Time frame: From date of baseline, until end of trial follow-up at fourteen months post-baseline visit
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.
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 baseline, until end of trial follow-up at fourteen months post-baseline visit
This questionnaire will be sent to participants on a monthly basis for the duration of the study
Time frame: From device implant date, assessed up to 15 months at the end of the trial (including a one-month run-in period post-procedure prior to the first baseline visit)
Device infections (requiring device extraction), pacing thresholds, need for lead revision or reimplantation, generator change, haematoma and pneumothorax
Time frame: From date of baseline, until end of trial follow-up at fourteen months post baseline visit
Time frame: From date of baseline, until end of trial follow-up at fourteen months post baseline visit
Time frame: From date of baseline, until end of trial follow-up at fourteen months post baseline visit
B-type natriuretic peptide blood test
Contact information is provided by the study sponsor or research team.
Aya Khalil
CONTACT
Nandita Kaza, MRCP
CONTACT
Imperial College London
Other
Acronym: PROTECT-UP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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