Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades
Recruiting
N/AInterventional Study
Pacing-Induced CardiomyopathyHeart Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
155 (estimated)
Sponsor
Imperial College London · Other
Who this trial is looking for
This trial is looking for patients who have a specific type of heart pacemaker and experience heart failure symptoms. Participants will switch to a different pacing method and share their symptoms over time to see if it improves their quality of life.
Are You a Good Fit for This Trial?
Must be takingLoop diuretics
You may be able to join if
I have a pacemaker implanted in my right ventricle.
I have heart failure with reduced left ventricular function.
I have been experiencing symptoms related to pacing.
I have been taking diuretics regularly.
I have a decline in my daily activities.
I have had a decrease in my heart function since my pacemaker was implanted.
My heart function test results meet the trial's criteria.
You may not be able to join if
I cannot provide informed consent.
I am under 18 years old.
I am pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
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Eligibility Criteria
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:
1. EF reduced by \>5% of increase in LVESV by 10ml since implant
2. NT-proBNP \>250ng/L in sinus rhythm
3. …
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:
1. EF reduced by \>5% of increase in LVESV by 10ml since implant
2. NT-proBNP \>250ng/L in sinus rhythm
3. NT-proBNP \> 750 Ng/L if AF
4. Left atrial volume index \> 30ml/m2
5. Regular loop diuretics prescribed
6. Decline in daily patient activity by \>1 hour per day since implant
7. Decrease in device measured thoracic impedance
8. Patient reported decline in functional class or exercise tolerance
Exclusion Criteria:
* Those unable to provide informed consent
* Patients under age 18
* Pregnant women
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