Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorImperial College London
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
EF reduced by >5% of increase in LVESV by 10ml since implant
NT-proBNP >250ng/L in sinus rhythm
NT-proBNP > 750 Ng/L if AF
Left atrial volume index > 30ml/m2
Disqualifiers
Those unable to provide informed consent
Patients under age 18
Pregnant women
Trial design
Design model
Crossover
Treatments tested in this trial
Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing)
DeviceThe 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.
Continued RV Pacing (Right Ventricular Pacing)
DeviceRight ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice).
Treatment groups
155 Participants
are divided into 2 treatment groupsGroup A: Physiological Pacing (Conduction System Pacing or Biventricular Pacing)Experimental treatment 1 intervention
Group B: Right Ventricular PacingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
SF-36 (Short Form 36 Health Survey Questionnaire) Physical Component Summary
Time frame
From date of baseline, until end of trial follow-up at fourteen months post-baselineSecondary outcomes
1
Left ventricular ejection fraction
(% ejection fraction)
Time frame
From date of baseline, until end of trial follow-up at fourteen months2
Left ventricular end systolic volume
(millilitres)
Time frame
From date of baseline, until end of trial follow-up at fourteen months3
Minnesota Living with Heart Failure Questionnaire
Time frame
From date of baseline, until end of trial follow-up at fourteen months4
Six-minute walk test
Measured in distance in metres
Time frame
From date of baseline, until end of trial follow-up at fourteen monthsSponsors and contacts
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Source ClinicalTrials.gov