Actively Recruiting
Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades
Led by Imperial College London · Updated on 2024-09-19
155
Participants Needed
12
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades
Who Can Participate
Eligibility Criteria
You may qualify if you...
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:
- 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
- Regular loop diuretics prescribed
- Decline in daily patient activity by >1 hour per day since implant
- Decrease in device measured thoracic impedance
- Patient reported decline in functional class or exercise tolerance
Exclusion Criteria:
- Those unable to provide informed consent
- Patients under age 18
- Pregnant women
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
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Trial Site Locations
Total: 12 locations
1
Royal Papworth Hospital
Cambridge, United Kingdom
Actively Recruiting
2
St. Richard's Hospital - University Hospitals Sussex
Chichester, United Kingdom
Actively Recruiting
3
University Hospitals Coventry and Warwickshire NHS Trust,
Coventry, United Kingdom
Actively Recruiting
4
Croydon University Hospital - Croydon Health Services
Croydon, United Kingdom
Actively Recruiting
5
Glenfield Hospital
Leicester, United Kingdom
Actively Recruiting
6
Hammersmith Hospital
London, United Kingdom
Actively Recruiting
7
King's College Hospital
London, United Kingdom
Actively Recruiting
8
St Bartholomew's Hospital - Barts Health NHS Trust
London, United Kingdom
Actively Recruiting
9
Oxford University Hospitals
Oxford, United Kingdom
Actively Recruiting
10
University Hospitals Southampton
Southampton, United Kingdom
Actively Recruiting
11
Great Western Hospitals
Swindon, United Kingdom
Actively Recruiting
12
Worthing Hospital - University Hospitals Sussex
Worthing, United Kingdom
Actively Recruiting
Research Team
A
Aya Khalil
CONTACT
N
Nandita Kaza, MRCP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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