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โ† Trials
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Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades

RecruitingNAAges 18 Years - anyAllImperial College London
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In plain words

What the trial is, and whether it could suit you

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 contin

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing)
  • Continued RV Pacing (Right Ventricular Pacing)
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Where

12 sites
Royal Papworth Hospital
Cambridge, United Kingdom
St. Richard's Hospital - University Hospitals Sussex
Chichester, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust,
Coventry, United Kingdom
Croydon University Hospital - Croydon Health Services
Croydon, United Kingdom
Glenfield Hospital
Leicester, United Kingdom
Hammersmith Hospital
London, United Kingdom
King's College Hospital
London, United Kingdom
St Bartholomew's Hospital - Barts Health NHS Trust
London, United Kingdom

โ€ฆand 4 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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