- Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades — Recruiting • Non-phase study • Cardiology / Cardiovascular • NCT06052475.
- What is being tested: Comparison of physiological pacing strategies versus traditional right ventricular (RV) pacing in patients undergoing first-time pacemaker implantation, specifically evaluating whether modern pacing approaches reduce RV pacing-induced cardiomyopathy.
- Patient eligibility overview: Patients requiring first-time pacemaker implantation who have bradycardia indications, including those with only mildly impaired cardiac function who would traditionally receive standard RV pacing.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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…
- 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
- Patient reported decline in functional class or exercise tolerance
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.