Status:
RECRUITING
Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades
Lead Sponsor:
Imperial College London
Conditions:
Pacing-Induced Cardiomyopathy
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
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:
- 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
Key Trial Info
Start Date :
September 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT06052475
Start Date
September 25 2023
End Date
August 31 2026
Last Update
September 19 2024
Active Locations (12)
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1
Royal Papworth Hospital
Cambridge, United Kingdom
2
St. Richard's Hospital - University Hospitals Sussex
Chichester, United Kingdom
3
University Hospitals Coventry and Warwickshire NHS Trust,
Coventry, United Kingdom
4
Croydon University Hospital - Croydon Health Services
Croydon, United Kingdom