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
Inclusion
- 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
Exclusion
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