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Compares treatment options for Pacing-Induced Cardiomyopathy
Official title Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades
ClinicalTrials.gov ID: NCT06052475
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- Those unable to provide informed consent
- Patients under age 18
- Pregnant women
See the full 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
- Those unable to provide informed consent
- Patients under age 18
- Pregnant women
The study team makes the final eligibility decision.
Where it's taking place
- Cambridge, United Kingdom
- Chichester, United Kingdom
- Coventry, United Kingdom
- Croydon, United Kingdom
- Leicester, United Kingdom
- London, United Kingdom
- Oxford, United Kingdom
- Southampton, United Kingdom
- Swindon, United Kingdom
- Worthing, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cambridge, United Kingdom; Chichester, United Kingdom; Coventry, United Kingdom; Croydon, United Kingdom; Leicester, United Kingdom; London, United Kingdom and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.