Status:
RECRUITING
Rate or Rhythm Control in CRT: the RHYTHMIC Study
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Collaborating Sponsors:
King's College London
Conditions:
Atrial Fibrillation
Heart Failure
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
70 patients with heart failure, AF and CRT with BiV\<95% will be randomised to either AF ablation or AV node ablation. Evaluation at 6 months with echocardiography and clinical assessment.
Detailed Description
70 patients with heart failure, AF and CRT with BiV\<95% will be recruited from outpatient clinic, pacing clinic or inpatient wards. Patients will be consented and will undergo baseline investigation ...
Eligibility Criteria
Inclusion
- Ability to provide informed consent to participate and willing to comply with the clinical investigation plan and follow-up schedule.
- QRS duration \>120ms on surface ECG, severe left ventricular systolic impairment (EF≤35%) and clinical symptoms of heart failure despite optimum medical therapy (NYHA class II-IV) at time of CRT implant or upgrade
- Successful CRT implant or upgrade including atrial lead
- Biventricular pacing percentage \<95% secondary to atrial fibrillation at least 3 months post implant or upgrade
- Clinically indicated for AV node ablation
Exclusion
- Life expectancy \<1 year
- Presence of atrial or ventricular thrombus
- Permanent atrial fibrillation
- Mechanical aortic valve replacement
- Severe peripheral vascular disease
- Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
- Participation in other studies with active treatment / investigational arm
Key Trial Info
Start Date :
October 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 29 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04664686
Start Date
October 19 2021
End Date
August 29 2026
Last Update
May 6 2024
Active Locations (1)
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1
Guys and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH