NCT04664686 Rate or Rhythm Control in CRT: the RHYTHMIC Study
| NCT ID | NCT04664686 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2021-10-19 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2021-10-19 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Christopher A Rinaldi
PRINCIPAL INVESTIGATOR
Guy's and St Thomas' NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT04664686 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04664686 currently recruiting?
Yes, NCT04664686 is actively recruiting participants. Contact the research team at aldo.rinaldi@kcl.ac.uk for enrollment information.
Where is the NCT04664686 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT04664686 clinical trial?
NCT04664686 is sponsored by Guy's and St Thomas' NHS Foundation Trust. The principal investigator is Christopher A Rinaldi at Guy's and St Thomas' NHS Foundation Trust. The trial plans to enroll 70 participants.
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