Rate or Rhythm Control in CRT: the RHYTHMIC Study

Recruiting now · Not applicable

Conditions studied: Atrial Fibrillation, Heart Failure

In brief

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.

Key facts

Study ID

NCT04664686

Run by

Guy's and St Thomas' NHS Foundation Trust

People needed

70

Starts

2021-10-19

Expected to finish

2027-09-30

Last updated by the study team

2026-01-26

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Guys and St Thomas' NHS Foundation Trust — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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