Rate or Rhythm Control in CRT: the RHYTHMIC Study (NCT04664686) | Clinical Trial Compass
RecruitingNot Applicable
Rate or Rhythm Control in CRT: the RHYTHMIC Study
United Kingdom70 participantsStarted 2021-10-19
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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