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Rate or Rhythm Control in CRT: the RHYTHMIC Study

RECRUITINGN/ASponsored by Guy's and St Thomas' NHS Foundation Trust
Actively Recruiting
PhaseN/A
SponsorGuy's and St Thomas' NHS Foundation Trust
Started2021-10-19
Est. completion2027-09-30
Eligibility
Age18 Years – 85 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04664686

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

Age: 18 Years – 85 YearsHealthy volunteers accepted
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

Conditions3

Atrial FibrillationHeart DiseaseHeart Failure

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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