RecruitingNot ApplicableNCT04664686

Rate or Rhythm Control in CRT: the RHYTHMIC Study

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrollment

70 participants

Start Date

Oct 19, 2021

Study Type

INTERVENTIONAL

Conditions

Heart Failure Atrial Fibrillation

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria5

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 Criteria7

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