Rate or Rhythm Control in CRT: the RHYTHMIC Study
Recruiting · NCT04664686 · Interventional (participants receive a specific treatment) · Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
View the official record on ClinicalTrials.gov →Interventions studied
AF catheter ablationAV node ablation
What this trial is about
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 take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed.
- Guys and St Thomas' NHS Foundation Trust - London, United Kingdom
- Guys and St Thomas' NHS Foundation Trust - London, United Kingdom