Rate or Rhythm Control in CRT: the RHYTHMIC Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorGuy's and St Thomas' NHS Foundation Trust
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Life expectancy <1 year
Presence of atrial or ventricular thrombus
Permanent atrial fibrillation
Mechanical aortic valve replacement
Trial design
Treatments tested in this trial
- AF catheter ablation
- AV node ablation
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Guy's and St Thomas' NHS Foundation Trust
Lead sponsor
King's College London
Collaborator
Source ClinicalTrials.gov