Health TrialsbyHealthPanel

Rate or Rhythm Control in CRT: the RHYTHMIC Study

ConditionsAtrial FibrillationHeart Failure
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • AF catheter ablation

    Procedure/Surgery

    Isolation of all four pulmonary veins and additional lesions, considered indicated by the operator

  • AV node ablation

    Procedure/Surgery

    AV node ablation

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: AF catheter ablationActive comparator 1 intervention
Group B: AV node ablationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Difference in ejection fraction

On 2D echocardiography

Time frame
6 months

Secondary outcomes

1

Difference in left ventricular end systolic volume

On 2D echocardiography

Time frame
6 months
2

Difference in biventricular pacing percentage

On pacemaker check

Time frame
6 months
3

Difference in quality of life

Assessed by Packer's Clinical Composite Score

Time frame
6 months
4

Difference in NYHA class

On clinical assessment

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guy's and St Thomas' NHS Foundation Trust

Lead sponsor

King's College London

Collaborator

Source ClinicalTrials.gov
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