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

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

Plain Language Summary

Simplified for easier understanding

This study is comparing two strategies — controlling heart rate versus controlling heart rhythm — in people with heart failure who have a device called a cardiac resynchronization therapy (CRT) pacemaker. These patients also have atrial fibrillation (an irregular heartbeat) that is reducing how well their pacemaker works. Researchers want to find the best approach to manage this combination of conditions. **You may be eligible if you:** - Have heart failure with a weak left ventricle (pumping chamber) despite being on the best available medications - Have had a CRT pacemaker successfully implanted or upgraded - Have atrial fibrillation that is causing your pacemaker to work less than 95% of the time - Have been recommended by your doctor to have an AV node ablation (a procedure to control heart rate) **You may NOT be eligible if you:** - Have a life expectancy of less than 1 year - Have a blood clot in your heart - Have permanent atrial fibrillation - Have a mechanical heart valve replacement - Have severe peripheral vascular disease (poor circulation in the limbs) - Are pregnant, breastfeeding, or planning pregnancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAF catheter ablation

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

PROCEDUREAV node ablation

AV node ablation


Locations(1)

Guys and St Thomas' NHS Foundation Trust

London, United Kingdom

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NCT04664686


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