In our centre, we planning to conduct a randomised VT trial in high risk ishaemic HF (EF < 40%) patients with primary prevention ICD indication. We plan to include aprox. 60 pts (30 ablation + ICD arm and 30 ICD + medical therapy arm). Our main focus would be reduction of appropriate ICD therapy, progression of HF and QoL.
Dear David,
please excuse if I have misunderstood your obejectives. You state that the main focus would be "reduction of appropriate ICD therapy", but you randomise both groups to this factor. How could you ever determine a difference in this respect with such design?
Then to your question: When focusing on "high risk" and "EF
Perhaps incidence of appropriate ICD therapies for either VT or VF might be the most appropriate primary endpoint for your study. Presumably your hypothesis would be that the primary endpoint would occur less frequently in the 'Ablation and ICD' than the 'Medical Therapy and ICD' arm. You can get an estimate the occurrence of this endpoint from the results in this study:
Article Long-term follow-up of primary and secondary prevention impl...
The hypothesis is catheter ablation is superior to aggressive antiarrhythmic drug therapy for VT.
In clinical trial to compare two management strategies for patients with ischemic heart disease and ICD therapy the primary endpoint may be a composite of appropriate ICD shocks or SCD.
BR
Hi, David,, number of appropriate VT shock will be an important endpoint. Also you can analyze the number of asymptomatic VT and pattern of VT (monomorphic or polymorphic) from ICD memory in both groups and it's effect on progession of LV dysfunction. Thanks...
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