Primary endpoint of double-Blinded, Placebo-Controlled Interventional Study for Assessing Catheter Ablation Efficacy in Persistent Atrial Fibrillation was patient blinding; randomized in a 1:1 ratio
to receive either PVI±DCCV(PVI group) or DCCV+Placebo(DCCV group); looked at 20 patients in pilot for blinding, found RCT feasibility for blinded placebo-controlled trial & place had higher recurrence
Why this study? ‘there are no randomised, double-blinded clinical trials comparing catheter ablation to DC-cardioversion(DCCV) with medical therapy in patients with persistent atrial fibrillation(PersAF).’ ‘conducted a pilot study to evaluate the feasibility of conducting a definitive placebo-controlled trial.’
‘During the study, 35% of patients experienced recurrence of PersAF prior to completion of 12 months follow-up. Blinding was successfully maintained amongst both patients and medical staff.
The DCCV group had a trend to higher recurrence and repeat procedure rate compared to the PVI group (recurrence of PersAF 60 %vs 30%; p=0.07 and repeat procedure 70% vs 40%;p=0.4). The quality of life experienced by individuals in the PVI group showed improvement, as evidenced by enhanced scores on the AF specific questionnaire [AF PROMS] [3(±4) vs 21(±8)] and SF-12 mental-component raw score [51.4(±7) vs 43.24(±15)] in patients who maintained sinus rhythm at 12 months.’
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