First-line Cryoablation for Early Treatment of Persistent Atrial Fibrillation

A vizsgálat adatai

Ki végzi

Region Örebro County

Azonosító

NCT05939076EU 2023-505962-28-00

A regiszteradat frissítve

2023. július 11.

Eredeti leírás

The goal of this multicentre, prospective, randomized, open, blinded for evaluation of end point (PROBE) controlled parallel-group superiority trial, is to compare the efficacy of antiarrhythmic drug (AAD) therapy and cryoballoon pulmonary vein isolation (PVI) regarding freedom from atrial fibrillation (%) assessed by an implantable cardiac monitor (ICM), ECG tracing or Holter at 12 months in patients with persistent AF. The main question[s] it aims to answer are:A teljes eredeti leírásKevesebb

First-line Cryoablation for Early Treatment of Persistent Atrial Fibrillation - a Randomized Study Comparing Early Trigger Isolation Using the Cryoballoon Versus Antiarrhythmic Medication

The goal of this multicentre, prospective, randomized, open, blinded for evaluation of end point (PROBE) controlled parallel-group superiority trial, is to compare the efficacy of antiarrhythmic drug (AAD) therapy and cryoballoon pulmonary vein isolation (PVI) regarding freedom from atrial fibrillation (%) assessed by an implantable cardiac monitor (ICM), ECG tracing or Holter at 12 months in patients with persistent AF. The main question[s] it aims to answer are:

* Will first-line cryoballoon ablation for PVI compared to AAD, result in 25 % higher freedom from atrial tachyarrhythmias lasting > 6 minutes at 12 months (primary outcome) excluding three months initial blanking period, in patients with symptomatic and recurrent persistent AF? * Will first-line cryoablation for PVI, compared to AAD result in a superior improvement in health related Quality of Life (HRQoL), AF/AT burden, AF/AT progression and reversion, more reverse atrial remodeling, cognitive function, healthcare utilization with associated costs, better safety, at 12-24-36 months as compared with drug use? Participants will be randomized 1:1 to first-line PVI using the cryoballoon or to first-line antiarrhythmic drug therapy and during 3 years follow-up undergo regular;

* Continuous ECG monitoring for assessment of first AF recurrence and AF burden using an implantable cardiac monitor, * Regular echocardiographic exams for reverse atrial remodelling assessment, * HRQoL questionnaires * Assessment of cognitive function * Atrial fibrillation evaluation regarding structured characterisation and AF progression/regression * Assessment of Health care use and costs * Safety

Bevonási feltételek: Non-longstanding persistent symptomatic AF with at least 2 episodes within last 24 months, the latest episode within the previous 6 months and one documented on a 12 lead ECG or Holter monitor, that is classified as either; Classical persistent AF (continuously sustained beyond 7 days and <12 months in duration) as defined by ESC guidelines14 OR; Persistent AF which has progressed from paroxysmal AF (patients who have been cardioverted within 7 days of onset provided a history of spontaneous conversion to sinus rhythm is lacking during the past 24 months); Candidate for rhythm control therapy; AF ablation or AAD based on symptomatic AF.

Kizáró feltételek: Previous AF ablation or surgery; Myocardial infarction, revascularisation previous 6 months; Stroke or Transient Ischemic Attack (TIA) within previous 6 months; Conventional contraindications for AF ablation including AF due to reversible causes and contraindications for both class IC and class III antiarrhythmic drugs; Expected survival less than 3 years, alcohol or drug abuse; Severe heart failure (NYHA III-IV); Significant valvular disease requiring treatment or valve prothesis; Planned cardiac intervention within the next 12 months or cardiac surgery last 6 months; Reduced left ventricular ejection fraction (LVEF ≤40 % during sinus rhythm); Severe Chronic Obstructive Pulmonary Disease (COPD) stage III or chronic kidney disease (eGFR< 30 umol/l)); Regular daily use of AAD class I or III at adequate therapeutic dosages (pill-in-the-pocket permitted, beta-blockers permitted); Hypertrophic cardiomyopathy (septal or posterior wall thickness >1.5 cm); Severely enlarged LA with left atrial volume indexed to body surface area (LAVI, ml/m2) > 48; Tachycardiomyopathy; Dependent on VVI (ventricular single chamber inhibited) pacing; Participation in another trial or absence of consent.

ClinicalTrials.gov NCT05939076 · EU CTIS 2023-505962-28-00