An interventional study of HIFU AF Ablation in Coronary Arteriosclerosis, Atrial Fibrillation and Coronary Artery Bypass Graft Surgery, sponsored by Abbott Medical Devices. Terminated at 10 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-04.
Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Treatment
Concomitant AF ablation with HIFU in patients with persistent or long standing persistent AF undergoing CABG will be superior in restoring SR, compared with patients with persistent or long standing persistent AF undergoing CABG treated with best medical treatment according to ACC/AHA/ESC 2006 guidelines and no AF ablation.
Primary Objective
Secondary Objectives
3,869 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.
This study's enrollment of 188 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
HIFU AF Ablation
Device: HIFU AF Ablation
Best medical treatment
Concomitant left atrial ablation using High Intensity Focused Ultrasound (HIFU)
Also known as: • Epicor™ UltraCinch™ LP Ablation Device, • Epicor™ UltraWand™ LP Tissue Ablation Wand, • Epicor™ LP Positioning and Sizing (LP PAS™) System, • Epicor™ LP Oblique Introducer
Freedom from Atrial Arrhythmias (AF, Atrial Flutter, Atrial Tachycardia) at 12 months
Time frame: 12 months
Freedom from AF and other atrial arrhythmias at 3, 6, 9 and 18 months post ablation procedure (determined by 24 hour Holter monitor)
Time frame: 18 months
Freedom from AF and other atrial arrhythmias at 24 months post ablation procedure (determined by 72 hour Holter monitor)
Time frame: 24 months
AF burden (determined by 24 and 72 hour Holter monitor).
Time frame: 24 months
Morbidity performing concurrent ablation in patients undergoing CABG assessed using length of ICU and hospital stay
Time frame: 24 months
Incidence of stroke, TIA, PV stenosis, bleeding, thromboembolic complications, subsequent pace maker implantation, and death
Time frame: 24 months
LV function and dimensions and LA size/transport capability
Time frame: 24 months
Incidence of conduction block post ablation both intraoperatively across the pulmonary venous and mitral lines
Time frame: At intervention
Effect of autonomic ganglia stimulation pre and post ablation intra-operatively
Time frame: Discharge
Quality of life measurements (SF-36)
Time frame: 24 months
This study is terminated, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Abbott Medical Devices