Lone Atrial Fibrillation Clinical Trial
Official title:
Concomitant Focal Epicardial Cryoablation During Mei Mini Maze Procedure in Treatment of Lone Atrial Fibrillation: A Randomized Controlled Trial
Atrial fibrillation (AF) increases risks of stroke, heart failure and sudden death. Single
catheter ablation only has a low success rate due to inadequate transmurality and continuity
of the lesion lines. Unilateral thoracoscopic epicardial ablation by radiofrequency energy
from left side (Mei Mini Maze procedure, 3M procedure) was applied in our institution in the
last 10 years, and gained reasonable results. A more attractive hybrid strategy of epicardial
and endocardial ablation was tested to improve the treatment of persistent AF in the
investigator's hospital (NCT02968056). Preliminary data from this trial found that
insufficient ablation around right upper pulmonary vein area was the key point leading to
failure or recurrence. In order to overcome this weakness of the current Mei Mini Maze
procedure, concomitant focal epicardial cryoablation performed during the operation may
reinforce the lesion lines. The hypothesis of the present study is that additional epicardial
cryoablation will improve the success rate compared to Mei Mini Maze procedure alone in the
treatment of AF.
This study is a prospective randomized controlled trial within a single institution. Lone AF
patients admitted to the cardiovascular surgery department of Shanghai Xinhua Hospital will
be screened for enrollment of this study. The study will recruit 150 patients in total. The
patients will be randomized allocated into Mei Mini Maze procedure group (3M group) and
Concomitant epicardial cryoablation group (3M + Cryoablation group). The 3M group patients
only have surgical ablation surgery from left thoracoscope as previously reported, while the
3M + Cryoablation group patients will have additional focal epicardial cryoablation around
right upper pulmonary vein area after the Mei Mini Maze procedure is done. The ratio of 3M to
3M + cryoablation group is 1:1, so that each group contains 75 patients. The perioperative
data is collected, and the patients will be followed for 6 months. The primary outcome is the
maintenance of sinus rhythm at 6 months post operation. The secondary outcomes include off
antiarrhythmic drug rate, perioperative complications, major cardiovascular events, stroke,
left ventricular systolic function, medical expense, serum brain natriuretic peptide level
and quality of life. The aim of this study is to evaluate the efficacy and safety of this
novel combined procedure of epicardial radiofrequency and cryoablation.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04776759 -
Atrial Fibrillation in Young Patients: a Prospective Multicentre Registry
|