to quantify atrial electropathology of the endocardium in adult patients with CHD and to correlate clinical characteristics, atrial volume, electropathology, atrial ectopy and features of pre- and post-procedural atrial fibrillation.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Cardiac and vascular disorders congenital
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quantification of electrophysiological parameters obtained from endocardial
mapping that determine the degree of electropathology: conduction block,
conduction delay, conduction velocity, signal morphology (voltage,
fractionation). These parameters will be correlated with electropathology,
atrial ectopy, atrial volume, clinical characteristics and features of pre- and
post-procedural atrial fibrillation.
Secondary outcome
N.a.
Background summary
Patients with congenital heart disease experience atrial fibrillation more
often and at a younger age than patients without congenital heart disease. In
addition, treatment of atrial fibrillation is more difficult in patients with
congenital heart disease.
Correction of the cardiac defect has decreased the incidence of atrial
fibrillation in this population, however it does not prevent atrial
fibrillation. Patients with congenital heart disease still develop more
frequently atrial fibrillation than patients without congenital heart disease.
Pre-existent disorders in the electrical conduction, caused by volume overload
due to the cardiac defect, are thought to play a role in the development of
this arrhythmia.
Study objective
to quantify atrial electropathology of the endocardium in adult patients with
CHD and to correlate clinical characteristics, atrial volume, electropathology,
atrial ectopy and features of pre- and post-procedural atrial fibrillation.
Study design
The ATLANTIS study is designed as an interventional multicenter study
Intervention
Endocardial mapping during sinus rhythm and programmed electrical stimulation
before and after endovascular closure of the cardiac defect.
Study burden and risks
For participants in this study there are no direct benefits. Neither the
patient, nor the investigator are in any way compensated for their
participation with regards to this study. The risks associated with
participation are known to be negligible, since endovascular mapping and
programmed electrical stimulation are performed routinely in standard
electrophysiological studies for the treatment of arrhythmia. For placement of
the catheters an additional venous access needs to be made in the groin. The
risks of such electrophysiological procedures are minimal. Programmed
electrical stimulation could induce atrial fibrillation. Theoretically atrial
fibrillation could lead to hemodynamic instability, often seen in patients with
severe heart failure. These patients are excluded from participating in this
study. Patient's vitals will be monitored closely throughout the procedure.
Consequently, if atrial fibrillation is induced, patient's heart rhythm will
immediately be converted to sinus rhythm with cardioversion. Potentially the
closure device could be dislocated during the electrophysiological study.
However, large defects at high risk for this complications will be excluded.
Measurements will be terminated immediately if such a scenario occurs. The
additional procedural time, and thus the general anaesthesia time, will be
lengthened by approximately 15-20 minutes. The additional anaesthesia time does
not increase the risk.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
>=18 years;
Scheduled for elective endovascular closure of atrial septal defect or patent
foramen ovale
Exclusion criteria
Paced atrial rhythms
Pacemaker/ internal cardiac defibrillator (ICD)
Hemodynamic instability
Presence of assist devices
Use of inotropic agents
Emergency endovascular cardiac procedures
Left ventricle ejection fraction < 30%
Severe kidney or liver failure
Receiving local anaesthesia
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL78227.078.21 |