To evaluate the long-term (up to 5-years after procedure) efficacy and safety of CA against SA in preventing the recurrence of LA arrhythmias in patients with a history of paroxysmal and/or persistent AF
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Freedom from any left atrial arrhythmia with or without the use of
anti-arrhythmic drugs
• Freedom from additional catheter ablation or rhythm surgery
Secondary outcome
• Freedom from MACE; Cardiovascular death, Myocardial infarction, Recurrent
ischemia requiring PCI or surgery
• Freedom from ischemic stroke
• Freedom from transient ischemic attack
• Freedom from cerebral bleeding
• Freedom from major bleeding needing transfusion
• Overall survival
• Freedom from pacemaker implantation
• Freedom from any LA arrhythmia with or without the use of OAC
• QOL
Background summary
The FAST-trial is a randomized controlled trial comparing catheter ablation
(CA) and surgical ablation (SA) for the treatment of atrial fibrillation (AF)
in patients with drug-refractory paroxysmal or persistent AF, and/or enlarged
atria, and/or failed previous ablation. SA was found to be superior to CA in
achieving freedom from left atrial (LA) arrhythmia after a 12-month follow-up,
albeit at the cost of a higher adverse event rate. The aim of this follow-up
study is to ascertain whether the difference in effect between treatment with
CA and SA further increases and whether the adverse event rate will be stable
over time.
Study objective
To evaluate the long-term (up to 5-years after procedure) efficacy and safety
of CA against SA in preventing the recurrence of LA arrhythmias in patients
with a history of paroxysmal and/or persistent AF
Study design
This is a multi-centre, prospective cohort study
Study burden and risks
This study involves participants having 7-day holter monitoring and one
hospital follow-up visit which will be combined. The visit will be performed at
the outpatient clinic of the participating centers. This registry is therefore
associated with only minimal burden and no risk for the patient. The patient*s
own cardiologist will be informed about the observations made by the holter
monitoring. Any new observations could obviously result in any change of
treatment. Generally, information from this study will benefit patients with
symptomatic drug-refractory paroxysmal or persistent AF and/or enlarged atria
and/or failed previous ablation, by allowing doctors to learn more about the
best way to treat these patients and improve patient quality of life.
Koekoekslaan 1
Nieuwegein 3435 cm
NL
Koekoekslaan 1
Nieuwegein 3435 cm
NL
Listed location countries
Age
Inclusion criteria
It includes the original included population of 124 patients that participated in the FAST trial.
Exclusion criteria
None
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 | NL55162.100.15 |