The aim of this study is to investigate the efficacy and safety of minimally invasive surgery after five year follow up in a cohort of patients with symptomatic, drug refractory, paroxysmal or persistent AF. The patients will have an additional…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-Freedom of any recurrence of atrial fibrillation, atrial flutter or atrial
tachycardia, documented on ECG or 24-hour Holter within five years after
the procedure without the use of antiarrhythmic drugs.
-Sinus rhythm on electrocardiogram at follow up visit five years or more ofter
the procedure.
-Use of antiarrhythmic drugs at follow up visit.
Secondary outcome
-Functional status measured by the SF-36 Quality of Life questionnaire at 60
months follow up.
-The occurrence of any procedure related complications and the occurrence of
other clinical events during 60 months follow up.
-Major adverse cardiac events (MACE) during 60 months or more follow up.
Background summary
Atrial Fibrillation (AF) is the most common cardiac arrhythmia. Treatment of AF
is challenging, despite increasing pharmacological and technological treatment
options. Patients with symptomatic AF, who are refractory to antiarrhythmic
drugs (AAD), have an indication for invasive treatment, either with catheter
ablation or with surgical ablation. Catheter based interventions have a lower
single procedure success rate of 57% off AAD after a mean follow up of 14
months1, but are less invasive than minimally invasive surgery for AF. A
systematic literature overview by Krul et al. showed that the single procedure
success rate for minimally invasive surgery is 69% (95% CI, range 58%-78%)
without AAD and 79% (95% CI, range 71%-85%) at one year follow up with AAD2.
Long term follow up data on invasive treatment options for AF is limited.
Studies show that success rates after a single catheter ablation procedure
decrease significantly to 16.8%- 29% at five year follow up3 4. In previous
studies on minimally invasive surgery with a maximum follow up of 30 months,
the success rates does not seem to decrease further after one year follow up5.
However, these studies have high numbers of patients, who are lost to follow
up. Therefore, clinical data on long term outcome of minimally invasive
surgical ablation is sparse. This study is aimed to investigate the efficacy
and safety of minimally invasive surgery after five year follow up in a cohort
of patients with paroxysmal and persistent AF.
Study objective
The aim of this study is to investigate the efficacy and safety of minimally
invasive surgery after five year follow up in a cohort of patients with
symptomatic, drug refractory, paroxysmal or persistent AF. The patients will
have an additional follow up visit at the outpatient clinic of the department
of Cardiology more than five years after the surgical procedure .
Study design
This study is a retrospective, single center, cohort study.
Study burden and risks
This study poses no significant risk for the participants.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients who have undergone minimal invasive surgical ablation for paroxysmal or persistent atrial fibrillation between 2008 and 2010 in the Academic Medical Center.
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 | NL53839.018.15 |