The aim of this study is to investigate the acute and long-term efficacy of the second generation CB after with a follow up range of 1-5 years follow up. In a cohort of patients with drug resistance persistent atrium fibrillation.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Freedom of recurrence of atrial fibrillation (>30sec documented on ECG, Holter
or CIED). Recurrence of AF will be categorized in paroxysmal (if less than
7days), persistent (if between 7days- 1 year) or longstanding persistent (if
less than 1year). The occurrence will be categorized in four groups, one or
less AF episode a year, 2-3 AF episodes a year, more than 3 AF episodes a year
or permanent AF.
Secondary outcome
- Use of anti arrhythmic drugs during the follow up period.
- Freedom of recurrence of any atrial arrhythmia (>30sec documented on ECG,
Holter or CIED).
- Quality of life (AFEQT questionnaire).
- Symptoms of palpitations after ablation
- Acute procedural success
- Early complications:
- Groin vascular complication,
- Transient phrenic nerve palsy,
- Pericardial effusion.
- Procedural stroke
- Late complications:
- Persistent phrenic nerve palsy,
- Venous thrombosis,
- 30 days mortality.
- Procedural characteristics; procedure time, fluoroscopic time, total ablation
time, total amount of applications.
- Cryo characteristics; pulmonary veins failed to isolate, average temperature
during application.
Background summary
Pulmonary veins isolation has become a cornerstone in treatment of atrial
fibrillation since several years. Multiple modalities can be used to achieve
isolation. With improvement of ablation techniques, the success rate at 1-year
increases to 50-75%. No studies have been published that describe the follow up
duration beyond 24 months.
Study objective
The aim of this study is to investigate the acute and long-term efficacy of the
second generation CB after with a follow up range of 1-5 years follow up. In a
cohort of patients with drug resistance persistent atrium fibrillation.
Study design
This is a prospective, single arm, observational cohort study.
Study burden and risks
This studie carries no extra risks for participants.
Oosterpark 9
Amsterdam 1091AC
NL
Oosterpark 9
Amsterdam 1091AC
NL
Listed location countries
Age
Inclusion criteria
(i) Index pulmonary veins isolation between 2012-2017 (ii) second generation cryo ballon used during pulmonary vein ablation (iii) persistent atrial fibrillation (>7 days, <1 year) as initial indication for ablation
Exclusion criteria
(i) Any left atrium ablation prior to index pulmonary veins isolation (ii) additional ablation lines, except cavotricuspid isthmus line (iii) unwilling/ uncapable to provide informed consent for long term follow up.
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 | NL63586.100.17 |