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Long-term follow up after second generation cryo balloon ablation in patients with persistent atrial fibrillation: A single centre cohort with 5 years follow up.

Long-term follow up after second generation cryo balloon ablation in patients with persistent atrial fibrillation: A single centre cohort with 5 years follow up. - CRYOpers

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46403
Enrollment
150
Registered
2018-03-23
Start date
2018-09-03
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

recurrence of atrial fibrillation

Interventions

None listed

Sponsors

Onze Lieve Vrouwe Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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,

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
- 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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)