Thoracoscopic surgical versus catheter ablation approaches for primary treatment of persistent atrial fibrillation

Thoracoscopic surgical versus catheter ablation approaches for primary treatment of persistent atrial fibrillation - APPROACH AF

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48892

Enrollment

120

Registered

2019-03-06

Start date

2019-09-25

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

Atrial fibrillation supraventricular arrythmia

Interventions

Pumonary vein isolation by means of catheter ablation or thoracoscopic surgical ablation

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age is between 18 and 80 years. - Persistent AF as defined following the ESC 2016 Guidelines, evidenced by 1) ongoing AF on the ECG or 2) documentation of AF necessitating cardioversion. - AF documented by ECG or Holter

Exclusion criteria

Exclusion criteria: - Prior intervention (catheter ablation or minimally-invasive thoracoscopic ablation) for AF. - AF is secondary to electrolyte imbalance, thyroid disease or other reversible or non-cardiovascular causes. - Paroxysmal AF - Long standing Persistent AF, defined as AF continuously present for longer than 1 year. - Body mass index >35kg/m2

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is freedom of AF, defined as absence of any atrial tachyarrhythmia without the use of antiarrhythmic drugs during 12 months after a single procedure, at the moment that 72 patients have had a recurrence of atrial tachyarrhythmia. Freedom of atrial tachyarrhythmia is defined as the absence of documentation of episodes of atrial tachyarrhythmia lasting more than 30 seconds on Holter recordings during follow-up and/or on ECGs recorded outside the scope of the study. A 3-month blanking period during which recurrent atrial tachycardia*s are not considered a failure of the procedure, will be instituted conforming to current guidelines and consensus.	—

Measure

Time frame

The primary endpoint of the study is freedom of AF, defined as absence of any atrial tachyarrhythmia without the use of antiarrhythmic drugs during 12 months after a single procedure, at the moment that 72 patients have had a recurrence of atrial tachyarrhythmia. Freedom of atrial tachyarrhythmia is defined as the absence of documentation of episodes of atrial tachyarrhythmia lasting more than 30 seconds on Holter recordings during follow-up and/or on ECGs recorded outside the scope of the study. A 3-month blanking period during which recurrent atrial tachycardia*s are not considered a failure of the procedure, will be instituted conforming to current guidelines and consensus.

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Secondary

Measure	Time frame
The secondary endpoints include: - Freedom of arrhythmia after 12 months without AAD after a single procedure - Freedom of arrhythmia after 12 months with AAD after a single procedure - Freedom of arrhythmia after 12 months without AAD after both procedures - Freedom of arrhythmia after 5 years - Cost-effectiveness of both procedures in isolation, and the combination of both procedures - Quality of life	—

Measure

Time frame

The secondary endpoints include: - Freedom of arrhythmia after 12 months without AAD after a single procedure - Freedom of arrhythmia after 12 months with AAD after a single procedure - Freedom of arrhythmia after 12 months without AAD after both procedures - Freedom of arrhythmia after 5 years - Cost-effectiveness of both procedures in isolation, and the combination of both procedures - Quality of life

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)