Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation [CEASE AF - Trial]

Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation [CEASE AF - Trial] - CEASE-AF

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42344

Enrollment

Registered

2015-12-01

Start date

2016-03-23

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

atrial fibrillation fibrillation

Interventions

hybrid ablation versus standard catheterablation. For the endoscopic epicardial surgery of patients in the hybrid arm CE marked&nbsp

AtriCure devices will be used for the ablation procedure. Endoscopic surgery will include a minimum lesion set including a PV isolation&nbsp

by the means of a box lesion (right and left epicardial isolation of the PVs,&nbsp

superior and inferior connecting lines) and exclusion of the left atrial&nbsp

appendage if considered safe by the surgeon under general anesthesia.&nbsp

Additional lesions may be performed, based on standard practice at the&nbsp

interventional sites. Catheter ablation will be performed using standard endocardial transvenous&nbsp

technique of PV isolation and possibly additional ablations on physician*s&nbsp

discretion / center's strategy which are in accordance with current guidelines. For details refer to section 7 of the Protocol.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with Persistent and Longstanding Persistent Atrial Fibrillation  Patient is refractory to or intolerant of at least one antiarrhythmic drug (class I or III)

Exclusion criteria

Exclusion criteria: 1. Patient has longstanding persistent AF > 10 years  2. Patient presenting with paroxysmal AF  3. Patient with persistent AF and a LA-diameter <= 4cm  4. AF is secondary to electrolyte imbalance, thyroid disease, or other reversible  or non-cardiovascular cause

Design outcomes

Secondary

Measure	Time frame
The Secondary Effectiveness Endpoint is freedom from documented AF/AFL/AT) >30 seconds through 24 and 36 months follow-up, in the absence of Class I or III AADs (with the exception of previously failed AADs at doses not exceeding those previously failed). The rhythm status used for evaluation of the Primary and Secondary Endpoint will be derived from regularly scheduled 48-hour Holter monitoring and any symptom driven monitoring performed.	—

Measure

Time frame

The Secondary Effectiveness Endpoint is freedom from documented AF/AFL/AT) >30 seconds through 24 and 36 months follow-up, in the absence of Class I or III AADs (with the exception of previously failed AADs at doses not exceeding those previously failed). The rhythm status used for evaluation of the Primary and Secondary Endpoint will be derived from regularly scheduled 48-hour Holter monitoring and any symptom driven monitoring performed.

—

Primary

Measure	Time frame
The Primary Effectiveness Endpoint is freedom from documented AF/AFL/AT episodes > 30 seconds through 12 months follow-up, in the absence of Class I or III AADs (with the exception of previously failed AADs at doses not exceeding those previously failed).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)