Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— CEASE-AF  

Official title:

Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02695277
• Other study ID #: CP2015-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 2024

Study information

• Verified date: November 2022
• Source: AtriCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, randomized (2:1) multicenter trial to investigate the optimal treatment of Persistent and Longstanding Persistent AF referred for Radiofrequency (RF) ablation.The study objective is to compare the efficacy and safety of two interventional approaches, in preventing the recurrence of AF in symptomatic, drug refractory patients with persistent or longstanding persistent atrial fibrillation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 146
• Est. completion date: December 2024
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patient has a history of symptomatic Persistent AF and a left atrium (LA) > 4cm or Long Standing Persistent AF as defined by the HRS/EHRA/ECAS expert consensus statement

2. Patient is refractory to or intolerant of at least one antiarrhythmic drug (class I or III)

3. Patient is mentally able and willing to give informed consent

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

5. Patient underwent previous ablation procedure or heart surgery

6. Patient needs other cardiac surgery procedures besides AF treatment (valve, coronary, others)

7. Contraindication for either catheter ablation or epicardial surgery (including, but not limited to: previous thoracic radiation, previous perimyocarditis, Previous cardiac tamponade, Pleural adhesions, Prior thoracotomy)

8. Body mass index > 35

9. LA Diameter > 6 cm

10. Left ventricular ejection fraction < 30 %

11. Severe mitral regurgitation (>II)

12. Patient unable to undergo TransEsophageal Echocardiogram (TEE)

13. Presence of LA thrombus by TEE, CT scan, MRI or angiography

14. History of cerebrovascular disease, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment

15. Active infection or sepsis

16. Other clinical conditions precluding inclusion (e.g., organ disease, disturbances of hemostasis)

17. Contraindication to anticoagulant therapy, or inability to comply with anticoagulant therapy

18. Pregnancy, planned pregnancy or breastfeeding

19. Life expectancy is less than 12 months

20. Patient is involved in another study involving an investigational drug or device

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent and Longstanding Persistent Atrial Fibrillation

Intervention

Device:
• AtriCure Bipolar System

• Standard Endocardial Ablation with Catheter

• AtriClip® PRO LAA Exclusion System

• Endocardial Ablation with Catheter

• Repeated Endocardial ablation(s)

Locations

Country	Name	City	State
Czechia	Dr Tomáš Ostrížek	Brno
Czechia	Czech Budejovice Hospital, Inc.	Budweis
Germany	Cardiovascular Center Bad Neustadt	Bad Neustadt An Der Saale
Germany	Schüchtermann-Schiller'sche Kliniken Herzzentrum Osnabrück	Bad Rothenfelde
Germany	Heart Center Leipzig	Leipzig
Germany	Klinikum Ludwigsburg	Ludwigsburg
Germany	Peter Osypka Heart Center Munich	Munich
Germany	Kliniken Sindelfingen	Sindelfingen
Germany	Sana Heart Center Stuttgart	Stuttgart
Netherlands	St. Antonius Hospital	Nieuwegein
Poland	Central Clinical Hospital of the Ministry of Interior	Warsaw
United Kingdom	Northern General Hospital	Sheffield

Sponsors (2)

Lead Sponsor	Collaborator
AtriCure, Inc.	Cardialysis BV

Countries where clinical trial is conducted

Czechia,  Germany,  Netherlands,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Composite major complications		Up to 180 days (6-months) post index procedure
Primary	Number of subjects free from documented Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) episodes > 30 seconds in duration through 12 months follow-up, in the absence of Class I or III Antiarrhythmic Drugs (AADs).		Through 12-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure)
Secondary	Number of subjects free from documented AF, AFL or AT episodes > 30 seconds in duration through 24 and 36 months follow-up, in the absence of Class I or III AADs.		Through 24- and 36-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure)