Clinical trial NCT02695277: Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation
Official title: Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Persistent and Longstanding Persistent Atrial Fibrillation
Keywords: Atrial Fibrillation
Persistent and Longstanding Persistent AF
Hybrid Procedure
Catheter Ablation
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Cardialysis BV
First posted: 2016-03-01
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: Through 12-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure)
Secondary outcomes:
measure: 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.
timeFrame: Through 24- and 36-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure)
Other outcomes:
measure: Composite major complications
timeFrame: Up to 180 days (6-months) post index procedure
Locations:
city: Brno
country: Czechia
facility: Dr Tomáš Ostřížek
city: Budweis
country: Czechia
facility: Czech Budejovice Hospital, Inc.
city: Bad Neustadt An Der Saale
country: Germany
facility: Cardiovascular Center Bad Neustadt
city: Bad Rothenfelde
country: Germany
facility: Schüchtermann-Schiller'sche Kliniken Herzzentrum Osnabrück
city: Leipzig
country: Germany
facility: Heart Center Leipzig
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
city: Munich
country: Germany
facility: Peter Osypka Heart Center Munich
city: Sindelfingen
country: Germany
facility: Kliniken Sindelfingen
city: Stuttgart
country: Germany
facility: Sana Heart Center Stuttgart
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Warsaw
country: Poland
facility: Central Clinical Hospital of the Ministry of Interior
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
Study officials:
References: