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NCT02695277Completed

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

Source: ClinicalTrials.gov · Last updated 15 Oct 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
146 (actual)
First submitted
14 Dec 2015
Start date
1 Nov 2015
Primary completion date
30 Nov 2022
Lead sponsor
AtriCure, Inc.
NCT number
NCT02695277

What you commit to

  • Study type: Interventional
  • Participants enrolled: 146
  • From 1 Nov 2015 to the primary completion date, 30 Nov 2022
  • 12 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient underwent previous ablation procedure or heart surgery
  • 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)
  • History of cerebrovascular disease, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment
  • Contraindication to anticoagulant therapy, or inability to comply with anticoagulant therapy
  • Patient is involved in another study involving an investigational drug or device

Other illness

  • AF is secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause
  • Patient needs other cardiac surgery procedures besides AF treatment (valve, coronary, others)
  • Active infection or sepsis
  • Other clinical conditions precluding inclusion (e.g., organ disease, disturbances of hemostasis)

Lab values

  • Left ventricular ejection fraction \< 30 %

Age

  • Patient has longstanding persistent AF \> 10 years

Other

  • Patient presenting with paroxysmal AF
  • Patient with persistent AF and a LA-diameter ≤ 4cm
  • Body mass index \> 35
  • LA Diameter \> 6 cm
  • Severe mitral regurgitation (\>II)
  • Patient unable to undergo TransEsophageal Echocardiogram (TEE)
  • Presence of LA thrombus by TEE, CT scan, MRI or angiography
  • Pregnancy, planned pregnancy or breastfeeding
  • Life expectancy is less than 12 months

Who the study is looking for

  • 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
  • Patient is refractory to or intolerant of at least one antiarrhythmic drug (class I or III)
  • Patient is mentally able and willing to give informed consent

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dr Tomáš Ostřížek
Coordinator of this site? Confirm its status
BrnoCzechiaUnknown status
Czech Budejovice Hospital, Inc.
Coordinator of this site? Confirm its status
České BudějoviceCzechiaUnknown status
Cardiovascular Center Bad Neustadt
Coordinator of this site? Confirm its status
Bad Neustadt an der SaaleGermanyUnknown status
Schüchtermann-Schiller'sche Kliniken Herzzentrum Osnabrück
Coordinator of this site? Confirm its status
Bad RothenfeldeGermanyUnknown status
Heart Center Leipzig
Coordinator of this site? Confirm its status
LeipzigGermanyUnknown status
Klinikum Ludwigsburg
Coordinator of this site? Confirm its status
LudwigsburgGermanyUnknown status
Peter Osypka Heart Center Munich
Coordinator of this site? Confirm its status
MunichGermanyUnknown status
Kliniken Sindelfingen
Coordinator of this site? Confirm its status
SindelfingenGermanyUnknown status
Sana Heart Center Stuttgart
Coordinator of this site? Confirm its status
StuttgartGermanyUnknown status
Northern General Hospital
Coordinator of this site? Confirm its status
SheffieldUnited KingdomUnknown status
St. Antonius Hospital
Coordinator of this site? Confirm its status
NieuwegeinNetherlandsUnknown status
Central Clinical Hospital of the Ministry of Interior
Coordinator of this site? Confirm its status
WarsawPolandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.