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.
- Diseases
- Atrial fibrillation
- 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
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr Tomáš Ostřížek Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| Czech Budejovice Hospital, Inc. Coordinator of this site? Confirm its status | České Budějovice | Czechia | Unknown status |
| Cardiovascular Center Bad Neustadt Coordinator of this site? Confirm its status | Bad Neustadt an der Saale | Germany | Unknown status |
| Schüchtermann-Schiller'sche Kliniken Herzzentrum Osnabrück Coordinator of this site? Confirm its status | Bad Rothenfelde | Germany | Unknown status |
| Heart Center Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Klinikum Ludwigsburg Coordinator of this site? Confirm its status | Ludwigsburg | Germany | Unknown status |
| Peter Osypka Heart Center Munich Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| Kliniken Sindelfingen Coordinator of this site? Confirm its status | Sindelfingen | Germany | Unknown status |
| Sana Heart Center Stuttgart Coordinator of this site? Confirm its status | Stuttgart | Germany | Unknown status |
| Northern General Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| St. Antonius Hospital Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Unknown status |
| Central Clinical Hospital of the Ministry of Interior Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.