Design and Rationale of the PRAGUE-12 Trial: A Large, Prospective, Randomized, Multicenter Trial That Compares Cardiac Surgery with Left Atrial Surgical Ablation With Cardiac Surgery Without Ablation in Patients With Coronary and/or Valvular Heart Disease
Identifikátory výsledku
Kód výsledku v IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11120%2F13%3A43906949" target="_blank" >RIV/00216208:11120/13:43906949 - isvavai.cz</a>
Výsledek na webu
<a href="http://dx.doi.org/10.1002/clc.22085" target="_blank" >http://dx.doi.org/10.1002/clc.22085</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1002/clc.22085" target="_blank" >10.1002/clc.22085</a>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
Design and Rationale of the PRAGUE-12 Trial: A Large, Prospective, Randomized, Multicenter Trial That Compares Cardiac Surgery with Left Atrial Surgical Ablation With Cardiac Surgery Without Ablation in Patients With Coronary and/or Valvular Heart Disease
Popis výsledku v původním jazyce
Surgical ablation procedure can restore sinus rhythm (SR) in patients with atrial fibrillation (AF) undergoing cardiac surgery. However, it is not known whether it has any impact on clinical outcomes. There is a need for a randomized trial with long-termfollow-up to study the outcome of surgical ablation in patients with coronary and/or valve disease and AF. Patients are prospectively enrolled and randomized either to group A (cardiac surgery with left atrial ablation) or group B (cardiac surgery alone). The primary efficacy outcome is the SR presence (without any AF episode) during a 24-hour electrocardiogram after 1 year. The primary safety outcome is the combined end point of death, myocardial infarction, stroke, and renal failure at 30 days. Long-term outcomes are a composite of total mortality, stroke, bleeding, and heart failure at 1 and 5 years. We finished the enrollment with a total of 224 patients from 3 centers in 2 countries in December 2011. Currently, the incomplete 1-ye
Název v anglickém jazyce
Design and Rationale of the PRAGUE-12 Trial: A Large, Prospective, Randomized, Multicenter Trial That Compares Cardiac Surgery with Left Atrial Surgical Ablation With Cardiac Surgery Without Ablation in Patients With Coronary and/or Valvular Heart Disease
Popis výsledku anglicky
Surgical ablation procedure can restore sinus rhythm (SR) in patients with atrial fibrillation (AF) undergoing cardiac surgery. However, it is not known whether it has any impact on clinical outcomes. There is a need for a randomized trial with long-termfollow-up to study the outcome of surgical ablation in patients with coronary and/or valve disease and AF. Patients are prospectively enrolled and randomized either to group A (cardiac surgery with left atrial ablation) or group B (cardiac surgery alone). The primary efficacy outcome is the SR presence (without any AF episode) during a 24-hour electrocardiogram after 1 year. The primary safety outcome is the combined end point of death, myocardial infarction, stroke, and renal failure at 30 days. Long-term outcomes are a composite of total mortality, stroke, bleeding, and heart failure at 1 and 5 years. We finished the enrollment with a total of 224 patients from 3 centers in 2 countries in December 2011. Currently, the incomplete 1-ye
Klasifikace
Druh
J<sub>x</sub> - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)
CEP obor
FA - Kardiovaskulární nemoci včetně kardiochirurgie
OECD FORD obor
—
Návaznosti výsledku
Projekt
—
Návaznosti
Z - Vyzkumny zamer (s odkazem do CEZ)<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Ostatní
Rok uplatnění
2013
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
Clinical Cardiology
ISSN
0160-9289
e-ISSN
—
Svazek periodika
36
Číslo periodika v rámci svazku
1
Stát vydavatele periodika
US - Spojené státy americké
Počet stran výsledku
5
Strana od-do
1-5
Kód UT WoS článku
000313712800001
EID výsledku v databázi Scopus
—