Assessment of Cardiac Resynchronization Therapy in Patients With Wide QRS and Non-specific Intraventricular Conduction Delay: a Randomized Trial
Megadott ok: funding recruitment issues
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A vizsgálat adatai
- Ki végzi
- University Hospital, Clermont-Ferrand
- Azonosító
- NCT02454439
- A regiszteradat frissítve
- 2026. november 12.
- Eredeti leírás
The aim of the NICD-CRT study is to assess whether CRT may be clinically beneficial in HF patients with NICD and reduced ejection fraction on 12-month HF status.A teljes eredeti leírásKevesebb
The aim of the NICD-CRT study is to assess whether CRT may be clinically beneficial in HF patients with NICD and reduced ejection fraction on 12-month HF status.
In effect, the effectiveness of cardiac resynchronization therapy in heart failure (HF) with reduced ejection fraction patients with non specific intraventricular conduction delay (NICD) has never been confirmed even if it is recommended.
At the moment, no dedicated study has already been performed to assess the benefit of CRT in patients with NICD. Results from CRT therapy are contradictory in this patient group and have only been obtained from subgroup analysis. Some of them don't show clinical benefit but others show a benefit in term of an end-diastolic and/or end-systolic left ventricular volume (decrease of the size and the volumes of left ventricule).
The AHA/ACCF guidelines, published in 2005 and updated in 2009, considered only QRS duration (≥120 ms) for the indication of CRT implantation, without any consideration for the type of conduction disorder (i.e. LBBB vs. non-LBBB), current updated 2012 ACCF/AHA/HRS guidelines, consider QRS morphology (i.e. LBBB) as the first step for CRT candidate selection in addition to QRS duration (>150 ms). Indications for resynchronization have been restricted since indication of CRT in non-LBBB patients (e.g. NICD) is only a class IIa (>150 ms, only in NYHA III and ambulatory IV; level of evidence A). The same modifications have been applied between 2011 and 2013 in the European guidelines. None is known about patients with NICD and QRS > 130 ms.
Bevonási feltételek: Patients over 18 years' old; NYHA class II to IV ambulatory; QRS duration > 130 ms; Patients with sinus rhythm; LVEF < 35%; QRS morphology: NICD according to the AHA/ACCF/HRS9 Recommendations (non-LBBB and non-RBBB):; Not broad notched or slurred R wave in leads I, aVL, V5 and V6; Presence of a Q wave in leads I, V5, V6; No rsr', rsR' or rSR' pattern in leads V1 or V2; Life expectancy expected to exceed one year with a good functional status; Optimal pharmacological therapy of heart failure according to clinician; Non inclusion criteria :; Inability to understand nor decline the study,; Impaired mobility,; Unable to fill out questionnaire independently,; Patients with permanent atrial fibrillation,; Pregnant women,; Dependant adult,; Patients minor,; Life expectancy < 1 year due to other causes than HF.