Effect of biventricular upgrade on left ventricular reverse remodeling and clinical outcomes in patient in left ventricular dysfunction and intermittent or permanent apical/septal right ventricular pacing (Budapest CRT upgrade study)
The aim of this study is to investigate the effect of upgrade to a CRT-D device on clinical and echocardiographic response at 12-month in patients with left ventricular dysfunction (LVEF ≤35%), symptomatic heart failure (NYHA II, III, IV-a), and intermittent or permanent right ventricular pacing with paced QRS complex ≥ 150 ms compared to continued therapy with a single or dual chamber pacemaker (PM) or ICD. Prospective, post-market, international multicenter randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
Biventricular upgrade. Subjects meeting the inclusion criteria (and if exclusion criteria are not present) patients will be randomized to CRT-D upgrade or ICD only (either continued ICD therapy in patients currently implanted with a defibrillator or implantation of a defibrillator in eligible patients who are currently implanted with pacemaker-only).
Hannover Medical School
Hanover, Germany
Herzzentrum Leipzig GmbH
Leipzig, Germany
A composite clinical and echocardiographic end point comprising the first occurrence of a non-fatal heart failure event, all-cause mortality, or < 15% reduction in echocardiography determined LVESV from baseline to 12-month.
Time frame: 12 months
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Second Department of Internal Medicine and Cardiology Center, Faculty of Medicine, University of Szeged
Szeged, Csongrád megye, Hungary
Institute of Cardiology University of Debrecen
Debrecen, Hajdú-Bihar, Hungary
Hungarian Institute of Cardiology
Budapest, Hungary
Semmelweis University Heart and Vascular Center
Budapest, Hungary
Depratment of Cardiology, Military Hospital, Hungarian Army Medical Center
Budapest, Hungary
University of Pécs Medical School, Heart Institute
Pécs, Hungary
Barzilai Medical Center
Ashkelon, Israel
Kaplan Medical Center
Rehovot, Israel
...and 7 more locations