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Triple‐Site Versus Standard Cardiac Resynchronization Therapy Study (TRUST CRT): Clinical Rationale, Design, and Implementation
Author(s) -
LENARCZYK RADOSŁAW,
KOWALSKI OSKAR,
SREDNIAWA BEATA,
PRUSZKOWSKASKRZEP PATRYCJA,
PLUTA SŁAWOMIR,
SOKAL ADAM,
KUKULSKI TOMASZ,
STABRYŁADESKA JOANNA,
WOŹNIAK ALEKSANDRA,
KOWALCZYK JACEK,
ZIELIŃSKA TERESA,
MAZUREK MICHAŁ,
STREB WITOLD,
ZEMBALA MARIAN,
KALARUS ZBIGNIEW
Publication year - 2009
Publication title -
journal of cardiovascular electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.193
H-Index - 138
eISSN - 1540-8167
pISSN - 1045-3873
DOI - 10.1111/j.1540-8167.2008.01394.x
Subject(s) - medicine , cardiac resynchronization therapy , ejection fraction , cardiology , heart failure , clinical endpoint , qrs complex , sinus rhythm , randomized controlled trial , single center , atrial fibrillation
Background: Cardiac resynchronization therapy (CRT) reduces morbidity and mortality in patients with heart failure (HF), lowered LV ejection fraction, and wide QRS. However, many patients (≤40%) do not respond to this form of pacing. TRUST CRT is a prospective, single‐center, randomized, single‐blind, parallel, and controlled study that has been designed to treat patients with moderate to severe HF (NYHA III‐IV), QRS ≥120 ms, sinus rhythm, LV dysfunction (EF ≤ 35%), and signs of mechanical dyssynchrony. Objective: The primary objective will evaluate the 6‐month's combined endpoint of alive status, freedom from hospitalization for HF or heart transplantation, relative ≥10% increase in LV ejection fraction, ≥10% in peak oxygen consumption, and ≥10% in 6‐minute walking distance. Methods: Patients with HF receiving optimal pharmacotherapy, with LV dysfunction, mechanical dyssynchrony, wide QRS and sinus rhythm will be randomized in a 1: 1 fashion to standard or triple‐site CRT‐D. Patients will be followed for 1 week, 1, 3, and 6 months during a blind phase, then every 6 months until study completion. One hundred patients will be enrolled by the study center. Conclusions: TRUST CRT is a randomized, clinical trial in CRT candidates to evaluate the effectiveness of triple‐site pacing versus standard resynchronization in patients with HF.