User's Manual

20 – US-ENGLISH
6. CLINICAL STUDIES
Clinical data presented in this section are from the MSP clinical study.
PARADYM RF CRT-D is similar in design and function to the ALTO 2
MSP and OVATIO CRT-D devices. The data provided are applicable to
PARADYM RF CRT-D.
6.1. MSP CLINICAL STUDY
OVATIO CRT-D and earlier models were evaluated clinically in an
international, multi-center, randomized clinical trial of Sorin CRM’s
cardiac resynchronization therapy (CRT-D) system. Investigators
attempted to implant study devices in 190 patients.
A total of 182 patients received study devices and had an exposure of
over 165 device years. Of those patients, 19 received OVATIO CRT-D,
160 received ALTO 2 MSP, and 3 received ALTO MSP.
Objectives: The primary objectives of the study were to demonstrate:
─ Greater improvement in a composite endpoint (percent improvement in
peak VO2 percent improvement in quality of life) for CRT-D patients
than for control patients.
─ System complication-free rate ≥ 67 % at six months.
Methods: Patients were New York Heart Association class III or IV and
had one or more indications for an implantable cardioverter defibrillator
(ICD). Patients performed cardiopulmonary exercise testing at baseline
and six-months after randomization. Patients were implanted with a Sorin
CRM ICD with CRT-D, a Situs UW28D left ventricular lead, and
commercially available right atrial and ventricular leads. Routine follow-
ups were at pre-discharge, randomization (3-14 days post-implant), one
month, three months, and six months post randomization.