User's Manual

18 – US-ENGLISH
6. CLINICAL STUDIES
Clinical data presented in this section are from the MSP clinical
study. PARADYM RF SonR 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 SonR 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 VO
2
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.