User's Manual

6. CLINICAL STUDIES
6. CLINICAL STUDIES
Clinical data presented in this section are from the MSP clinical study. PLATINIUM CRT-D is
similar in design and function to the ALTO 2 MSP and OVATIO CRT-D devices. The data
provided are applicable to PLATINIUM 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’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.
6.1.1. 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.
6.1.2. 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
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.
6.1.3. Results
Improvement in composite endpoint
Patients were included in the analysis if complete (peak VO
2
and quality of life) baseline and
six-month data were available.
Number of
patients
contributing to
analysis
Mean percent
improvement in
composite
endpoint for
control group
Mean percent
improvement in
composite
endpoint for
CRT-D group
Percent greater
improvement for
CRT-D group
p-value
132 15.5 % 24.9 % 9.4 % 0.046
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SORIN – PLATINIUM CRT-D – U459A