User's Manual

6. CLINICAL STUDIES
Clinical data presented in this section are from the MSP clinical study. PLATINIUM 4LV SonR
CRT-D 1844 is similar in design and function to the ALTO 2 MSP and OVATIO CRT-D devices.
The data provided are applicable to PLATINIUM 4LV SonR CRT-D 1844.
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.
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
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.
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 im-
provement in com-
posite endpoint for
control group
Mean percent im-
provement in com-
posite endpoint for
CRT-D group
Percent
greater im-
provement
for CRT-D
group
p-
value
132 15.5 % 24.9 % 9.4 % 0.046
Six-month system complication-free rate
Number of patients
contributing to
analysis
Kaplan-Meier six-month
complication-free esti-
mate
One-sided lower 95% confidence
bound for six-month complication-free
estimate
190 89.5 % 84.1 %
6.1.
6.1.1.
6.1.2.
6.1.3.
6. CLINICAL STUDIES
18 SORIN – PLATINIUM 4LV SonR CRT-D 1844 – U906A