User Manual Part 2

D-1
CLINICAL STUDY - VENTAK AV II DR
APPENDIX D
CLINICAL STUDY POPULATIONS
Guidant ICDs have been demonstrated to be safe and effective in patient
populations including, but not limited to, those with:
• Prior myocardial infarction and an ejection fraction (EF) ≤ 30%, based on
the G uidant sponsored MADIT II clinical study. (Guidant devices were the
only device s studied in the MADIT II clinical tria l. The trial d e monstrated
these devices to be safe and effective in the MADIT II population.)
• Prior myocardial infarc tion, left ventricular ejection fraction of ≤ 35%, and
a documented episode of nonsustained VT, with an inducible ventricular
tachyarrhythmia, based on the Guidant sponsored MADIT clinical study.
(Guidant devices were the only devices studied in the MADIT clinical trial.
The trial demonstrated these devices to be safe and effective in the MADIT
population.)
CHRONIC IMPLANT STUD Y - VENTAK AV II DR
Since this pulse generator system has many of the same therapies, diagnostics,
and electrophysiology testing features as the VENTAK AV III DR system, the
VENTAK AV II DR implant study, which was used to support the VENTAK AV III
DR system, was used also to support this pulse generator system.
The purpose of the implant study was to confirm that the VENTAK AV II DR
could sense, detect, and deliver ventricular tachyarrhythmia therapy. In
addition, the adaptive-rate pacing function was evaluated by exercise testing.
Fifty-two patients were enrolled and implanted in 18 centers outside the U.S.
between June 27 and October 21, 1997. A total of 53 devices were used
throughout the duration of the study and consisted of VENTAK AV II DR,
models 1821 and 1826. The VENTAK AV II was approved for commercial
distribution in the U.S. on March 13, 1998.
This clinical data remains applicable to these pulse generator systems since
there are no significant differences between tachyarrhythmia therapy and
adaptive-rate p acing capabilities.
- DRAFT -