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Marquis MVP download study – This clinical study, which evaluated the performance of
MVP mode pacing in the Marquis DR Model 7274 devices, provides support for MVP mode
in the Protecta XT DR Model D314DRG devices.
Marquis VR Single Chamber ICD study – This clinical study, which evaluated the
operation of the Wavelet Auto-Template Algorithm in the Model 7230 Marquis VR devices,
provides support for the Wavelet detection feature in Protecta XT DR Model D314DRG
devices.
Medtronic Impedance Diagnostics in Heart Failure Trial (MIDHeFT) – This clinical
study, which demonstrated the use of intrathoracic impedance as a surrogate measure of
fluid status in patients with heart failure, provides support for the OptiVol Fluid Status
Monitoring feature in Protecta XT DR Model D314DRG devices.
PR Logic with Wavelet performance – This retrospective evaluation was conducted to
demonstrate the safety and performance of the combined PR Logic and Wavelet SVT
discrimination features by assessing the impact to VT/VF detection sensitivity and
specificity of turning Wavelet on in dual chamber ICD and CRT-D devices. This evaluation
provides support for the PR Logic and Wavelet features in Protecta XT DR Model D314DRG
devices.
Protecta detection performance – This retrospective evaluation was performed using
human rhythms collected from various clinical trials and provides support that the addition
of multiple therapy discriminators in the Protecta products do not affect the overall detection
performance of the Protecta XT DR Model D314DRG devices.
Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT) – This
clinical study evaluated the efficacy of the intervention pacing therapies on symptomatic
AT/AF episodes in subjects where the lead was placed in the Bachmann’s Bundle region.
The results of the study failed to demonstrate effectiveness of the intervention pacing
therapies. Evaluation of the RESPECT study data indicated that the intervention pacing
features did not significantly reduce the rate of symptomatic AT/AF episodes and these
results did not confirm the findings from previous trials. The pre-specified subgroups were
tested for therapeutic effect, but none had results suggesting benefit. When intervention
pacing algorithms were programmed ON, atrial pacing percentage increased by 18.1%
(P<0.001) with a modest, yet statistically significant, increase in mean heart rate of 2.4 beats
per minute (P<0.001).
RV Lead Integrity Alert retrospective evaluation – This retrospective evaluation
assessed the ability of the RV Lead Integrity Alert feature to provide advance notice of a
Sprint Fidelis lead fracture. The evaluation provides support for the RV Lead Integrity Alert
feature in Protecta XT DR Model D314DRG devices.
RV Lead Noise Discrimination VF detection performance – This retrospective
evaluation was conducted using spontaneous rhythms and provides support that the RV
Medtronic
PROTECTA™ XT DR D314DRG
Clinician Manual
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