CONTAK RENEWAL® TR Cardiac Resynchronization Therapy Pacemaker (CRT-P)

Key Features

Independent Channels
Independently programmable right ventricular (RV) and left ventricular (LV) pacing and sensing

• RV sensing is used to establish RV-based timing and RV pacing inhibition
• LV sensing is only used for LV pacing inhibition

Ventricular Rate Regulation (VRR)
Meant to reduce irregular ventricular intervals during conducted atrial fibrillation

• Maximizes CRT delivery when programmed to the Maximum setting
• Only active during ATR mode switch in tracking modes
• Available continuously in VVI(R) and DDI(R) modes
• Programmable: Off, Minimum, Medium, Maximum

Atrial fibrillation (AF) in heart failure (HF) patients

• The prevalence of AF increases as the severity of HF increases.¹
• The incidence of AF in HF patients ranges from 10% to 50%. The highest incidence is in those with severe HF.²
• Patients with AF and severe HF experience a reduction in stroke volume, cardiac output and peak oxygen consumption.¹
• These patients have a reduction of approximately 20% in cardiac output.¹

VRR Setting	% Pacing	Rate (ppm)	Standard Deviation (ms)
Off	0	91	138
Min	40	93	93
Med	71	94	71
Max	80	96	52

* Therapy results may vary by patient.

IS-1 or LV-1 Left Ventricular Pace/Sense Lead Port

• Model H120 offers an IS-1 left ventricular pace/sense lead port
• Model H125 offers an LV-1 left ventricular pace/sense lead port

Left Ventricular Protection Period (LVPP)
Meant to prevent pacing during the left ventricular vulnerable period (T-wave)

• LVPP is the period after a left ventricular event, either paced or sensed, when LV pacing is inhibited
• Programmable: 300-500 ms

Tracking Preference
Meant to maintain atrial-tracked ventricular pacing in DDD(R) and VDD(R) modes

• Temporarily reduces PVARP to reestablish atrial-tracked ventricular pacing inappropriately lost due to atrial events occurring in PVARP
• Programmable: On, Off

Patient-centric Diagnostics

HRV Monitor Footprint
Measures changes in intrinsic heart rate and plots the distribution of variability versus heart rate over a 24-hour period

• Displays current footprint and one previously stored footprint to allow for comparison
• Heart rate is plotted on the X axis, variability is plotted on the Y axis, and frequency is plotted using color
• Shows a percentage for the total plot area covered by the footprint
• Vertical line indicates mean heart rate
• Increases in plot area indicate increases in heart rate variability (HRV) and/or heart rate range

HRV Monitor Trending
Plots heart rate (mean, minimum and maximum), HRV Monitor Footprint percentages, and SDANN

Activity Log
Plots the percent of day active for every day of the last week and average weekly data from every week of the last year

• Percent of day active is the percent of day the accelerometer-indicated motion is above a fixed minimal threshold

Mechanical Specifications

Model	Type	Size (cm) (H x W x D)	Mass (g)	Volume (cc)	Atrial and Right Ventricular Pace/Sense Lead Ports	Left Ventricular Pace/Sense Lead Port
H120	DR	5.4 x 4.5 x .85	26	14	IS-1	IS-1
H125	DR	5.4 x 4.5 x .85	26	14	IS-1	LV-1

References

1. Maisel WH, Stevenson LW. Atrial fibrillation in heart failure: epidemiology, pathophysiology, and rationale for therapy. Am J Cardiol. 2003;91(suppl):2D-8D.
2. The AF-CHF Trial Investigators. Rationale and design of a study assessing treatment strategies of atrial fibrillation in patients with heart failure: the Atrial Fibrillation and Congestive Heart Failure (AF-CHF) trial. Am Heart J. 2002;144:597-607.