Abbott HF CRT-D Cardiac Resynchronization Therapy Devices Instructions

: August 12, 2024
: Abbott

Table of Contents

Abbott HF CRT-D Cardiac Resynchronization Therapy Devices
Product Highlights
Ordering Information
Product Specifications
Product Specifications
MRI SCAN PARAMETERS†
CDHFA500T Rx Only
FAQs
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Abbott HF CRT-D Cardiac Resynchronization Therapy Devices

INSTRUCTION MANUAL

MODEL: CDHFA500T

Product Highlights

Bluetooth® Low Energy (LE) communication enabling smartphone connectivity through data encryption
MultiPoint™ pacing delivers multiple LV pacing pulses per cardiac cycle in both LV only and BiV pacing modes
SyncAV™ Plus CRT technology offers dynamic AV timing with adaptive programming to ensure BiV pacing with or without MultiPoint pacing
Improved shape with reduced volume and thickness
40J delivered energy safety shock option for enhanced safety margin
DeFT Response™ technology offers noninvasive programming options to optimize rescue therapy to each patient’s unique physiology and changing conditions
VF Therapy Assurance decreases the time to treatment for arrhythmias in patients who are likely to be hemodynamically unstable
Antitachycardia pacing (ATP) while charging and prior to charging in the VF zone further extends the programming options for terminating tachyarrhythmias without a high-voltage shock
ShockGuard™ technology with DecisionTx™ programming is designed to reduce inappropriate therapy and minimize the need for programming adjustments at implant
– SecureSense™ RV lead noise discrimination algorithm detects sustained lead noise and short bursts of oversensing that would otherwise go unnoticed or potentially lead to one or more inappropriate shocks
– Far Field MD™ morphology discrimination and chamber onset discrimination enhances SVT and VT discrimination for reduced inappropriate therapies
SenseAbility™ sensing algorithm feature provides the flexibility to fine-tune programming around T-wave oversensing without decreasing sensitivity
The Gallant HF CRT-D and Quartet™ quadripolar
LV lead feature four pacing electrodes and 13 pacing vectors to provide more options and greater control to address implant complications such as diaphragmatic stimulation and high pacing thresholds
Easily test and program with Auto VectSelect Quartet™ multivector testing, offering an efficient workflow for complete results and programming
DynamicTx™ over-current detection algorithm automatically changes shock configurations to ensure delivery of high-voltage therapy when high current is detected
MRI-Ready device tested in combination with
MR Conditional leads for full-body scans using a 1.5T or 3T (Tesla) field strength MRI Scanner*
The CorVue™ thoracic impedance feature measures transthoracic impedance changes over time to provide additional insight into the patient’s heart failure condition
Cold can programmability provides an additional RV-SVC shock configuration to decouple the can from the shocking vector parameters in cases of lead problems
Premature Atrial Contraction (PAC) Response to avoid pacing the atrium in a vulnerable zone
Physiologic rate responsive AV Delay and PVARP
QuickOpt™ timing cycle optimization provides quick and effective optimization at the push of a button
Dual patient notification: audio notification through the device and visual notification via myMerlinPulse app

Ordering Information

Contents: Cardiac Pulse Generator

MODEL NUMBER| DIMENSIONS (L × W × H) (MM)| WEIGHT (G)| VOLUME (CC)| CONNECTOR DEFIBRILLATION| CONNECTOR SENSE/PACE| CONNECTOR PACE – LEFT VENTRICLE
---|---|---|---|---|---|---
CDHFA500T| 79 × 51 × 12| 77| 37| DF-1| IS-1| IS-4

*See MRI Scan Parameters in MRI-Ready Systems Manual.

Product Specifications

PARAMETER SPECIFICATIONS

Model| CDHFA500T
Telemetry| Bluetooth® LE Communication
Delivered/Stored Energy| 40/45 J
Volume| 37 cc
Weight| 77 g
Size| 79 × 51 × 12 mm
Defibrillation Lead Connection| DF-1
Atrial Sense/Pace Lead Connection| IS-1 in-line bipolar
Ventricular Sense/Pace Lead Connection| IS-1 in-line bipolar
Left Ventricular Pace Lead Connection| IS4-LLLL
High Voltage Can| Electrically active titanium can
Parameter| Settings
Biventricular Pacing|
VectSelect Quartet™ Programmable
LV Pulse Configuration| Distal Tip 1 – Mid 2; Distal Tip 1 – Proximal 4; Distal Tip 1 – Mid 3; Distal Tip 1 – RV Coil; Mid 2 – Mid 3; Mid 2 –
Proximal 4; Mid 2 – RV Coil; Mid 3 – Mid 2; Mid 3 – Proximal 4; Mid 3 – RV Coil; Proximal 4 – Mid 2; Proximal
4 – Mid 3: Proximal 4 – RV Coil
MultiPoint™ Pacing| LV1, LV2
Delay MultiPoint Pacing| Delay 1: 5; 10; … 80 ms
Delay 2: 5; 10; … 50 ms
V. Triggering| On; Off
QuickOpt™ Timing Cycle Optimization| Sensed/Paced AV delay, Interventricular pace delay
V-V Timing| Simultaneous†; RV First; LV First
Interventricular Pace Delay| RV First 10–80/LV First 15–80 ms
Ventricular Sensing| RV only (not programmable)
Ventricular Pacing Chamber| RV only; LV only; Biventricular
SyncAV™ Plus CRT Technology Delta| If Type = Percentage: -10; – 15;…-70% If Type = Fixed: -10; -20;…-120 ms; Off
MPP PVAB| 125-260 ms
AF Management|
AF Suppression™ Pacing| On; Off
No. of Overdrive Pacing Cycles| 15-40
Maximum AF Suppression Rate| 80-150 bpm

Product Specifications

Sensing/Detection|
---|---
SenseAbility™ Sensing Algorithm| Automatic sensitivity control adjustment for atrial and ventricular events
Low Frequency Attenuation| On; Off
Threshold Start| Post-Sensed: 50; 62.5; 75; 100%
Post-Paced, Atrial: 0.2-3.0 mV
Post-Paced, Ventricular: Auto, 0.2-3.0 mV
Decay Delay| Post-Sensed: 0-220 ms
Post-Paced, Atrial: 0-220 ms
Post-Paced, Ventricular: Auto, 0-220 ms
Ventricular Sense Refractory| 125; 157 ms
Detection Zones| 3 zone programming — 1 zone; 2 zones; or 3 zones (VT-1; VT-2; VF)
SVT Discriminators| AV Rate Branch; Arrhythmia Onset (Chamber Onset or Sudden Onset); Interval Stability; AV Association Morphology; Discrimination (Far Field MD™ Morphology Discrimination or Original MD) with Automatic Template Update
Monitor Mode| Detection, discrimination, and diagnostics, no therapy delivery (VT or VT-1 zone)
Discrimination Modes| On; Passive; Off
SVT Upper Limit| 150-240 bpm
SVT Discrimination Timeout| 20s-60 min; Off
Reconfirmation| Continuous sensing during charging
SecureSense™ RV Lead Noise Discrimination Algorithm| On; On with Timeout; Passive; Off
VF Therapy Assurance| On; Off
Antitachycardia Pacing Therapy|
ATP Configurations| Ramp; Burst; Scan; 1 or 2 schemes per VT zone
ATP in VF Zone| ATP While Charging; ATP Prior to Charging; Off
ATP Upper Rate Cutoff| 150–300 bpm
Burst Cycle Length| Adaptive (50%-100%); Fixed (200-550 ms)
Min. Burst Cycle Length| 150-400 in increments of 5 ms
Readaptive| On; Off
Number of Bursts/Stimuli| 1-15 with 2–20 Stimuli
Add Stimuli per Burst| On; Off
ATP Pulse Amplitude| 7.5 V independent from bradycardia and post-therapy pacing
ATP Pulse Width| 1.0 or 1.5 ms independently programmable from bradycardia and post-therapy pacing
High-Voltage Therapy|
DynamicTx™ Over-current Detection Algorithm| On: Off
DeFT Response™ Technology| Programmable pulse width for P1/P2 and tilt
High-Voltage Output Mode| Fixed Pulse Width; Fixed Tilt
Waveform| Biphasic; Monophasic
RV Polarity| Cathode (-); Anode (+)
Electrode Configuration| RV to Can; RV to SVC/Can; RV to SVC
Bradycardia Pacing|
Permanent Modes| DDD(R); DDT(R); DDI(R); VVT(R); VVI(R); AAI(R); Off
Temporary Modes| DDD; DDT; DDI; VVT; VVI; AAI; AAT; DOO; VOO; AOO; Off
Activity Sensor| On; Passive; Off
Programmable Rate and Delay Parameters| Base Rate (bpm); Rest Rate (bpm); Maximum Tracking Rate (bpm); Max Trigger Rate (bpm); Maximum Sensor Rate (bpm); Paced AV Delay (ms); Sensed AV Delay (ms); Rate Responsive AV Delay; Hysteresis Rate (bpm); Rate Hysteresis with Search
Pulse Amplitude| 0.25-7.5 V
Pulse Width| 0.05, 0.1-1.5 ms
LVCap™ Confirm Feature, LVCap™ 2 Confirm Feature| Setup; On; Monitor; Off
RVCap™ Confirm Feature| Setup; On; Monitor; Off

Bradycardia Pacing|
---|---
ACap™ Confirm Feature| On; Monitor; Off
Auto Mode Switch (AMS)| DDI(R); DDT(R); VVI(R); VVT(R); Off
Atrial Tachycardia Detection Rate| 110-300 bpm
AMS Base Rate| 40; 45; … 135 bpm
PMT Detection/Termination| Atrial Pace; Passive; Off
Rate Responsive PVARP| Low; Medium; High; Off
Rate Responsive V Pace Refractory| On; Off
PAC Response| On; Off
PAC Response interval| 200-400 ms
Shortest AV Delay| 25-120 ms
Post-Therapy Pacing (Independently programmable from Bradycardia and ATP)
Post-Shock Pacing Mode| AAI; VVI; DDI; or DDD; Off
Post-Shock Base Rate| 30-100 bpm
Post-Shock Pacing Duration| 0.5; 1; 2.5; 5; 7.5; or 10 min; Off
Device Testing/Induction Methods|
DC Fibber™ Induction Method Pulse Duration| 0.5-5.0 sec
Burst Fibber Cycle Length| 20-100 ms
Noninvasive Programmed Stimulation (NIPS)| 2-25 stimuli with up to 3 extra stimuli
Patient Notifiers|
Programmable Notifiers (On; Off)| BatteryAssurance™ alert; Possible HV circuit damage; HV charge timeout; Long charge time for Capacitor Maintenance; Device at ERI; Atrial pacing lead impedance out of range. Ventricular pacing lead impedance out of range; High-voltage lead impedance out of range; AT/AF Episode duration; AT/AF Burden; High ventricular rate during AT/AF; SecureSense™ lead noise detection; Non-sustained ventricular oversensing; Ventricular pacing percentage greater than limit.
Device Parameter Reset| On
Entry into Backup VVI Mode| On
Auditory Duration| 2; 4; 6; 8; 10; 12; 14; 16 sec
Number of Audio alerts per Notification| 2
Number of Notifications| 1–16
Time Between Notifications| 10; 22 hours
Electrograms and Diagnostics|
Stored Electrograms| 30 minutes (2 user programmable + discrimination channel), up to 1 minute programmable pre-trigger data per VT/VF electrograms; additional triggers include lead noise detection, non-sustained ventricular oversensing, morphology template updates, atrial episode, PMT termination, PAC response, magnet reversion, noise reversion
Therapy Summary| Diagram of therapies delivered
Episodes Summary| Directory listing of up to 60 episodes with access to more details including stored electrograms
Lifetime Diagnostics| History of bradycardia events and device-initiated charging
AT/AF Burden Trend| Trend data and counts
Ventricular HV Lead Impedance| Multi-Vector Trend Data
Histograms and Trends| Event Histogram; AV Interval Histogram; Mode Switch or AT/AF Duration Histogram; Peak Filtered Atrial Rate during Atrial Arrhythmia Histogram; Atrial Heart Rate Histogram; Ventricular Heart Rate Histogram; AT/AF Burden; Exercise and Activity Trending; V Rates during AMS; DirectTrend™ reports up to 1 year
PMT Data| Information regarding PMT detections
Real-Time Measurements (RTM)| Pacing lead impedances; High-voltage lead impedances; Signal amplitudes
CorVue Thoracic Impedance| On; Off
CorVue Thoracic Impedance Threshold| 8-18 days

MRI Settings|
---|---
Tachy Therapy| Disabled
MRI Mode| DOO; VOO; AOO; Pacing Off
MRI Base Rate| 30-100 bpm
MRI Paced AV Delay| 25-110 ms
MRI RA and RV Pulse Amplitude| 5.0 or 7.5 V
MRI RA and RV Pulse Width| 1.0 ms
MRI RA and RV Pulse Configuration| Bipolar
MRI LV Pulse Configuration| D1-M2, D1-M3, D1-P4, M2-M3, M2-P4, M3-M2, M3-P4, P4-M2, P4-M3
MRI LV Pulse Amplitude| 0.25-7.5 V
MRI LV Pulse Width| 0.05-1.5 ms
MRI V Pacing Chamber| RV Only, LV+RV (Simultaneous)
MRI Timeout| 3; 6; 9; 12; 24 hours; Off

MRI SCAN PARAMETERS†

Lead Model| Magnet (Tesla)| RF Transmit Conditions| Scan Region
Durata™ Defibrillation Lead| 1.5 T / 3 T| Normal Operating Mode| Full-body
7120 (lead lengths: 60, 65 cm)
7122 (lead lengths: 60, 65 cm)
Optisure™ Lead| 1.5 T / 3 T
LDA220 (lead lengths: 60, 65 cm)
LDA210 (lead lengths: 60, 65 cm)
Quartet™ LV Lead| 1.5 T / 3 T
1456Q (lead length: 86 cm)
1457Q (lead length: 86 cm)
1458Q (lead length: 86 cm)
1458QL (lead length: 86 cm)
Tendril™ STS Pacing Lead| 1.5 T / 3 T
2088TC (lead lengths: 46, 52 cm)
Tendril MRI™ Lead| 1.5 T
LPA1200M (lead lengths: 46, 52 cm)
UltiPace Pacemaker Lead| 1.5 T / 3 T
LPA1231 (Lead lengths46, 52 cm)

† LV first with 10 ms interventricular delay.
For additional information about specific MR Conditional CRT-Ds and leads, including scan parameters, warnings, precautions, adverse conditions to MRI scanning, and potential adverse events,
please refer to the Abbott MRI-Ready Systems Manual at medical.abbott/manuals.

CDHFA500T Rx Only

Brief Summary: This product is intended for use by or under the direction of a Physician. Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Intended Use: The Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are intended to provide ventricular antitachycardia pacing and ventricular cardioversion/defibrillation. The CRT-D devices are also intended to resynchronize the right and left ventricles.

The myMerlinPulse™ mobile application is intended for use by people who have an Abbott Medical implanted heart device and access to a mobile device. The app provides remote monitoring capability of the implanted heart device by transmitting information from the patient’s implanted heart device to the patient’s healthcare provider.

Indications: The CRT-D devices are indicated for automated treatment of life-threatening ventricular arrhythmias. CRT-D devices are also indicated to treat symptoms in patients who have congestive heart failure with ventricular dyssynchrony.

In addition, dual chamber CRT-D devices with the AT/AF detection algorithm are indicated in patients with atrial tachyarrhythmias or those patients who are at significant risk of developing atrial tachyarrhythmias.

MR Conditional CRT-Ds are conditionally safe for use in the MRI environment when used in a complete MR Conditional system and according to instructions in the MRI-Ready Systems manual. Scanning under different conditions may result in severe patient injury, death or device malfunction.

The myMerlinPulse™ mobile application is indicated for use by patients with supported Abbott Medical implanted heart devices.

Contraindications: Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction.

The myMerlinPulse™ mobile application is contraindicated for use with any implanted medical device other than supported Abbott Medical implanted heart devices.

Adverse Events: Possible adverse events associated with the implantation of the pulse generator system include the following: Arrhythmia (for example, accelerated or induced), Bradycardia, Cardiac or venous perforation, Cardiac tamponade, Cardiogenic shock, Death, Discomfort, Embolism, Endocarditis, Erosion, Exacerbation of heart failure, Excessive fibrotic tissue growth, Extracardiac stimulation (phrenic nerve, diaphragm, pectoral muscle), Extrusion, Fluid accumulation within the device pocket, Formation of hematomas, cysts, or seromas, Heart block, Hemorrhage, Hemothorax, Hypersensitivity, including local tissue reaction or allergic reaction, Infection, Keloid formation, Myocardial damage, Nerve damage, Occlusion/Thrombus, Pericardial effusion, Pericarditis, Pneumothorax, Pulmonary edema, Syncope, Thrombosis, Valve damage. Complications reported with direct subclavian venipuncture include pneumothorax, hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation of other vessels, massive hemorrhage and rarely, death. Among the psychological effects of device implantation are imagined pulsing, depression, dependency, fear of premature battery depletion, device malfunction, inappropriate pulsing, shocking while conscious, or losing pulse capability. Possible adverse device effects include complications due to the following: , Abnormal battery depletion, Conductor fracture, Device- programmer communication failure, Elevated or rise in defibrillation/cardioversion threshold, Inability to defibrillate or pace, Inability to interrogate or program due to programmer or device malfunction, Incomplete lead connection with pulse generator, Inhibited therapy including defibrillation and pacing, Inappropriate therapy (for example, shocks and antitachycardia pacing [ATP] where applicable, pacing), Interruption of function due to electrical or magnetic interference, Intolerance to high rate pacing (for example dyspnea or discomfort), Lead abrasion, Lead fracture, Lead insulation damage, Lead migration or lead dislodgement, Loss of device functionality due to component failure, Pulse generator migration, Rise in DFT threshold, Rise in pacing threshold and exit block, Shunting of energy from defibrillation paddles, System failure due to ionizing radiation. Additionally, potential adverse events associated with the implantation of a coronary venous lead system include the following: Allergic reaction to contrast media, Breakage or failure of implant instruments, Prolonged exposure to fluoroscopic radiation, Renal failure from contrast media used to visualize coronary veins. Refer to the User’s Manual for detailed intended use, indications, contraindications, warnings, precautions and potential adverse events.

No potential adverse events have been identified with use of the myMerlinPulse™ mobile application.

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MAT-2400585 v1.0 | Item approved for U.S. only.