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ALTITUDE SM


ALTITUDE Clinical Science ProgramStatus: Ongoing

 

The ALTITUDE clinical science program is analyzing comprehensive data from the LATITUDE® Patient Management system to provide insight into meaningful questions related to implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) therapy. The ALTITUDE program is managed in collaboration with an external physician panel of thought leaders who assist in identifying relevant clinical issues for analysis.

Boston Scientific has enrolled over 150,000 patients on the LATITUDE system since its introduction in 2006. The database has had over 7 million transmissions, making it a very large source of data from a non-selected patient population that is 20 times the enrollment of most clinical trials.

The LATITUDE system allows physicians to schedule remote follow-ups of implantable cardiac devices to monitor specific device information and patient heart health status. It can also detect clinical events physicians.

 


 

Results

 

Presented Abstracts


HRS 2010

HRS 2009

  • Survival After ICD and CRT-D Implant in A Large Cohort of Heart Failure Patients Treated with Contemporary Drug and Device Therapies -Results of the ALTITUDE Study - ALTITUDE Late-Breaker  

Users can view this abstract by visiting the following website URL: http://www.hrsonline.org/Sessions/ScientificProgram/late_breaking.cfm

 

  • Percent Biventricular Pacing Impacts Mortality in Heart Failure Patients
  • Right Ventricular Pacing Impacts Mortality in a Large Cohort of ICD Recipients


HFSA 2009

  • The Relationship of the LATITUDE Patient Symptom Report to Heart Failure Hospitalization


AHA 2009

  • Home Blood Pressure Monitoring Provides Important Prognostic Information in Patients Treated with a Cardiac Resynchronization Therapy Defibrillator


HRS 2008

  • Shock Incidence and Device Programming in the LATITUDE Patient Cohort
  • Do Acute changes in Blood Pressure Predict an Atrial Tachycardia Response (ATR) Episode
  • The Relationship of Heart Failure and Atrial Arrhythmias as Measured by Acute Changes in Weight and Atrial Tachycardia Response (ATR) Episodes
  • Performance of the Medtronic Sprint Fidelis® Lead on the LATITUDE Patient Network
  • Atrial high rate episodes of Varying Durations Across Time in the LATITUDE Patient Cohort


HFSA 2008

  • Durability of Weight and Blood Pressure Measurement Compliance Using an Internet-Based Patient Management System


AHA 2008

  • Is Latitude Remote ICD Follow up Associated with a Reduced Mortality?

 

 

Design

  • The ALTITUDE clinical science program benefits physicians by enhancing their understanding of device therapy, outcomes, and disease progression in the real-world device patients connected by LATITUDE.  
  • The ALTITUDE program is managed in collaboration with an external physician panel who assists in identifying relevant clinical issues for analysis. 

 

Patient Population

  • ALTITUDE is a retrospective, non-randomized, postmarket analysis of real-world data from the over 150,000 patients enrolled in the LATITUDE Patient Management system.    
  • The ALTITUDE program is managed in collaboration with an external physician panel who assist in identifying relevant clinical issues and patient populations for analysis.

 

Clinical Relevance

 

  • The ALTITUDE project will evaluate patterns of use, incidence of events, and the application of device therapy from LATITUDE to answer clinical and epidemiological questions related to understanding CRM device therapy in real-world practice.
  • JIF# CRM6-3601-0210

 

Brief Summary

LATITUDE® Patient Management System from Boston Scientific CRM


Intended Use

The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible pulse generator from Boston Scientific CRM and transfer data to a central database.

 

 

Contraindications

The LATITUDE system is contraindicated for use with any pulse generator other than a compatible pulse generator from Boston Scientific CRM. Not all Guidant or Boston Scientific pulse generators are compatible with the LATITUDE system. For contraindications for use related to the Guidant or Boston Scientific pulse generator, refer to the System Guide for the pulse generator being interrogated.

 

 

Precautions

The LATITUDE system is designed to notify clinicians within 24 hours if new pulse generator alert conditions are detected by the Communicator. Alert notifications are based on clinician configured alert settings. Pulse generator data will typically be available for review on the LATITUDE system within 15 minutes of a successful interrogation. However, data availability and alert notification can take up to 24 hours or the next business day. Note that data will not be available and alert notification cannot occur if:

 

  • The Communicator is unplugged or is not able to connect to the LATITUDE system through an active phone line.
  • The pulse generator and the Communicator cannot establish and complete a telemetry session. This session must be initiated by the patient if he or she has a pulse generator that uses inductive telemetry.
  • The Communicator becomes damaged or it malfunctions.
  • The patient is not compliant with prescribed use or is not using the LATITUDE system as described in the patient manual.

Up to two weeks may elapse before LATITUDE first detects the conditions mentioned above and additional time may be required for clinic notification and resolution of the condition. During this time, no new patient data, device data, or alert notifications since the last successful data transmission will be available.

Alert notifications are not intended to be used as the sole basis for making decisions about patient medical care. Alerts can be verified by reviewing supporting diagnostic information stored in the implanted device and viewing information on the LATITUDE clinician website.

 

Adverse Effects

None known.

 

Refer to the product labeling for specific instructions for use. Rx only.
(Rev. J)

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In the News

Read the New York Times article about cardiac device and remote monitoring technologies. The story features ALTITUDESM physician panel chair, Dr. Leslie Saxon, describing remote monitoring and associated published and unpublished data on increased survival rates for patients enrolled in remote monitoring compared to patients not enrolled in remote monitoring.

  Go to the article

 

Downloadable Resource

Download slide deck for the ALTITUDE Study

  ALTITUDE Study Slides (PPT)

 

ALTITUDE Physician Panel

External physician panel of thought leaders who assist in identifying relevant clinical issues for analysis

  Physician Panel

 

Important Risk Information

 

1 - Analysis of aggregate limited data-set from LATITUDE Patient Management System data as of 6/08/09. Data on file.

CRM10-1525-1109

DAS0008-52