RAPID-RF: Remote Active Monitoring in Patients With Heart Failure

NCT00334451 | Completed

• 2 other identifiers: CR-CA-030206-HRAPID RF
• Study Type: observational
• Target: 891
• Locations: 1 country
• Sites: 1

Brief Summary

The RAPID-RF Registry aims to characterize LATITUDE® Patient Management's alert feature: LATITUDE Active Monitoring™ by evaluating type and frequency of alert notifications and alert-related medical interventions. This registry will also assess clinical outcomes including quality of life and New York Heart Association Class changes over time, mortality, hospitalizations and heart failure-related event rates.

Conditions

Heart Failure

Keywords

Heart Failure; Remote Monitoring; Implantable Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinics, heart failure clinics, hospitals

You may qualify if:

• Patients who meet current indications for a Guidant RF-enabled CRT-D device (e.g. CONTAK RENEWAL 3 RF family of CRT-D devices) which is compatible with the LATITUDE Communicator. Indications include: NYHA Class III, IV; EF of ≤ 35%; QRS duration of ≥ 120 ms; and optimized pharmacologic therapy
• Patients who have an analog telephone line compatible with the LATITUDE Communicator. The LATITUDE Communicator must be placed within 8 feet of where they sleep for successful remote interrogations to occur.
• Patients who receive the study components including the LATITUDE Communicator, weight scale, and blood pressure monitor
• Patients who are willing and capable of providing informed consent prior to implant and willing to participate in the RAPID-RF Registry
• Patients who remain in the clinical care of a RAPID-RF investigator at approved centers

You may not qualify if:

• Patients who are expected to receive a heart transplant during the course of the study
• Patients who have received or who will receive a tricuspid valve prosthesis during the course of the study
• Patients who have previously received an implantable cardiac resynchronization device (e.g., biventricular pacemaker or biventricular ICD)
• Patients whose life expectancy is less than 12 months
• Patients who are currently enrolled in another observational registry or investigational study that could directly impact the treatment or outcome of the RAPID-RF Registry. Contact Guidant's Clinical Application Research Study (CARS) department to determine eligibility.
• Patients who are younger than 18 years of age
• Patients who are pregnant or plan to become pregnant during the study
• Patients who are unable or refuse to comply with the protocol requirements

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Related Publications (1)

• Saxon LA, Boehmer JP, Neuman S, Mullin CM. Remote Active Monitoring in Patients with Heart Failure (RAPID-RF): design and rationale. J Card Fail. 2007 May;13(4):241-6. doi: 10.1016/j.cardfail.2006.12.004.

  PMID: 17517341 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Leslie A Saxon, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

• John P Boehmer, MD

  Hershey Medical Center, Hershey, PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2006
• First Posted: June 7, 2006
• Study Start: May 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: February 24, 2014

Record last verified: 2014-02

Locations

US (1)