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

NCT ID: NCT00334451

Last Updated: 2014-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 891 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2008-07-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslie A Saxon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

John P Boehmer, MD

Role: PRINCIPAL_INVESTIGATOR

Hershey Medical Center, Hershey, PA

Locations

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 17517341 (View on PubMed)

Other Identifiers

RAPID RF

Identifier Type: -

Identifier Source: secondary_id

CR-CA-030206-H

Identifier Type: -

Identifier Source: org_study_id