The HF-HRV Registry

NCT ID: NCT00236236

Last Updated: 2006-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-02-28

Study Completion Date

2005-05-31

Brief Summary

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The Registry will evaluate how HRV Monitor diagnostics change after cardiac resynchronization therapy in patients with heart failure.

Detailed Description

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Conditions

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Heart Failure Arrhythmia

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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Cardiac Resynchronization Therapy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients receiving their first CRT-D
* Patients who sign and date a Patient Informed Consent prior to device implant
* Patients who are available and willing to attend follow-up visits at the study center in which they were enrolled

Exclusion Criteria

* Patients who are anticipated to receive pacing modes other than DDD or VDD (i.e., chronic atrial fibrillation patients are excluded), or patients who are anticipated to receive adaptive rate therapy
* Patients who are younger than 18 years of age
* Patients whose life expectancy is less than six-months due to other medical conditions
* Patients with or who are likely to receive a tricuspid or other valve prosthesis
* Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study
* Women who are pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role lead

Principal Investigators

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Kellie Chase

Role: STUDY_CHAIR

Guidant Corporation

Other Identifiers

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CR-CA-022103-H

Identifier Type: -

Identifier Source: org_study_id