NCT00236236

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2003

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
Last Updated

November 14, 2006

Status Verified

October 1, 2005

First QC Date

September 2, 2005

Last Update Submit

November 13, 2006

Conditions

Heart FailureArrhythmia

Interventions

Cardiac Resynchronization TherapyDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart FailureArrhythmias, Cardiac

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Study Officials

  • Kellie Chase

    Guidant Corporation

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 2, 2005

First Posted

October 12, 2005

Study Start

February 1, 2003

Study Completion

May 1, 2005

Last Updated

November 14, 2006

Record last verified: 2005-10