NCT00146874

Brief Summary

This registry will provide detailed patient demographics and characteristics at the time of enrollment and will also provide data regarding predictors of clinical outcomes such as heart failure decompensation, heart failure hospitalization, NYHA class, and quality of life.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ 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

May 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Last Updated

August 18, 2010

Status Verified

November 1, 2006

Enrollment Period

2.8 years

First QC Date

September 2, 2005

Last Update Submit

August 17, 2010

Conditions

Heart Failure

Interventions

cardiac resynchronization therapyDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Standard CRT population

You may qualify if:

  • Patients who meet current indications for the CONTAK RENEWAL® family of CRT-P or CRT-D devices
  • Patients who receive either transvenous Guidant manufactured ventricular leads or non-Guidant epicardial leads
  • Patients who have had an ejection fraction measured within six months of enrollment
  • Patients who sign and date a Patient Informed Consent form at the enrollment visit
  • Patients who remain in the clinical care of the enrolling physician in approved centers

You may not qualify if:

  • Patients who are expected to receive a heart transplant during the duration of the registry
  • Patients who currently have or who are likely to receive a tricuspid valve prosthesis
  • Patients who are currently enrolled in another observational registry or investigational study that would directly impact the treatment or outcome of the CRT RENEWAL Registry. Each instance will be brought to the attention of Guidant's Clinical Application Research Studies (CARS) Department to determine eligibility
  • Patients who are younger than 18 years of age
  • Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the registry
  • Patients who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Study Officials

  • Andrew Kaplan, MD

    Tri-City Cardiology Consultants

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

May 1, 2004

Primary Completion

March 1, 2007

Last Updated

August 18, 2010

Record last verified: 2006-11