NCT00500838

Brief Summary

The intent of this feasibility study is to collect and analyze intra-thoracic impedance measurements from a CRT-D device in a heart failure population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Jul 2007

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

4 active sites

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

July 1, 2007

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

1.1 years

First QC Date

July 11, 2007

Last Update Submit

January 31, 2019

Conditions

Heart Failure

Keywords

Cardiac Resynchronization TherapyTransthoracic Impedance

Outcome Measures

Primary Outcomes (1)

  • To assess the use of the impedance feature in conjunction with other functions of the CRT-D device

    6 months

Study Arms (1)

1

EXPERIMENTAL

Transthoracic impedance device implanted.

Device: Transthoracic Impedance

Interventions

Transthoracic ImpedanceDEVICE

Impedance measures will be automatically collected via the device

1

Eligibility Criteria

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

You may qualify if:

  • Eligible patients will meet all of the following:
  • Have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a Cardiac Resynchronization Therapy Defibrillator (CRT-D) or have a previously implanted St. Jude Medical (SJM) CRT-D system capable of enabling the diagnostic impedance monitoring feature with implant occurring within the last 14 days
  • Have had at least one hospitalization, emergency department visit, or clinic visit within the past 12 months for treatment of decompensated heart failure requiring intravenous diuretics, intravenous inotropes, Natrecor (Nesiritide) therapy, or an increase in an oral diuretic of ≥100% over a 24 hour period
  • Have the ability to maintain a patient diary for recording daily weights, symptoms related to heart failure, changes in diuretic therapy, and any unscheduled clinic or hospital visits
  • Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluation

You may not qualify if:

  • Patients will be excluded if they meet any of the following:
  • Be less than 18 years of age
  • Have had a recent myocardial infarction, unstable angina or cardiac revascularization within 40 days of enrollment
  • Have had a recent Cerebrovascular Accident or Transient Ischemic Attack within three months of enrollment
  • Have a contraindication for an emergency thoracotomy
  • Have an indication that requires programming device in atrial pacing mode
  • Have permanent (chronic) atrial fibrillation
  • Have a capped or inactive right atrial or right ventricular pacing/defibrillator lead
  • Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
  • Be pregnant or planning a pregnancy in the next 6-months
  • Be currently participating in a clinical investigation that includes an active treatment arm
  • Have a life expectancy of less than six months due to any condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Baptist Health Medical Center

Little Rock, Arkansas, 72205, United States

Location

Glendale Memorial Hospital

Glendale, California, 91204, United States

Location

Deborah Heart and Lung

Browns Mills, New Jersey, 08015, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29401, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiography, Impedance

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisPlethysmography, ImpedancePlethysmography

Study Officials

  • G. Stephen Greer, MD

    Baptist Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2007

First Posted

July 13, 2007

Study Start

July 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations

US(4)