Dynamic Thoracic Impedance as a Marker for Heart Failure Decompensation

Sponsor

Charles Porter, MD (Other)

Overall Status

Completed

CT.gov ID

NCT02134379

Collaborator

Medtronic (Industry)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This pilot study proposes to perform measurements of approved thoracic impedance technology that will help answer questions in patients with decompensated heart failure.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; With Decompensation	Device: Medtronic ICDs, CRT-Ds, and CRT-Ps

Detailed Description

Improved metrics derived from the transthoracic impedance (Z) available from implanted Medtronic devices may provide more sensitive indicators of the state of compensation for heart failure patients. Quantification of specific data may provide new information that can improve quality of life for patients and offer vital information to clinicians regarding the adequacy of inpatient and outpatient assessment and management of acute decompensated heart failure.

Study Design

Study Type:

Observational

Actual Enrollment :

11 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Dynamic Thoracic Impedance as a Marker for Heart Failure Decompensation: A Pilot Trial of the "Dynamic Thoracic Impedance Bed Rest Test"

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Heart Failure Subjects have implanted Medtronic device and a primary diagnosis of left ventricular systolic dysfunction	Device: Medtronic ICDs, CRT-Ds, and CRT-Ps Any Medtronic implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device. Device must have capacity to measure thoracic impedance as described in protocol. This includes the majority of FDA-approved Medtronic devices currently in use. Other Names: ICDs: Evera(TM) XT DR (Models DDBB1D4, DDBB1D1) Evera(TM) XT VR (Models DVBB1D4, DVBB1D1) Protecta(R) XT DR (Models D314DRG, D314DRM) Protecta(R) XT VR (Models D314VRG, D314VRM) Secura(R) DR (Models D224DRG, D204DRM) Secura(R) VR (Models D224VRC, D204VRM) Virtuoso(R) II DR (Model D274DRG) Virtuoso(R) II VR (Model D274VRC) Virtuoso(R) DR (Model D154AWG) Virtuoso(R) VR (Model D154VWC) CRT-Ds/CRT-Ps: Viva(TM) XT CRT-D (Models DTBA1D1, DTBA1D4) Viva(TM) S CRT-D (Models DTBB1D1, DTBB1D4) InSync Sentry(R) CRT-D (Models 7297, 7299) Protecta(R) XT CRT-D (Models D314TRM, D314TRG) Concerto(R) II CRT-D (Model D274TRK) Consulta(R) CRT-D (Models D204TRM, D224TRK) Concerto(R) CRT-D (Models C154DWK, C164AWK) Consulta(R) CRT-P (Model C4TR01)

Arm

Intervention/Treatment

Heart Failure

Subjects have implanted Medtronic device and a primary diagnosis of left ventricular systolic dysfunction

Device: Medtronic ICDs, CRT-Ds, and CRT-Ps

Any Medtronic implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device. Device must have capacity to measure thoracic impedance as described in protocol. This includes the majority of FDA-approved Medtronic devices currently in use.

Other Names:

ICDs:

Evera(TM) XT DR (Models DDBB1D4, DDBB1D1)

Evera(TM) XT VR (Models DVBB1D4, DVBB1D1)

Protecta(R) XT DR (Models D314DRG, D314DRM)

Protecta(R) XT VR (Models D314VRG, D314VRM)

Secura(R) DR (Models D224DRG, D204DRM)

Secura(R) VR (Models D224VRC, D204VRM)

Virtuoso(R) II DR (Model D274DRG)

Virtuoso(R) II VR (Model D274VRC)

Virtuoso(R) DR (Model D154AWG)

Virtuoso(R) VR (Model D154VWC)

CRT-Ds/CRT-Ps:

Viva(TM) XT CRT-D (Models DTBA1D1, DTBA1D4)

Viva(TM) S CRT-D (Models DTBB1D1, DTBB1D4)

InSync Sentry(R) CRT-D (Models 7297, 7299)

Protecta(R) XT CRT-D (Models D314TRM, D314TRG)

Concerto(R) II CRT-D (Model D274TRK)

Consulta(R) CRT-D (Models D204TRM, D224TRK)

Concerto(R) CRT-D (Models C154DWK, C164AWK)

Consulta(R) CRT-P (Model C4TR01)

Outcome Measures

Primary Outcome Measures

Change from sitting to supine to standing in thoracic impedance [Baseline, 30 Days]
thoracic impedance will be measured at each position at baseline visit then again at the follow-up visits through 30 days

Secondary Outcome Measures

Rate of change in thoracic impedance [Baseline, 30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with systolic dysfunction
Able to provide informed consent
Have a Medtronic manufactured device with Thoracic Impendence Monitoring capabilities

Exclusion Criteria:

Patients with severe congestive heart failure who are intubated
Patients who are oxygen dependent on continuous positive or bilevel positive ventilation
Inability to tolerate postural variations due to congestive heart failure or other medical or surgical condition.Unable to complete proposed testing
Subjects who cannot giveWill not give written, informed consent on their own behalf