Dynamic Thoracic Impedance as a Marker for Heart Failure Decompensation

NCT ID: NCT02134379

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 11 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-01-31

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.

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.

Conditions

Heart Failure; With Decompensation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Heart Failure

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

Medtronic ICDs, CRT-Ds, and CRT-Ps

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention 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)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Charles Porter, MD

OTHER

Sponsor Role: lead

Responsible Party

Charles Porter, MD

Clinical Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Charles Porter, MD, FACC, FACP

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

STUDY00000596

Identifier Type: -

Identifier Source: org_study_id