Cutaneous Heart Sounds Data Collection During Cardiac Resynchronization Therapy (CRT) Optimization Study

Cutaneous Heart Sounds Data Collection During CRT Optimization Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01609985

Enrollment

Registered

2012-06-01

Start date

2012-03-31

Completion date

2012-12-31

Last updated

2013-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Cardiac Resynchronization Therapy Defibrillator (CRT-D) Devices

Brief summary

The Cutaneous Heart Sounds Data Collection During CRT Optimization study is an acute, prospective, non-randomized multi-center feasibility clinical trial. The purpose of this clinical trial is to collect data to assist in the testing and finalization of a hemodynamic sensor-based cardiac resynchronization therapy (CRT) optimization scheme.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject must have been implanted with a Medtronic market approved CRT-D device (Concerto®, Concerto® II, Maximo® II, Consulta®, Protecta™, or Protecta™ XT) within two years * Subject must be 18 years of age or older * Subject or his/her legally authorized representative has signed and dated the study specific informed consent form (Consent Form) * Subject is willing and able to comply with protocol requirements

Exclusion criteria

* Subject with atrial tachyarrhythmia or frequent atrial or ventricular ectopy * Subject is post mitral or aortic valve repair or replacement * Subject is participating in other research studies that many confound the results of this study * Subject is pregnant or in fertile age without secure birth control * Subject has dementia * Subject is unwilling to comply with protocol requirements * Subject has a device and lead system with fractured leads * Subject cannot undergo an echocardiograph procedure, or is contraindicated to undergo such a procedure

Design outcomes

Primary

Measure	Time frame	Description
Collection of simultaneous cardiac signals representing heart sounds and CRT-D electrogram (EGM) vectors.	A two hour office visit within two years of CRT-Defibrillator (D) and lead system implant	The cardiac signals collected by the modified Virtuoso® ICD and implanted CRT-D EGM vectors will be used to determine how to improve and finalize a prototyped hemodynamic sensor-based CRT optimization scheme.

Secondary

Measure	Time frame	Description
Comparison of modified Virtuoso® Implantable Cardiac Defibrillator (ICD) heart sounds and CRT-D electrogram (EGM) vectors	A two hour office visit within two years of CRT-D and lead system implant	The heart sounds vector data from the externally affixed modified Virtuoso® ICD will be compared to the EGM vectors from the implanted CRT-D device after CRT optimization.
Determine if modified Virtuoso® ICD recorded heart sounds and CRT-D recorded EGM are able to detect phrenic nerve stimulation (PNS)	A two hour office visit within two years of CRT-D and lead system implant	—

Countries

United States

Outcome results