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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ronald Lo, Inc., Riverside, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Collection of simultaneous cardiac signals representing heart sounds and CRT-D electrogram (EGM) vectors.

Time frame: 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 outcomes

Comparison of modified Virtuoso® Implantable Cardiac Defibrillator (ICD) heart sounds and CRT-D electrogram (EGM) vectors

Time frame: 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)

Time frame: A two hour office visit within two years of CRT-D and lead system implant

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

Cutaneous Heart Sounds Data Collection During CRT Optimization Study

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Jun 1, 2012
Registry last updated: Jul 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed