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

Medtronic Cardiac Rhythm and Heart Failure52 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Heart Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Ronald Lo, Inc.

Riverside, California, United States

Orlando Health

Orlando, Florida, United States

Essentia Institute of Rural Health

Duluth, Minnesota, United States

Methodist DeBakey Cardiology Associates

Houston, Texas, United States

Outcomes

Primary Outcomes

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

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.

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

Secondary Outcomes

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

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.

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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.