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

Completed

• Conditions: Heart Failure

• Registration Number: NCT01609985
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-28
• Study First Submitted QC: 2012-05-30
• Study First Posted: 2012-06-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-28
• Last Update Posted: 2013-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Ronald Lo, Inc.; 🇺🇸 Riverside, California, United States

Essentia Institute of Rural Health; 🇺🇸 Duluth, Minnesota, United States

Methodist DeBakey Cardiology Associates; 🇺🇸 Houston, Texas, United States

Orlando Health; 🇺🇸 Orlando, Florida, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States