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

NCT01609985 | Completed

• 1 other identifier: Heart Sounds During CRT
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 5

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.

Conditions

Heart Failure

Keywords

Cardiac Resynchronization Therapy Defibrillator (CRT-D) Devices

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with an implanted Medtronic market approved CRT-D device.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (5)

Ronald Lo, Inc.

Riverside, California, 92501, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

Essentia Institute of Rural Health

Duluth, Minnesota, 55805, United States

Location

Methodist DeBakey Cardiology Associates

Houston, Texas, 77030, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Heart Sounds During CRT Clinical Trial Leader

  Medtronic CRDM Clinical

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: June 1, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 1, 2013

Record last verified: 2013-06

Locations

US (5)