Heart FailureNCT01609985
Cutaneous Heart Sounds Data Collection During Cardiac Resynchronization Therapy (CRT) Optimization Study
An observational study of Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 52 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with an implanted Medtronic market approved CRT-D device.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Essentia Institute of Rural Health
Duluth, Minnesota, 55805
Methodist DeBakey Cardiology Associates
Houston, Texas, 77030
Orlando Health
Orlando, Florida, 32806
Virginia Commonwealth University
Richmond, Virginia, 23219
Ronald Lo, Inc.
Riverside, California, 92501
About this study
Official title: Cutaneous Heart Sounds Data Collection During 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.
- Conditions
- Heart Failure
- Keywords
- Cardiac Resynchronization Therapy Defibrillator (CRT-D) Devices
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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)
Measured: A two hour office visit within two years of CRT-D and lead system implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Heart Sounds During CRT Clinical Trial Leader, Study chair, Medtronic CRDM Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609985
- Sponsor's protocol ID
- Heart Sounds During CRT
- Status last verified
- Jun 2013
- First submitted
- 28 Mar 2012
- Last updated
- 1 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutaneous Heart Sounds Data Collection During CRT Optimization Study
- ClinicalTrials.gov ID
- NCT01609985
- Acronym / sponsor ID
- Heart Sounds During CRT
- Conditions
- Heart Failure
- Keywords
- Cardiac Resynchronization Therapy Defibrillator (CRT-D) Devices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with an implanted Medtronic market approved CRT-D device.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2013.
Related trials for Heart Failure
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heart Sounds During CRT Clinical Trial Leader study chair
Medtronic CRDM Clinical
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2013.