Heart FailureHeartlogicNCT07753135
Association of Heart Failure Aggravation and Device-based Sensor Parameters
An observational study of Heart Failure and Cardiomyopathy, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This is a prospective, multicenter, observational patient registry designed to evaluate the association between changes in device-based sensor parameters and heart failure (HF) aggravation in patients implanted with Boston Scientific implantable cardioverter-defibrillators (ICDs) or cardiac resynchronization therapy… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Failure, Cardiomyopathy
- What is being tested?
- ICD/CRT-D equipped with HeartLogic, Sleep Incline, and Apnea Scan functions
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2023to 31 Oct 2027
- How long will I take part?
- 15 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with heart failure or cardiomyopathy implanted with HeartLogic-enabled Boston Scientific ICD or CRT-D devices who are enrolled in the LATITUDE remote monitoring system. Participants are prospectively followed to evaluate the relationship between device-based sensor parameters and clinical heart failure outcomes.
Who may be able to join
- Adults aged 19 years or older who provide written informed consent (or consent from a legally authorized representative when applicable)
- Diagnosed with heart failure or cardiomyopathy Implanted with a commercially approved Boston Scientific implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) equipped with HeartLogic™, Sleep Incline, and Apnea Scan functions
- Enrolled in the LATITUDE™ (NXT 5.0 or later) remote monitoring system and willing to participate in scheduled remote monitoring and follow-up
Who cannot join
- Planned heart transplantation or implantation of a ventricular assist device (VAD), or history of VAD implantation within the previous 12 months
- Life expectancy of less than 1 year
- Inability or unwillingness to comply with the study protocol or follow-up requirements
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, multicenter, observational patient registry designed to evaluate the association between changes in device-based sensor parameters and heart failure (HF) aggravation in patients implanted with Boston Scientific implantable cardioverter-defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) equipped with HeartLogic™, Sleep Incline, and Apnea Scan functions. The study will prospectively collect remote monitoring and clinical follow-up data to determine whether changes in individual or combined device-based sensor parameters are associated with worsening HF events and to evaluate the clinical utility of remote monitoring for HF management.
Read the detailed description
Heart failure remains a leading cause of hospitalization and mortality worldwide, and early identification of clinical deterioration is essential for timely intervention. Contemporary cardiac implantable electronic devices (CIEDs) continuously collect physiological information that may provide early indicators of worsening HF. Individual device-derived parameters, including thoracic impedance, heart rate, respiratory rate, physical activity, and heart sounds, have been investigated for HF monitoring; however, the predictive performance of single parameters has been limited by relatively high false-positive rates.
HeartLogic™ is a multiparametric algorithm that integrates multiple physiological signals, including heart sounds (S1 and S3), thoracic impedance, respiratory rate, night heart rate, and physical activity, to estimate the risk of impending HF decompensation. Additional device-based diagnostic features, including Sleep Incline and Apnea Scan, may further reflect changes in congestion and respiratory status associated with worsening HF. The combined use of these device-based sensor parameters has the potential to improve risk stratification and facilitate earlier clinical intervention.
This prospective, multicenter observational registry will enroll approximately 500 adult patients with HF or cardiomyopathy who have undergone implantation of a commercially approved Boston Scientific ICD or CRT-D equipped with HeartLogic, Sleep Incline, and Apnea Scan functions. Participants will be followed for approximately 15 months using routine in-clinic device evaluations and monthly remote monitoring through the LATITUDE™ system as part of standard clinical care. Clinical events, device-derived physiological parameters, and routine clinical assessments will be prospectively collected.
The primary objective is to evaluate the association between changes in device-based sensor parameters and HF worsening events, including HF hospitalization, emergency department visits requiring intensification of HF therapy, or unplanned outpatient visits requiring modification of HF treatment. Secondary objectives include evaluating the association between device-based sensor parameters and recurrent HF hospitalization after discharge, atrial and ventricular arrhythmia events, cardiovascular mortality, stroke or systemic embolism, and assessing the clinical utility and patient satisfaction of remote monitoring using the LATITUDE™ platform.
- Conditions
- Heart Failure, Cardiomyopathy
- Being tested
- ICD/CRT-D equipped with HeartLogic, Sleep Incline, and Apnea Scan functions
- Medical subject headings
- Heart Failure, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD/CRT-D equipped with HeartLogic, Sleep Incline, and Apnea Scan functionsDevice
Commercially approved Boston Scientific implantable cardioverter-defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) equipped with HeartLogic, Sleep Incline, and Apnea Scan functions. Device-based physiological parameters are collected through routine device interrogation and remote monitoring using the LATITUDE system as part of standard clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure or Cardiomyopathy Patients with ICD/CRT-D | Adult patients with heart failure or cardiomyopathy implanted with a commercially approved Boston Scientific ICD or CRT-D equipped with HeartLogic, Sleep Incline, and Apnea Scan functions who are enrolled in this prospective observational registry. Receives: Device: ICD/CRT-D equipped with HeartLogic, Sleep Incline, and Apnea Scan functions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Device-Based Sensor Parameters Associated With Heart Failure Worsening Events
To evaluate the association between changes in device-based sensor parameters (including HeartLogic index, heart sounds, thoracic impedance, respiratory rate, night heart rate, physical activity, Sleep Incline, and Apnea Scan) and heart failure worsening events, defined as heart failure hospitalization, emergency department visits requiring intensification of heart failure therapy, or unplanned outpatient visits requiring modification of heart failure treatment.
Measured: From enrollment through the 15-month follow-up period
Secondary outcomes (5)
Heart Failure Rehospitalization After Index Heart Failure Hospitalization
To evaluate the association between device-based sensor parameters measured within 3 days before hospital discharge and subsequent heart failure rehospitalization within 1 month or 3 months after discharge.
Measured: Up to 3 months after discharge
Cardiac Arrhythmia Events
To evaluate the association between changes in device-based sensor parameters and cardiac arrhythmia events, including newly detected atrial fibrillation, atrial fibrillation progression, atrial fibrillation burden, ventricular tachycardia, and ventricular fibrillation.
Measured: From enrollment through the 15-month follow-up period
Cardiovascular Mortality
To evaluate the association between changes in device-based sensor parameters and cardiovascular death.
Measured: From enrollment through the 15-month follow-up period
Stroke or Systemic Embolism
To evaluate the association between changes in device-based sensor parameters and stroke, transient ischemic attack, or systemic embolic events.
Measured: From enrollment through the 15-month follow-up period
Clinical Utility of Remote Monitoring
To evaluate the clinical utility of the LATITUDE remote monitoring system, including patient satisfaction assessed using the Home Monitoring Acceptance and Satisfaction Questionnaire (HoMASQ).
Measured: At the end of the 15-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Feb 2023
- Primary completion8 Aug 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
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 Samsung Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 15 Months
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung-Jung Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753135
- Sponsor's protocol ID
- SMC-2022-06-119
- Other IDs
- ISRRM12367
- Acronym
- Heartlogic
- Status last verified
- Jul 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Heart Failure Aggravation and Device-based Sensor Parameters
- ClinicalTrials.gov ID
- NCT07753135
- Acronym / sponsor ID
- Heartlogic / SMC-2022-06-119
- Conditions
- Heart Failure, Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 8 Aug 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 7 Aug 2026 (actual)
- 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.
This is a prospective, multicenter, observational patient registry designed to evaluate the association between changes in device-based sensor parameters and heart failure (HF) aggravation in patients implanted with Boston Scientific implantable cardioverter-defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) equipped with HeartLogic™, Sleep Incline, and Apnea Scan functions. The study will prospectively collect remote monitoring and clinical follow-up data to determine whether changes in individual or combined device-based sensor parameters are associated with worsening HF events and to evaluate the clinical utility of remote monitoring for HF management.
Detailed description
Heart failure remains a leading cause of hospitalization and mortality worldwide, and early identification of clinical deterioration is essential for timely intervention. Contemporary cardiac implantable electronic devices (CIEDs) continuously collect physiological information that may provide early indicators of worsening HF. Individual device-derived parameters, including thoracic impedance, heart rate, respiratory rate, physical activity, and heart sounds, have been investigated for HF monitoring; however, the predictive performance of single parameters has been limited by relatively high false-positive rates.
HeartLogic™ is a multiparametric algorithm that integrates multiple physiological signals, including heart sounds (S1 and S3), thoracic impedance, respiratory rate, night heart rate, and physical activity, to estimate the risk of impending HF decompensation. Additional device-based diagnostic features, including Sleep Incline and Apnea Scan, may further reflect changes in congestion and respiratory status associated with worsening HF. The combined use of these device-based sensor parameters has the potential to improve risk stratification and facilitate earlier clinical intervention.
This prospective, multicenter observational registry will enroll approximately 500 adult patients with HF or cardiomyopathy who have undergone implantation of a commercially approved Boston Scientific ICD or CRT-D equipped with HeartLogic, Sleep Incline, and Apnea Scan functions. Participants will be followed for approximately 15 months using routine in-clinic device evaluations and monthly remote monitoring through the LATITUDE™ system as part of standard clinical care. Clinical events, device-derived physiological parameters, and routine clinical assessments will be prospectively collected.
The primary objective is to evaluate the association between changes in device-based sensor parameters and HF worsening events, including HF hospitalization, emergency department visits requiring intensification of HF therapy, or unplanned outpatient visits requiring modification of HF treatment. Secondary objectives include evaluating the association between device-based sensor parameters and recurrent HF hospitalization after discharge, atrial and ventricular arrhythmia events, cardiovascular mortality, stroke or systemic embolism, and assessing the clinical utility and patient satisfaction of remote monitoring using the LATITUDE™ platform.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure or Cardiomyopathy Patients with ICD/CRT-D | – | Device: ICD/CRT-D equipped with HeartLogic, Sleep Incline, and Apnea Scan functionsAdult patients with heart failure or cardiomyopathy implanted with a commercially approved Boston Scientific ICD or CRT-D equipped with HeartLogic, Sleep Incline, and Apnea Scan functions who are enrolled in this prospective observational registry. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with heart failure or cardiomyopathy implanted with HeartLogic-enabled Boston Scientific ICD or CRT-D devices who are enrolled in the LATITUDE remote monitoring system. Participants are prospectively followed to evaluate the relationship between device-based sensor parameters and clinical heart failure outcomes.
Key inclusion criteria (3 listed)
- Adults aged 19 years or older who provide written informed consent (or consent from a legally authorized representative when applicable)
- Diagnosed with heart failure or cardiomyopathy Implanted with a commercially approved Boston Scientific implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) equipped with HeartLogic™, Sleep Incline, and Apnea Scan functions
- Enrolled in the LATITUDE™ (NXT 5.0 or later) remote monitoring system and willing to participate in scheduled remote monitoring and follow-up
Key exclusion criteria (3 listed)
- Planned heart transplantation or implantation of a ventricular assist device (VAD), or history of VAD implantation within the previous 12 months
- Life expectancy of less than 1 year
- Inability or unwillingness to comply with the study protocol or follow-up requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICD/CRT-D equipped with HeartLogic, Sleep Incline, and Apnea Scan functionsCommercially approved Boston Scientific implantable cardioverter-defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) equipped with HeartLogic, Sleep Incline, and Apnea Scan functions. Device-based physiological parameters are collected through routine device interrogation and remote monitoring using the LATITUDE system as part of standard clinical care. | Device | Heart Failure or Cardiomyopathy Patients with ICD/CRT-D |
Primary outcome
Change in Device-Based Sensor Parameters Associated With Heart Failure Worsening Events
Time frame: From enrollment through the 15-month follow-up period
To evaluate the association between changes in device-based sensor parameters (including HeartLogic index, heart sounds, thoracic impedance, respiratory rate, night heart rate, physical activity, Sleep Incline, and Apnea Scan) and heart failure worsening events, defined as heart failure hospitalization, emergency department visits requiring intensification of heart failure therapy, or unplanned outpatient visits requiring modification of heart failure treatment.
5 secondary outcomes
Heart Failure Rehospitalization After Index Heart Failure Hospitalization
Time frame: Up to 3 months after discharge
Cardiac Arrhythmia Events
Time frame: From enrollment through the 15-month follow-up period
Cardiovascular Mortality
Time frame: From enrollment through the 15-month follow-up period
Stroke or Systemic Embolism
Time frame: From enrollment through the 15-month follow-up period
Clinical Utility of Remote Monitoring
Time frame: At the end of the 15-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 and Cardiomyopathy, run by Samsung Medical Center at 1 site in South Korea.
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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Device-Based Sensor Parameters Associated With Heart Failure Worsening Events (time frame: From enrollment through the 15-month follow-up period). 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 7 Aug 2026.