Heart FailureCSPOTNCT04905290
Conduction System Pacing Optimized Therapy
A study testing Left ventricular coronary sinus (BiV) configuration, Conduction system pacing-only configuration and Conduction System Pacing Optimized Therapy (CSPOT) configuration in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 12 sites in 4 countries.
Trial summary
The purpose of the CSPOT study is to determine the best mode of cardiac resynchronization therapy (CRT) pacing for different populations of CRT patients, comparing traditional biventricular or left ventricular pacing (BiV), conduction system pacing (CSP)-only, and conduction system pacing optimized therapy (CSPOT)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Left ventricular coronary sinus (BiV) configuration, Conduction system pacing-only configuration and Conduction System Pacing Optimized Therapy (CSPOT) configuration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 27 Nov 2021to 2 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patient is willing and able to provide written informed consent
- Subject is at least 18 years of age
- Patient is willing and able to comply with the protocol, including follow-up visits
- The patient's medical records must be accessible by the enrolling site over the follow-up period
- Standard CRT-D or CRT-P indications, with a preference for IVCD and non-LBBB patients, where LBBB is defined according to Strauss criteria.
- De-novo CRT implant, including upgrade from pacemaker or ICD
Who cannot join
- Subject has persistent or permanent AF (Atrial Fibrillation)/AFL (Atrial Flutter)
- Subject has 2nd or 3rd degree AV (Atrioventricular) Block
- Subject has RBBB with no additional conduction block
- Subject has intrinsic (non-paced) QRS width less than or equal to 120 ms
- Subject experienced MI within 40 days prior to enrollment
- Subject underwent valve surgery, within 90 days prior to enrollment
Show all 16Show fewer
- Subject is post heart transplantation or is actively listed on the transplantation list
- Subject is implanted with a LV assist device
- Subject has severe renal disease
- Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure
- Subject has severe aortic stenosis (with a valve area of <1.0 cm or significant valve disease expected to be operated within study period)
- Subject has severe aortic calcification or severe peripheral arterial disease
- Subject has complex and uncorrected congenital heart disease
- Subject has mechanical heart valve
- Pregnant or breastfeeding woman (pregnancy test required for woman of child-bearing potential and who are not on a reliable form of birth regulation method or abstinence)
- Subject is enrolled in another study that could confound the results of this study without documented pre-approval from Medtronic study manager
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
United States7 sites
The University of Chicago Medicine
Chicago, Illinois, 60637
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Medtronic Inc
Mounds View, Minnesota, 55112
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of South Florida
Tampa, Florida, 33606
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711
Poland2 sites
Górnośląskie Centrum Medyczne im prof Leszka Gieca Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice, 40-635
Szpital Uniwersytecki w Krakowie
Krakow, 30-688
United Kingdom2 sites
Hammersmith Hospital
London, W12 0HS
Great Western Hospital
Swindon, SN3 6BB
About this study
Official title: Conduction System Pacing Optimized Therapy Study
The purpose of the CSPOT study is to determine the best mode of cardiac resynchronization therapy (CRT) pacing for different populations of CRT patients, comparing traditional biventricular or left ventricular pacing (BiV), conduction system pacing (CSP)-only, and conduction system pacing optimized therapy (CSPOT) also known as a combination of conduction system pacing (CSP) and left ventricular (LV) pacing. Additionally, safety of the system will be assessed.
- Conditions
- Heart Failure
- Being tested
- Left ventricular coronary sinus (BiV) configuration, Conduction system pacing-only configuration, Conduction System Pacing Optimized Therapy (CSPOT) configuration
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left ventricular coronary sinus (BiV) configurationDevice
For subjects with a pacemaker, pacing of the left ventricular coronary sinus only. For subjects with a defibrillator, biventricular pacing of the left ventricular coronary sinus and the right ventricle. During the acute protocol, the five AV delays for this intervention include the default AV delay setting, default + 30 milliseconds (ms) AV delay, default + 60 ms AV delay, default - 30ms AV delay, default - 60ms AV delay. Patients with a defibrillator will receive two additional delays LV precedes default by 30ms and LV precedes default by 60ms.
Conduction system pacing-only configurationDevice
Conduction System Pacing (CSP) of the left bundle branch. During the acute protocol, the five AV delays for this intervention include the default AV delay setting, default + 30 milliseconds (ms) AV delay, default + 60 ms AV delay, default - 30ms AV delay, and default - 60ms AV delay.
Conduction System Pacing Optimized Therapy (CSPOT) configurationDevice
A combination of Left Ventricle pacing and Conduction System Pacing of the left bundle branch. During the acute protocol, the eight delays for this intervention include the default AV delay setting, default + 30 milliseconds (ms) AV delay, default + 60 ms AV delay, default - 30ms AV delay, default - 60ms AV delay, CSP precedes default by 30ms, LV precedes default by 30ms and LV precedes default by 60ms.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Patients will undergo 1) Conduction System Pacing Optimized Therapy (CSPOT) lead placement, then the 2) acute pacing protocol, and then 3) device implant. During the acute pacing protocol (step 2), all patients will undergo three types of pacing configurations and for each pacing configuration several delay settings, as defined in Assigned Interventions. For each intervention, defined as a unique combination of pacing configuration and delay setting, the protocol will alternate for several heartbeats between AV pacing and intervention (5 sections of AV pacing and 4 sections of intervention). For each set of 9, Left Ventricular dP/dt max will be calculated continuously, and Standard Deviation of Activation Time will be selected from one of the sections for atrial-only pacing and one of the intervention sections. Device implant (step 3) will be with either a CRT-D or CRT-P. Each patient's device will be programmed to CSPOT pacing. Patients will be followed for 6 months. Receives: Device: Left ventricular coronary sinus (BiV) configuration; Device: Conduction system pacing-only configuration; Device: Conduction System Pacing Optimized Therapy (CSPOT) configuration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrical Synchronization Response
Standard Deviation of Activation Times (SDAT) is a measurement of dyssynchrony, taken by the ECG belt. As described in the SDAT Acute Protocol (below) and intervention sections, percent change in SDAT from AV-only pacing was calculated for each patient-pacing configuration combination over the 5 AV delays. Within each patient the difference between CSPOT SDAT and CSP SDAT and the difference between CSPOT SDAT and BiV SDAT were taken. The mean of those differences across patients was calculated along with a 95% confidence interval.
Measured: At implant during acute protocol
Hemodynamic Response
Left Ventricular (LV) dP/dt max, a measurement of the initial velocity of myocardial contraction. As described in the LV dP/dt max (below) and intervention sections, percent change in LV dP/dt max from AV-only pacing was calculated for each patient-pacing configuration combination over the 5 AV delays. Within each patient the difference between CSPOT SDAT and CSP SDAT and the difference between CSPOT SDAT and BiV SDAT were taken. The mean of those differences across patients was calculated along with a 95% confidence interval.
Measured: At implant during acute protocol
Secondary outcomes (9)
Left Ventricular Ejection Fraction (LVEF)
Left ventricular ejection fraction will be measured, based on echocardiography, at the baseline visit and again at the 6-month follow-up visit. Change will be calculated as the value observed at baseline subtracted from the value observed at 6 months.
Measured: Baseline and 6 months
Left Ventricular End Systolic Volume (LVESV)
Left ventricular end systolic volume will be measured, based on echocardiography, at the baseline visit and again at the 6-month follow-up visit. The change will be calculated as difference between the 6-month and baseline values, divided by the baseline value.
Measured: Baseline and 6 months
Clinical Composite Score (CCS)
The Clinical Composite Score (CCS) is a validated 3-level categorical variable that can take the values - Improved, Unchanged, or Worsened - at each follow-up visit. It is based on mortality, HF events, termination of device function, NYHA score, and patient global assessment. Briefly, the scoring system is as follows:
- A patient is considered "worsened" if they die, demonstrate a worsened NYHA class, report at least moderately worsened heart-failure symptoms, or are hospitalized or permanently discontinue therapy because of or associated with worsening heart-failure
- A patient is considered "improved" if they have not "worsened" and either demonstrate improvement in NYHA class or report at least moderately improved heart-failure symptoms
- A patient is considered "stabilized" if they have not "worsened" or "improved"
- A patient is considered "unavailable" if they did not complete 6-month visit and was not "worsened"
Measured: 6 months
Absolute Percent Change in SDAT by QRS Subgroup
Percent change in SDAT (as described in Primary Outcome 1: Arm/Group Description) by baseline QRS subgroup for each pacing configuration CSP, BiV, CSPOT during acute protocol at implant.
The QRS subgroups were subjects with QRS width greater than 171ms and QRS width less than or equal to 171ms as measured by 12-lead ECG
Measured: At Implant during acute protocol
Absolute Percent Change in SDAT Split by Subjects With Pure LBBB and With Other Conduction Disorders
Percent change in SDAT (as described in Primary Outcome 1: Arm/Group Description) split by subjects with pure Left Bundle Branch Block (LBBB) and with other Conduction Disorders for each pacing configuration CSP, BiV and CSPOT during acute protocol.
Measured: At Implant during acute protocol
Absolute Percent Change in SDAT Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy
Absolute Percent change in SDAT (as described in Primary Outcome 1: Arm/Group Description) split by subjects with Ischemic Cardiomyopathy and those with Non-Ischemic Cardiomyopathy for each pacing configuration CSP, BiV and CSPOT during acute protocol.
Measured: At Implant during acute protocol
Percent Change in LV dP/dt Max Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy
Percent change in LV dP/dt max (as described in Primary Outcome 2: Arm/Group Description)split by subjects with Ischemic Cardiomyopathy and those with Non-Ischemic Cardiomyopathy for each pacing configuration CSP, BiV and CSPOT during acute protocol.
Measured: At Implant during acute protocol
Percent Change in LV dP/dt Max Split by Subjects With Pure Left Bundle Branch Block (LBBB) and With Other Conduction Disorders (NIVCD)
Percent change in LV dP/dt max (as described in Primary Outcome 2: Arm/Group Description) split by subjects with pure Left Bundle Branch Block (LBBB) and with other Conduction Disorders (NIVCD) for each pacing configuration CSP, BiV and CSPOT during acute protocol
Measured: At Implant during acute protocol
Improvement in LV dP/dt Max by QRS Subgroup
Percent change in LV dP/dt max (as described in Primary Outcome 2: Arm/Group Description) by QRS subgroup for each pacing configuration CSP, BiV and CSPOT during acute protocol. The QRS subgroups were subjects with QRS width greater than 171ms and QRS width less than or equal to 171ms as measured by 12-lead ECG
Measured: At Implant during acute protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start27 Nov 2021
- Primary completion18 Apr 2023
- Study completion2 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905290
- Sponsor's protocol ID
- MDT20029
- Acronym
- CSPOT
- Status last verified
- Oct 2023
- First submitted
- 24 May 2021
- Last updated
- 15 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Schaller RD, Foley P, Chandrasekaran B, Lyne J, Jastrzebski M, Vijayaraman P, Upadhyay GA, Gardas R, Richardson T, Kudlik D, Stadler RW, Zimmerman P, Burrell J, Waxman R, Cornelussen RN, Herweg B, Whinnett Z. Optimal pace timing for left bundle branch area pacing with or without an additional LV lead: results from the CSPOT study. Europace. 2026 May 6;28(5):euag103. doi: 10.1093/europace/euag103.
PubMed 42085561Jastrzebski M, Foley P, Chandrasekaran B, Whinnett Z, Vijayaraman P, Upadhyay GA, Schaller RD, Gardas R, Richardson T, Kudlik D, Stadler RW, Zimmerman P, Burrell J, Waxman R, Cornelussen RN, Lyne J, Herweg B. Multicenter Hemodynamic Assessment of the LOT-CRT Strategy: When Does Combining Left Bundle Branch Pacing and Coronary Venous Pacing Enhance Resynchronization?: Primary Results of the CSPOT Study. Circ Arrhythm Electrophysiol. 2024 Nov;17(11):e013059. doi: 10.1161/CIRCEP.124.013059. Epub 2024 Oct 23.
PubMed 39440428
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conduction System Pacing Optimized Therapy Study
- ClinicalTrials.gov ID
- NCT04905290
- Acronym / sponsor ID
- CSPOT / MDT20029
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2021 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Posted 17 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the CSPOT study is to determine the best mode of cardiac resynchronization therapy (CRT) pacing for different populations of CRT patients, comparing traditional biventricular or left ventricular pacing (BiV), conduction system pacing (CSP)-only, and conduction system pacing optimized therapy (CSPOT) also known as a combination of conduction system pacing (CSP) and left ventricular (LV) pacing. Additionally, safety of the system will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: Left ventricular coronary sinus (BiV) configuration, Device: Conduction system pacing-only configuration, Device: Conduction System Pacing Optimized Therapy (CSPOT) configurationPatients will undergo 1) Conduction System Pacing Optimized Therapy (CSPOT) lead placement, then the 2) acute pacing protocol, and then 3) device implant. During the acute pacing protocol (step 2), all patients will undergo three types of pacing configurations and for each pacing configuration several delay settings, as defined in Assigned Interventions. For each intervention, defined as a unique combination of pacing configuration and delay setting, the protocol will alternate for several heartbeats between AV pacing and intervention (5 sections of AV pacing and 4 sections of intervention). For each set of 9, Left Ventricular dP/dt max will be calculated continuously, and Standard Deviation of Activation Time will be selected from one of the sections for atrial-only pacing and one of the intervention sections. Device implant (step 3) will be with either a CRT-D or CRT-P. Each patient's device will be programmed to CSPOT pacing. Patients will be followed for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is willing and able to provide written informed consent
- Subject is at least 18 years of age
- Patient is willing and able to comply with the protocol, including follow-up visits
- The patient's medical records must be accessible by the enrolling site over the follow-up period
- Standard CRT-D or CRT-P indications, with a preference for IVCD and non-LBBB patients, where LBBB is defined according to Strauss criteria.
Key exclusion criteria (16 listed)
- Subject has persistent or permanent AF (Atrial Fibrillation)/AFL (Atrial Flutter)
- Subject has 2nd or 3rd degree AV (Atrioventricular) Block
- Subject has RBBB with no additional conduction block
- Subject has intrinsic (non-paced) QRS width less than or equal to 120 ms
- Subject experienced MI within 40 days prior to enrollment
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 |
|---|---|---|
| Left ventricular coronary sinus (BiV) configurationFor subjects with a pacemaker, pacing of the left ventricular coronary sinus only. For subjects with a defibrillator, biventricular pacing of the left ventricular coronary sinus and the right ventricle. During the acute protocol, the five AV delays for this intervention include the default AV delay setting, default + 30 milliseconds (ms) AV delay, default + 60 ms AV delay, default - 30ms AV delay, default - 60ms AV delay. Patients with a defibrillator will receive two additional delays LV precedes default by 30ms and LV precedes default by 60ms. | Device | Single Arm |
| Conduction system pacing-only configurationConduction System Pacing (CSP) of the left bundle branch. During the acute protocol, the five AV delays for this intervention include the default AV delay setting, default + 30 milliseconds (ms) AV delay, default + 60 ms AV delay, default - 30ms AV delay, and default - 60ms AV delay. | Device | Single Arm |
| Conduction System Pacing Optimized Therapy (CSPOT) configurationA combination of Left Ventricle pacing and Conduction System Pacing of the left bundle branch. During the acute protocol, the eight delays for this intervention include the default AV delay setting, default + 30 milliseconds (ms) AV delay, default + 60 ms AV delay, default - 30ms AV delay, default - 60ms AV delay, CSP precedes default by 30ms, LV precedes default by 30ms and LV precedes default by 60ms. | Device | Single Arm |
Primary outcome
Electrical Synchronization Response
Time frame: At implant during acute protocol
Standard Deviation of Activation Times (SDAT) is a measurement of dyssynchrony, taken by the ECG belt. As described in the SDAT Acute Protocol (below) and intervention sections, percent change in SDAT from AV-only pacing was calculated for each patient-pacing configuration combination over the 5 AV delays. Within each patient the difference between CSPOT SDAT and CSP SDAT and the difference between CSPOT SDAT and BiV SDAT were taken. The mean of those differences across patients was calculated along with a 95% confidence interval.
Hemodynamic Response
Time frame: At implant during acute protocol
Left Ventricular (LV) dP/dt max, a measurement of the initial velocity of myocardial contraction. As described in the LV dP/dt max (below) and intervention sections, percent change in LV dP/dt max from AV-only pacing was calculated for each patient-pacing configuration combination over the 5 AV delays. Within each patient the difference between CSPOT SDAT and CSP SDAT and the difference between CSPOT SDAT and BiV SDAT were taken. The mean of those differences across patients was calculated along with a 95% confidence interval.
9 secondary outcomes
Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline and 6 months
Left Ventricular End Systolic Volume (LVESV)
Time frame: Baseline and 6 months
Clinical Composite Score (CCS)
Time frame: 6 months
Absolute Percent Change in SDAT by QRS Subgroup
Time frame: At Implant during acute protocol
Absolute Percent Change in SDAT Split by Subjects With Pure LBBB and With Other Conduction Disorders
Time frame: At Implant during acute protocol
Absolute Percent Change in SDAT Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy
Time frame: At Implant during acute protocol
Percent Change in LV dP/dt Max Split by Subjects With Ischemic Cardiomyopathy and Those With Non-Ischemic Cardiomyopathy
Time frame: At Implant during acute protocol
Percent Change in LV dP/dt Max Split by Subjects With Pure Left Bundle Branch Block (LBBB) and With Other Conduction Disorders (NIVCD)
Time frame: At Implant during acute protocol
Improvement in LV dP/dt Max by QRS Subgroup
Time frame: At Implant during acute protocol
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42085561Schaller RD, Foley P, Chandrasekaran B, Lyne J, Jastrzebski M, Vijayaraman P, Upadhyay GA, Gardas R, Richardson T, Kudlik D, Stadler RW, Zimmerman P, Burrell J, Waxman R, Cornelussen RN, Herweg B, Whinnett Z. Optimal pace timing for left bundle branch area pacing with or without an additional LV lead: results from the CSPOT study. Europace. 2026 May 6;28(5):euag103. doi: 10.1093/europace/euag103.
- Derived from this study: PubMed 39440428Jastrzebski M, Foley P, Chandrasekaran B, Whinnett Z, Vijayaraman P, Upadhyay GA, Schaller RD, Gardas R, Richardson T, Kudlik D, Stadler RW, Zimmerman P, Burrell J, Waxman R, Cornelussen RN, Lyne J, Herweg B. Multicenter Hemodynamic Assessment of the LOT-CRT Strategy: When Does Combining Left Bundle Branch Pacing and Coronary Venous Pacing Enhance Resynchronization?: Primary Results of the CSPOT Study. Circ Arrhythm Electrophysiol. 2024 Nov;17(11):e013059. doi: 10.1161/CIRCEP.124.013059. Epub 2024 Oct 23.
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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.
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left ventricular coronary sinus (BiV) configuration, Conduction system pacing-only configuration and Conduction System Pacing Optimized Therapy (CSPOT) configuration in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 12 sites in 4 countries.
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 6 inclusion and 16 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 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Poland, United Kingdom, Ireland. 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?
Yes. Results are posted in the registry (first posted 17 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Electrical Synchronization Response (time frame: At implant during acute protocol). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04905290, which also lists 2 linked publications.
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 15 Apr 2025; AzTrials last refreshed its copy on 27 Oct 2026.