Tachycardia, VentricularMODULAR ATPNCT04798768
Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing
A study testing mCRM Therapy System in people with Tachycardia, Ventricular and Arrhythmia, Ventricular, run by Boston Scientific Corporation at 38 sites in 9 countries.
Trial summary
The MODULAR ATP Clinical Study is designed to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia, Ventricular, Arrhythmia, Ventricular
- What is being tested?
- mCRM Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 38 sitesin 9 countries
- Study dates
- 20 Jul 2021to 31 Dec 2030
- 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 who meets Class I, IIa, or IIb guideline ICD indications[i],[ii], or who has an existing TV-ICD[iii] or S-ICD[iv]
- Patient who is deemed to be at risk for MVT based on at least ONE of the following:
- History of Non-Sustained MVT with LVEF ≤ 50%
- History of sustained VT/VF (secondary prevention) with LVEF ≤ 50% or significant cardiac scar*
- History of syncope deemed to be arrhythmic in origin
- History of ischemic cardiomyopathy with LVEF ≤35%
Show all 9Show fewer
- History of non-ischemic cardiomyopathy with LVEF ≤35% and significant scar*
- Patient who is willing and capable of providing informed consent (which is not to include the use of a legally authorized representative (LAR) for documentation of informed consent) and participating in all testing associated with this investigation at an approved study site and at the intervals defined by this protocol
- Patient who is age 18 years or above, or of legal age to give informed consent specific to state and national law
Who cannot join
- Patient with an ongoing complication due to Cardiac Implantable Electronic Device (CIED) infection or CIED explant
- Transvenous lead remnants within the heart from a previously implanted CIED (Note: transvenous lead remnants outside the heart (e.g., in the SVC) are allowed)
- Patient with a known LA thrombus
- Patient with a ventricular arrhythmia due to a reversible cause
- Patient indicated for implantation of a dual chamber pacemaker or cardiac resynchronization therapy (CRT)
- Patient with another implanted medical device that could interfere with implant of the leadless pacemaker, such as an implanted inferior vena cava filter or mechanical tricuspid heart valve
Show all 24Show fewer
- Patient requires rate-responsive pacing therapy
- Patient is entirely pacemaker-dependent (defined as escape rhythm ≤ 30 bpm)
- Patient with Acute Coronary Syndrome (i.e. Acute Myocardial Infarction, Unstable Angina) within 40 days
- Inability to access femoral vein with a 21-French or larger inner diameter introducer sheath due to known anatomy condition, recent surgery, and/ or other relevant condition
- Patient who has an active implanted electronic medical device intended for chronic use concomitantly with the study system, such as a left ventricular assist device (LVAD). Note that a temporary pacing wire is allowed.
- Patient with known or suspected sensitivity to Dexamethasone Acetate (DXA)
- Patient with a known cardiovascular anatomy that precludes implant in the right ventricle
- Patient with a known allergy to any system components
- Patient with a known or suspected intolerance to S-ICD conversion testing, based on physician discretion
- Patient is not likely to have meaningful survival** for at least 12 months (documented or per investigator's discretion)
- Patient is enrolled in any other concurrent study. Co-enrollment into other studies such as observational studies/ registries needs prior written approval by BSC. Local mandatory governmental registries are accepted for co-enrollment without approval by BSC.
- Patient who is a woman of childbearing potential who is known to be pregnant at the time of study enrollment (method of assessment upon investigator's discretion)
- [i]Al-Khatib, et al. 2017 AHA/ACC/HRS Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death. A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. (2018); 138:e272-e391.
- [ii] 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC). European Heart Journal (2015) 36, 2793-2867.
- [iii] TV-ICD system is expected to be fully explanted during or prior to full Coordinated System implant
- [iv] Potential subjects with a Model 1010 S-ICD Pulse Generator are only eligible for MODULAR ATP if they are getting upgraded to Model A209, A219 or future BSC S-ICD Pulse Generator; Patients with an existing S-ICD PG subject to the electrical overstress field action are only eligible for MODULAR ATP if they are getting a new BSC Model A209 or A219, or future BSC S-ICD Pulse Generator
- Significant cardiac scar is defined as a scar involving at least one ventricular myocardial segment (i.e., basal infero-septum) as identified in the official findings of a cMRI, or nuclear viability study, or echo report by the interpreting radiologist/ cardiologist who is not affiliated with the study
- meaningful survival means that a patient has a reasonable quality of life and functional status
Trial locations and contacts
38 sites in 9 countries.
38 sites in 9 countries
United States18 sites
Emory University Hospital
Atlanta, Georgia, 30308
Cooper Hospital - University Medical Center
Camden, New Jersey, 08103
Erlanger Medical Center
Chattanooga, Tennessee, 37403
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University Medical Center
Columbus, Ohio, 43210
Ohio Health Research Institute
Columbus, Ohio, 43214
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
Baptist Health Lexington
Lexington, Kentucky, 40503
Northwell University Hospital
Manhasset, New York, 11030
Mount Sinai Medical Center
New York, New York, 10029
Sentara Norfolk General
Norfolk, Virginia, 23507
AdventHealth Orlando
Orlando, Florida, 32803
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
Mayo Clinic
Rochester, Minnesota, 55905
Scottsdale Healthcare - Shea
Scottsdale, Arizona, 84258
University of Washington Medical Center
Seattle, Washington, 98195
France4 sites
CHU Grenoble - Hospital Michallon
Grenoble
CHRU de Lille
Lille, 59000
CHU de Nantes-Hopital Laennec
Nantes
Hospital European Georges-Pompidou
Paris
Italy4 sites
Spedali Civil di Brescia
Brescia
Maria Cecilia Hospital SPA
Cotignola
AZ Osp Monaldi
Naples, 80131
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
United Kingdom4 sites
The General Infirmary
Leeds, LS1 EX
Liverpool Heart and Chest Hospital
Liverpool, L14 3PE
Manchester Heart Center
Manchester, M13 9WL
Southampton University Hospital
Southampton
Netherlands3 sites
Amsterdam University Medical Center
Amsterdam
St. Antonius Ziekenhuis
Nieuwegein
Erasmus MC University Medical Center
Rotterdam, 3015 CE
Canada2 sites
Institut de Cardiologie de Quebec (Montreal Heart)
Montreal, Quebec, H1T 1C8
Institut Universitaire de Cardilogie et Pnuemologie de Quebec (IUCPQ)
Québec
About this study
The MODULAR ATP Clinical Study is designed to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System.
Read the detailed description
The MODULAR ATP Clinical Study will enroll subjects with a standard Implantable Cardioverter Defibrillator (ICD) indication applying international practice guidelines, as well as those who already have an implanted S-ICD System and satisfy the inclusion criteria for this study, while not meeting any exclusion criteria. Subjects will be followed for at least 6 months following mCRM Therapy System implantation.
- Conditions
- Tachycardia, Ventricular, Arrhythmia, Ventricular
- Being tested
- mCRM Therapy System
- Medical subject headings
- Tachycardia, Ventricular, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mCRM Therapy SystemDevice
Also called Communication of S-ICD to Leadless Cardiac Pacemaker (LCP)
Communication testing between S-ICD and LCP in 4 body postures as well as required electrical testing.
| Study group | Role | What they receive |
|---|---|---|
| MODULAR ATP Study Participants | Experimental | All subjects that signed the informed consent were included.
Patients consented to receive the mCRM Therapy System which consists of the EMPOWER Leadless Pacemaker and an EMBLEM S-ICD upgraded with investigational firmware. Receives: Device: mCRM Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint 1: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 6 Months
Major EMPOWER MPS System- and Procedure-related Complication-Free Rate Subjects will be assessed for safety issues related to the procedure or system through 6 months post implant
Measured: Implant through 6 Months Post-Implant
Safety Endpoint 2: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 12 Months
Major EMPOWER MPS System- and Procedure-related Complication-free Rate
Subjects will be assessed for safety issues related to the procedure or system through 12 months post implant
Measured: Implant through 12 Months Post-Implant
Primary Effectiveness Endpoint 1: Percentage of Body Postures With Communication Success Between the S-ICD and EMPOWER PG
Communication Success between the S-ICD and EMPOWER PG
Data from subjects will be assessed for effectiveness of communication between S-ICD and the EMPOWER PG by evaluating if a paced beat is present during communication testing in four postures: upright, supine, and right and left side.
Measured: At the 6 Month Follow-up
Primary Effectiveness Endpoint 2: Percentage of Subjects Classified as a Pacing Capture Threshold (PCT) Responder
Proportion of Subjects with Adequate Pacing Capture Threshold
Effectiveness will be confirmed by evaluating the percentage of subjects considered to be a PCT Responder, defined as a subject with a PCT measurement of ≤ 2.0 V @ 0.4 ms pulse width
Measured: At the 6 Month Follow-up
Secondary outcomes (2)
Secondary Effectiveness Endpoint: Subject-specific Slope of EMPOWER PG Sensor-Indicated Rate to the Subject's Workload on Treadmill Test
Metabolic-Chronotropic Relation Slope (MCR Slope) from the Kay-Wilkoff Model
Using the Kay-Wilkoff model, data will be assessed to evaluate the proportionality of the EMPOWER PG's sensor-indicated rate to the subject's workload during the treadmill test
Measured: At the 3 Month Visit
Secondary Safety Endpoint
All-Cause Survival; data not reported as it is still being collected
Measured: Implant through 2 years post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start20 Jul 2021
- Primary completion6 May 2024
- Study completion31 Dec 2030 (estimated)
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 (3)Papers the sponsor has linked to this study.
- Other trials for Tachycardia, VentricularStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Lloyd, MD, Principal investigator, Emory UniversityReinoud Knops, MD, PhD, Principal investigator, Amsterdam University Medical CentreLluis Mont, MD, PhD, Principal investigator, Hospital Clinic, University of BarcelonaVivek Reddy, MD, Principal investigator, The Mount Sinai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798768
- Sponsor's protocol ID
- C1907
- Acronym
- MODULAR ATP
- Status last verified
- Oct 2026
- First submitted
- 8 Mar 2021
- Last updated
- 15 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share IPD with other researchers in this study.
Publications
Lloyd MS, Brisben AJ, Reddy VY, Blomstrom-Lundqvist C, Boersma LVA, Bongiorni MG, Burke MC, Cantillon DJ, Doshi R, Friedman PA, Gras D, Kutalek SP, Neuzil P, Roberts PR, Wright DJ, Appl U, West J, Carter N, Stein KM, Mont L, Knops RE. Design and rationale of the MODULAR ATP global clinical trial: A novel intercommunicative leadless pacing system and the subcutaneous implantable cardioverter-defibrillator. Heart Rhythm O2. 2023 Jun 2;4(7):448-456. doi: 10.1016/j.hroo.2023.05.004. eCollection 2023 Jul.
PubMed 37520021Knops RE, Lloyd MS, Roberts PR, Wright DJ, Boersma LVA, Doshi R, Friedman PA, Neuzil P, Blomstrom-Lundqvist C, Bongiorni MG, Burke MC, Gras D, Kutalek SP, Amin AK, Fu EY, Epstein LM, Tolosana JM, Callahan TD, Aasbo JD, Augostini R, Manyam H, Nair DG, Mondesert B, Su WW, Pepper C, Miller MA, Grammes J, Saleh K, Marquie C, Merchant FM, Cha YM, Cunnington C, Frankel DS, West J, Matznick E, Swackhamer B, Brisben AJ, Weinstock J, Stein KM, Reddy VY, Mont L; MODULAR ATP Investigators. A Modular Communicative Leadless Pacing-Defibrillator System. N Engl J Med. 2024 Oct 17;391(15):1402-1412. doi: 10.1056/NEJMoa2401807. Epub 2024 May 18.
PubMed 38767244Lloyd MS, Reddy VY, Roberts P, Doshi RN, Wright DL, Boersma LVA, Friedman PA, Neuzil P, Blomstrom-Lundqvist C, Bongiorni MG, Burke MC, Gras D, Kutalek SP, Marijon E, Tolosana JM, Amin AK, Epstein LM, Aasbo JD, Callahan TD, Brisben AJ, West J, Matznick E, Speakman B, Bachman TN, Mont L, Knops RE. One-Year Outcomes of the MODULAR ATP Trial: A Novel Leadless Pacemaker in Wireless Communication With a Subcutaneous Implantable Cardioverter Defibrillator. Circ Arrhythm Electrophysiol. 2026 Jan;19(1):e014395. doi: 10.1161/CIRCEP.125.014395. Epub 2025 Nov 13.
PubMed 41231774
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing
- ClinicalTrials.gov ID
- NCT04798768
- Acronym / sponsor ID
- MODULAR ATP / C1907
- Conditions
- Tachycardia, Ventricular, Arrhythmia, Ventricular
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 15 Mar 2021 (actual)
- Results
- Posted 26 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The MODULAR ATP Clinical Study is designed to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System.
Detailed description
The MODULAR ATP Clinical Study will enroll subjects with a standard Implantable Cardioverter Defibrillator (ICD) indication applying international practice guidelines, as well as those who already have an implanted S-ICD System and satisfy the inclusion criteria for this study, while not meeting any exclusion criteria. Subjects will be followed for at least 6 months following mCRM Therapy System implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MODULAR ATP Study Participants | Experimental | Device: mCRM Therapy SystemAll subjects that signed the informed consent were included. Patients consented to receive the mCRM Therapy System which consists of the EMPOWER Leadless Pacemaker and an EMBLEM S-ICD upgraded with investigational firmware. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient who meets Class I, IIa, or IIb guideline ICD indications[i],[ii], or who has an existing TV-ICD[iii] or S-ICD[iv]
- Patient who is deemed to be at risk for MVT based on at least ONE of the following:
- Patient who is willing and capable of providing informed consent (which is not to include the use of a legally authorized representative (LAR) for documentation of informed consent) and participating in all testing associated with this investigation at an approved study site and at the intervals defined by this protocol
- Patient who is age 18 years or above, or of legal age to give informed consent specific to state and national law
Key exclusion criteria (24 listed)
- Patient with an ongoing complication due to Cardiac Implantable Electronic Device (CIED) infection or CIED explant
- Transvenous lead remnants within the heart from a previously implanted CIED (Note: transvenous lead remnants outside the heart (e.g., in the SVC) are allowed)
- Patient with a known LA thrombus
- Patient with a ventricular arrhythmia due to a reversible cause
- Patient indicated for implantation of a dual chamber pacemaker or cardiac resynchronization therapy (CRT)
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 |
|---|---|---|
| mCRM Therapy SystemAlso: Communication of S-ICD to Leadless Cardiac Pacemaker (LCP)Communication testing between S-ICD and LCP in 4 body postures as well as required electrical testing. | Device | MODULAR ATP Study Participants |
Primary outcome
Safety Endpoint 1: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 6 Months
Time frame: Implant through 6 Months Post-Implant
Major EMPOWER MPS System- and Procedure-related Complication-Free Rate Subjects will be assessed for safety issues related to the procedure or system through 6 months post implant
Safety Endpoint 2: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 12 Months
Time frame: Implant through 12 Months Post-Implant
Major EMPOWER MPS System- and Procedure-related Complication-free Rate Subjects will be assessed for safety issues related to the procedure or system through 12 months post implant
Primary Effectiveness Endpoint 1: Percentage of Body Postures With Communication Success Between the S-ICD and EMPOWER PG
Time frame: At the 6 Month Follow-up
Communication Success between the S-ICD and EMPOWER PG Data from subjects will be assessed for effectiveness of communication between S-ICD and the EMPOWER PG by evaluating if a paced beat is present during communication testing in four postures: upright, supine, and right and left side.
Primary Effectiveness Endpoint 2: Percentage of Subjects Classified as a Pacing Capture Threshold (PCT) Responder
Time frame: At the 6 Month Follow-up
Proportion of Subjects with Adequate Pacing Capture Threshold Effectiveness will be confirmed by evaluating the percentage of subjects considered to be a PCT Responder, defined as a subject with a PCT measurement of ≤ 2.0 V @ 0.4 ms pulse width
2 secondary outcomes
Secondary Effectiveness Endpoint: Subject-specific Slope of EMPOWER PG Sensor-Indicated Rate to the Subject's Workload on Treadmill Test
Time frame: At the 3 Month Visit
Secondary Safety Endpoint
Time frame: Implant through 2 years post-implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37520021Lloyd MS, Brisben AJ, Reddy VY, Blomstrom-Lundqvist C, Boersma LVA, Bongiorni MG, Burke MC, Cantillon DJ, Doshi R, Friedman PA, Gras D, Kutalek SP, Neuzil P, Roberts PR, Wright DJ, Appl U, West J, Carter N, Stein KM, Mont L, Knops RE. Design and rationale of the MODULAR ATP global clinical trial: A novel intercommunicative leadless pacing system and the subcutaneous implantable cardioverter-defibrillator. Heart Rhythm O2. 2023 Jun 2;4(7):448-456. doi: 10.1016/j.hroo.2023.05.004. eCollection 2023 Jul.
- Results publication: PubMed 38767244Knops RE, Lloyd MS, Roberts PR, Wright DJ, Boersma LVA, Doshi R, Friedman PA, Neuzil P, Blomstrom-Lundqvist C, Bongiorni MG, Burke MC, Gras D, Kutalek SP, Amin AK, Fu EY, Epstein LM, Tolosana JM, Callahan TD, Aasbo JD, Augostini R, Manyam H, Nair DG, Mondesert B, Su WW, Pepper C, Miller MA, Grammes J, Saleh K, Marquie C, Merchant FM, Cha YM, Cunnington C, Frankel DS, West J, Matznick E, Swackhamer B, Brisben AJ, Weinstock J, Stein KM, Reddy VY, Mont L; MODULAR ATP Investigators. A Modular Communicative Leadless Pacing-Defibrillator System. N Engl J Med. 2024 Oct 17;391(15):1402-1412. doi: 10.1056/NEJMoa2401807. Epub 2024 May 18.
- Derived from this study: PubMed 41231774Lloyd MS, Reddy VY, Roberts P, Doshi RN, Wright DL, Boersma LVA, Friedman PA, Neuzil P, Blomstrom-Lundqvist C, Bongiorni MG, Burke MC, Gras D, Kutalek SP, Marijon E, Tolosana JM, Amin AK, Epstein LM, Aasbo JD, Callahan TD, Brisben AJ, West J, Matznick E, Speakman B, Bachman TN, Mont L, Knops RE. One-Year Outcomes of the MODULAR ATP Trial: A Novel Leadless Pacemaker in Wireless Communication With a Subcutaneous Implantable Cardioverter Defibrillator. Circ Arrhythm Electrophysiol. 2026 Jan;19(1):e014395. doi: 10.1161/CIRCEP.125.014395. Epub 2025 Nov 13.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers in this study.
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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.
Michael Lloyd, MD principal investigator
Emory University
Reinoud Knops, MD, PhD principal investigator
Amsterdam University Medical Centre
Lluis Mont, MD, PhD principal investigator
Hospital Clinic, University of Barcelona
38 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mCRM Therapy System in people with Tachycardia, Ventricular and Arrhythmia, Ventricular, run by Boston Scientific Corporation at 38 sites in 9 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 9 inclusion and 24 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 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, France, Italy, United Kingdom, Netherlands and 4 more countries. 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 26 Jun 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?
Safety Endpoint 1: Percentage of Subjects Without Major EMPOWER MPS System- or Procedure-Related Complications Through 6 Months (time frame: Implant through 6 Months Post-Implant). The study lists 4 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 NCT04798768, which also lists 3 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 Oct 2026.