Cardiac Rhythm DisorderNCT04559945

The LEADLESS II IDE Study for the Aveir VR Leadless Pacemaker System

A study testing Aveir VR Leadless Pacemaker System in people with Cardiac Rhythm Disorder and Bradycardia, run by Abbott Medical Devices at 53 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

prospective, non-randomized, multi-center, international clinical study is designed to confirm the safety and effectiveness of the Aveir LP System in a subject population indicated for a VVI(R) pacemaker. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiac Rhythm Disorder, Bradycardia
What is being tested?: Aveir VR Leadless Pacemaker System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,276 participants
Where: 53 sitesin 8 countries
Study dates: 13 Nov 2020to 15 Sep 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

Subject must have one of the clinical indications before device implant in adherence with Medicare, ACC/AHA/HRS/ESC single chamber pacing guidelines including:
Chronic and/or permanent atrial fibrillation with 2° or 3° AV or bifascicular bundle branch block (BBB block), including slow ventricular rates (with or without medication) associated with atrial fibrillation; or
Normal sinus rhythm with 2° or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or
Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and
Subject is ≥18 years of age; and
Subject has a life expectancy of at least one year; and

Show all 10Show fewer

Subject is not enrolled in another clinical investigation; and
Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
Subject has been informed of the nature of the study, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC; and
Subject is not pregnant and does not plan to get pregnant during the course of the study.

Who cannot join

Subject has known pacemaker syndrome, has retrograde VA conduction, or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or
Subject is allergic or hypersensitive to < 1 mg of dexamethasone sodium phosphate (DSP);
Subject has a mechanical tricuspid valve prosthesis; or
Subject has a pre-existing endocardial pacing or defibrillation leads; or
Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device; or
Subject has an implanted vena cava filter; or

Show all 10Show fewer

Subject has evidence of thrombosis in one of the veins used for access during the procedure; or
Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment; or
Subject has an implanted leadless cardiac pacemaker or
Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators).

Trial locations and contacts

53 sites in 8 countries.

Country

City, postcode or hospital

53 sites in 8 countries

United States38 sites

Piedmont Athens Regional Medical Center
Athens, Georgia, 30306
University Hospital - University of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35294
Lahey Clinic Medical Center
Burlington, Massachusetts, 01805
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ascension St. John Hospital
Detroit, Michigan, 48236
St. Elizabeth Medical Center - South Unit
Edgewood, Kentucky, 41017
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Cone Health Medical Group HeartCare
Greensboro, North Carolina, 27401
The Heart Center PC
Huntsville, Alabama, 35801
Kansas University Medical Center
Kansas City, Kansas, 66160
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
Baptist Health Lexington
Lexington, Kentucky, 40503
University of Kentucky
Lexington, Kentucky, 40536
South Denver Cardiology Associates PC
Littleton, Colorado, 80120
University of Southern California
Long Beach, California, 90803
Methodist University Hospital
Memphis, Tennessee, 38104
Naples Heart Rhythm Specialists PA
Naples, Florida, 34119
Ochsner Medical Center
New Orleans, Louisiana, 70121
New York Presbyterian Hospital/Cornell University
New York, New York, 10021
Mount Sinai Hospital
New York, New York, 10029
Premier Cardiology Inc
Newport Beach, California, 92663
Jersey Shore University Medical Center
Ocean Township, New Jersey, 07712
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Orlando Health
Orlando, Florida, 32806
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas, 66211
Huntington Memorial Hospital
Pasadena, California, 91105
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
Redmond Regional Medical Center
Rome, Georgia, 30165
Cardiac Arrhythmia & Pacemaker Center
Roslyn, New York, 11576
University of Utah Hospital
Salt Lake City, Utah, 84132
South Texas Cardiovascular Consultants
San Antonio, Texas, 78201
Honor Health
Scottsdale, Arizona, 85258
Mercy Hospital St. Louis
St Louis, Missouri, 63141
Memorial Hermann Hospital
The Woodlands, Texas, 77380
Munson Medical Center
Traverse City, Michigan, 49684
WellSpan Health
York, Pennsylvania, 17405

Other trials in United States

Canada6 sites

Foothills Medical Centre
Calgary, Alberta
Kinsgston General Hospital
Kingston, Ontario
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec
Southlake Regional Health Centre
Newmarket, Ontario
Institut de Cardiologie de Quebec (Hospital Laval)
Québec, Quebec
HSC, Eastern Health
St. John's, Newfoundland and Labrador, A1B 3V6

Other trials in Canada

France3 sites

CHRU Albert Michallon
Grenoble
Hopital d'adulte de la Timone
Marseille
CHRU Hopital de Pontchaillou
Rennes

Other trials in France

Netherlands2 sites

Amsterdam Academic Medical Centre (AMC)
Amsterdam
Isala - ZWolle
Zwolle

Other trials in Netherlands

Czechia1 site

Na Homolce Hospital
Prague, 150 30

Other trials in Czechia

Italy1 site

Centro Cardiologico Monzino
Milan

Other trials in Italy

Spain1 site

Hospital Universitario Infanta Cristina
Badajoz, 6080

Other trials in Spain

United Kingdom1 site

Royal Brompton Hospital
London

Other trials in United Kingdom

About this study

Official title: The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System

Conditions: Cardiac Rhythm Disorder, Bradycardia
Being tested: Aveir VR Leadless Pacemaker System
Keywords: Bradycardia, Pacemaker, Leadless
Medical subject headings: Arrhythmias, Cardiac, Bradycardia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aveir VR Leadless Pacemaker SystemDevice
Patients will undergo an attempted leadless pacemaker implant

Study groups in NCT04559945
Study group	Role	What they receive
Aveir VR Leadless Pacemaker	Experimental	VVIR pacing Receives: Device: Aveir VR Leadless Pacemaker System

What is being measured

The primary outcome is the main question the study is designed to answer.

Complication-Free Rate (CFR)
Complication is any device-or-procedure related serious adverse event, or serious adverse device effect, including those that prevented initial implantation. Complications possibly related or related to COVID-19 were excluded. Percentage of participants free from complications are reported
Measured: 6 weeks
Complication-Free Rate (CFR)
Complication is any device-or-procedure related serious adverse event, or serious adverse device effect, including those that prevented initial implantation. Complications possibly related or related to COVID-19 were excluded. The complication free rate reported describes the Kaplan-Meier estimate of the percentage of patients that had no complications at the given time point.
Measured: 12 months
Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range
Success Rate is percentage of subjects who have acceptable pacing threshold and sensing amplitudes, which are defined as pacing threshold <=2.0V at 0.4 ms pulse width and R-wave amplitude =>5.0 mV or => value at implant.
Measured: 6 Weeks (Aveir VR Leadless Pacemaker arm)
Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range
Success Rate is percentage of subjects who have acceptable pacing threshold and sensing amplitudes at 12-Month post-implant visit, which are defined as pacing threshold <=2.0V at 0.4 ms pulse width and R-wave amplitude =>5.0 mV or => value at implant.
Measured: 12 months

Secondary outcomes (2)

Appropriate and Proportional Rate Response During Graded Exercise Testing
Temperature-based rate response feature was evaluated to determine whether an appropriate and proportional rate response was achieved during maximal effort graded treadmill exercise testing protocol (CAEP). Subjects were asked to perform a six-minute walk test to identify optimal sensor parameters prior to conducting a CAEP test. Exercise test data provide an estimate of the slope of the normalized increase in sensor-indicated rate versus normalized workload for each subject. Normalizing a variable eliminates the unit. Since both axes are normalized, there is no unit of measure. The vertical axis is derived from the difference of the sensor indicated rate at each exercise stage and the base rate, divided by the difference of the age-predicted maximum heart rate and base rate. Values on the horizontal axis are derived from the difference in the workload at each exercise stage and resting workload, divided by the difference of the maximum achieved workload and resting workload.
Measured: 3 month follow up
Survival Rate of Patients Implanted With the Nanostim Leadless Pacemaker
All-Cause Mortality through 2 years among subjects implanted with the Nanostim Leadless Pacemaker. The Nanostim Leadless Pacemaker is functionally similar to the Aveir VR Leadless Pacemaker, and was evaluated in The LEADLESS II IDE Study (Phase I) - NCT02030418. For detailed demographic and study information including adverse events, refer to NCT02030418
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Nov 202015 Sep 2023

First posted23 Sep 2020
Study start13 Nov 2020
Primary completion18 Jul 2022
Study completion15 Sep 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 Cardiac Rhythm DisorderStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe 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: 1,276 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04559945
Sponsor's protocol ID: ABT-CIP-10355
Status last verified: Aug 2025
First submitted: 17 Sep 2020
Last updated: 20 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Rashtian MY, Ip JE, Exner DV, Reddy VY, Doshi RN, Defaye P, Canby RC, Bongiorni MG, Shoda M, Hindricks G, Nevo JR, Ligon D, Bulusu A, Knops RE. Temperature-based rate response in a leadless pacemaker system. Heart Rhythm. 2025 Jun;22(6):1533-1540. doi: 10.1016/j.hrthm.2024.11.032. Epub 2024 Nov 22.
PubMed 39581426
Reddy VY, Exner DV, Doshi R, Tomassoni G, Bunch TJ, Friedman P, Estes NAM, Neuzil P, de la Concha JF, Cantillon DJ; LEADLESS II Investigators. 1-Year Outcomes of a Leadless Ventricular Pacemaker: The LEADLESS II (Phase 2) Trial. JACC Clin Electrophysiol. 2023 Jul;9(7 Pt 2):1187-1189. doi: 10.1016/j.jacep.2023.01.031. Epub 2023 Mar 22. No abstract available.
PubMed 36951813

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Product Surveillance Registry
Cardiac Rhythm Disorders, Urological Disorders
Recruiting
BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
Leadless Pacemaker, Bradycardia
Recruiting
LEAP 2 Chronic EFS
Cardiac Pacemaker, Cardiac Rhythm Disorder
Recruiting
Optimal Settings for Anti Tachycardia Pacing (ATP) on ICD
Heart Disease, Implantable Cardioverter Defibrillator (ICD)
Enrolling by invitationObservational study
Cor360: Clinician-Facing Broad-Spectrum Cardiac Phenotyping and Risk Assessment Using COR® Wearable ECG to Inform Outcomes-Oriented Care Pathways
Cardiovascular Diseases, Cardiovascular Diseases Risk

All Cardiac Rhythm Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The LEADLESS II IDE Study (Phase II): A Safety and Effectiveness Trial for a Leadless Pacemaker System
ClinicalTrials.gov ID: NCT04559945
Acronym / sponsor ID: ABT-CIP-10355
Conditions: Cardiac Rhythm Disorder, Bradycardia
Keywords: Bradycardia, Pacemaker, Leadless
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,276 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: 13 Nov 2020 (actual)
Primary completion: 18 Jul 2022 (actual)
Study completion: 15 Sep 2023 (actual)
First posted: 23 Sep 2020 (actual)
Results: Posted 20 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Aveir VR Leadless Pacemaker	Experimental	Device: Aveir VR Leadless Pacemaker SystemVVIR pacing

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Subject must have one of the clinical indications before device implant in adherence with Medicare, ACC/AHA/HRS/ESC single chamber pacing guidelines including:
Subject is ≥18 years of age; and
Subject has a life expectancy of at least one year; and
Subject is not enrolled in another clinical investigation; and
Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and

Key exclusion criteria (10 listed)

Subject has known pacemaker syndrome, has retrograde VA conduction, or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or
Subject is allergic or hypersensitive to < 1 mg of dexamethasone sodium phosphate (DSP);
Subject has a mechanical tricuspid valve prosthesis; or
Subject has a pre-existing endocardial pacing or defibrillation leads; or
Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device; or

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
Aveir VR Leadless Pacemaker SystemPatients will undergo an attempted leadless pacemaker implant	Device	Aveir VR Leadless Pacemaker

Primary outcome

Complication-Free Rate (CFR)
Time frame: 6 weeks
Complication is any device-or-procedure related serious adverse event, or serious adverse device effect, including those that prevented initial implantation. Complications possibly related or related to COVID-19 were excluded. Percentage of participants free from complications are reported
Complication-Free Rate (CFR)
Time frame: 12 months
Complication is any device-or-procedure related serious adverse event, or serious adverse device effect, including those that prevented initial implantation. Complications possibly related or related to COVID-19 were excluded. The complication free rate reported describes the Kaplan-Meier estimate of the percentage of patients that had no complications at the given time point.
Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range
Time frame: 6 Weeks (Aveir VR Leadless Pacemaker arm)
Success Rate is percentage of subjects who have acceptable pacing threshold and sensing amplitudes, which are defined as pacing threshold <=2.0V at 0.4 ms pulse width and R-wave amplitude =>5.0 mV or => value at implant.
Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range
Time frame: 12 months
Success Rate is percentage of subjects who have acceptable pacing threshold and sensing amplitudes at 12-Month post-implant visit, which are defined as pacing threshold <=2.0V at 0.4 ms pulse width and R-wave amplitude =>5.0 mV or => value at implant.

2 secondary outcomes

Appropriate and Proportional Rate Response During Graded Exercise Testing
Time frame: 3 month follow up
Survival Rate of Patients Implanted With the Nanostim Leadless Pacemaker
Time frame: 2 years

Results and safety

Results posted to the registry on 20 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aveir VR Leadless Pacemaker	324	178

Primary outcome: Complication-Free Rate (CFR)

Time frame: 6 weeks. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Aveir VR Leadless Pacemaker n = 198
Value	96.0 (92.2 to 98.2)

Aveir VR Leadless Pacemaker: Binomial Proportion: 96.0 (95% CI 92.2 to 98.2), p <0.0001, Exact test for binomial proportion

Population analysed: First 200 Aveir VR subjects. Subjects who withdrew or died prior to the 6-week post-implant visit without a complication were excluded.

Primary outcome: Complication-Free Rate (CFR)

Time frame: 12 months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Aveir VR Leadless Pacemaker n = 210
Value	93.2 (88.7 to 95.9)

Aveir VR Leadless Pacemaker: Kaplan-Meier Survival Analysis: 93.2 (95% CI 88.7 to 95.9), p <0.0001, Z-Test

Population analysed: First 210 Aveir VR subjects within the enrolled population. Subjects who withdrew or died prior to the 12-Month post-implant visit without a complication were censored.

Primary outcome: Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range

Time frame: 6 Weeks (Aveir VR Leadless Pacemaker arm). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Aveir VR Leadless Pacemaker n = 196
Value	95.9 (92.1 to 98.2)

Aveir VR Leadless Pacemaker: Binomial Proportion: 95.9 (95% CI 92.1 to 98.2), p <0.0001, Exact test for binomial proportion

Population analysed: First 200 subjects within the enrolled Aveir VR population with a successful implant

Primary outcome: Pacing Thresholds and R-wave Amplitudes Within the Therapeutic Range

Time frame: 12 months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Aveir VR Leadless Pacemaker n = 205
Value	95.1 (91.2 to 97.6)

Aveir VR Leadless Pacemaker: Binomial Proportion: 95.1 (95% CI 91.2 to 97.6), p <0.0001, Exact test for binomial proportion

Population analysed: First 210 subjects within the enrolled Aveir VR population with a successful implant

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Aveir VR: Mean follow-up of 12.8 months post-implant (median 14.2 months), range 0 to 21.5 months post-implant Nanostim: Mean follow-up of 44.2 months post-implant (median 40.9 months). Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aveir VR Leadless Pacemaker	98 of 324 (30.2%)	60 of 324 (18.5%)	31 of 324

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39581426Rashtian MY, Ip JE, Exner DV, Reddy VY, Doshi RN, Defaye P, Canby RC, Bongiorni MG, Shoda M, Hindricks G, Nevo JR, Ligon D, Bulusu A, Knops RE. Temperature-based rate response in a leadless pacemaker system. Heart Rhythm. 2025 Jun;22(6):1533-1540. doi: 10.1016/j.hrthm.2024.11.032. Epub 2024 Nov 22.
Derived from this study: PubMed 36951813Reddy VY, Exner DV, Doshi R, Tomassoni G, Bunch TJ, Friedman P, Estes NAM, Neuzil P, de la Concha JF, Cantillon DJ; LEADLESS II Investigators. 1-Year Outcomes of a Leadless Ventricular Pacemaker: The LEADLESS II (Phase 2) Trial. JACC Clin Electrophysiol. 2023 Jul;9(7 Pt 2):1187-1189. doi: 10.1016/j.jacep.2023.01.031. Epub 2023 Mar 22. No abstract available.
Individual participant dataSharing planned: No

Related trials for Cardiac Rhythm Disorder

RecruitingObservational study
Product Surveillance Registry
Cardiac Rhythm Disorders, Urological Disorders
Recruiting
BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System
Leadless Pacemaker, Bradycardia
Recruiting
LEAP 2 Chronic EFS
Cardiac Pacemaker, Cardiac Rhythm Disorder
Recruiting
Optimal Settings for Anti Tachycardia Pacing (ATP) on ICD
Heart Disease, Implantable Cardioverter Defibrillator (ICD)
Enrolling by invitationObservational study
Cor360: Clinician-Facing Broad-Spectrum Cardiac Phenotyping and Risk Assessment Using COR® Wearable ECG to Inform Outcomes-Oriented Care Pathways
Cardiovascular Diseases, Cardiovascular Diseases Risk

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.

Nicole Harbert study director

Abbott

53 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Aveir VR Leadless Pacemaker System in people with Cardiac Rhythm Disorder and Bradycardia, run by Abbott Medical Devices at 53 sites in 8 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 10 inclusion and 10 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 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Canada, France, Netherlands, Czechia and 3 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 20 May 2026). 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?

Complication-Free Rate (CFR) (time frame: 6 weeks). 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 NCT04559945, 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 20 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.