PacemakerNCT06587672
Factors Affecting Selection of Leadless Pacemaker and Atrioventricular Synchronous Pacing Status
An observational study of Pacemaker and Atrioventricular Block, run by Xiaohan Fan at 2 sites in China.
Trial summary
This is a multicenter, prospective, observational study ,the aim of this study is to find factors affecting selection of double-chamber leadless pacemaker in patients with atrioventricular block and ambulatory atrioventricular synchronous pacing status over time using a leadless ventricular pacemaker. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker, Atrioventricular Block, Clinical Trials
- What is being tested?
- Micra AV implantation
- Type of treatment
- Medical device
- How many people
- 112 participants
- Where
- 2 sitesChina
- Study dates
- 15 Sep 2024to 31 Jul 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with atrioventricular conduction block, meeting the indications for dual-chamber leadless pacemakers as per the "Chinese Expert Consensus on Clinical Application of Leadless Pacemakers (2022)".All patients should sign written informed consent for agreement of the implantation procedure.
Who may be able to join
- Patients diagnosed with atrioventricular conduction block, meeting the indications for dual-chamber leadless pacemakers as per the "Chinese Expert Consensus on Clinical Application of Leadless Pacemakers (2022)".
- Age ≥18 years.
- Expected lifespan ≥1 year.
- Consent to sign an informed consent form and cooperate in the collection of baseline data and subsequent follow-ups
Who cannot join
- Patients anticipated to have a high ventricular pacing proportion (>40%) and with left ventricular ejection fraction less than 50%.
- Patients with persistent atrial fibrillation and a high expected ventricular pacing proportion.
- Post-tricuspid valve mechanical valve replacement surgery.
- Patients with inferior vena cava pathway anomalies, precluding passage of the leadless pacemaker's delivery sheath.
- Patients with an expected lifespan of less than 1 year. 6 Patients who are pregnant, planning pregnancy, or undergoing cardiac transplantation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Fu Wai Hospital
Beijing, Beijing Municipality, 100037
Peking University First Hospital
Beijing, Beijing Municipality, 100037
About this study
Official title: Factors Affecting Selection of Leadless Pacemaker in Patients With Atrioventricular Block and Atrioventricular Synchronous Pacing Status With a Micra AV: a Multicenter, Prospective, Observational Study
This is a multicenter, prospective, observational study ,the aim of this study is to find factors affecting selection of double-chamber leadless pacemaker in patients with atrioventricular block and ambulatory atrioventricular synchronous pacing status over time using a leadless ventricular pacemaker.
Read the detailed description
Traditional pacemakers consist of a pulse generator and leads. Infections of the pulse generator pocket and lead-related complications are unavoidable issues in the application oftraditional pacemakers.Leadless pacemakers have emerged to address complications associated with the pacemaker pocket and leads in specific patients.The initial design of leadless pacemakers focused on single-chamber (right ventricular)sensing and pacing,However, patients with sinus rhythm may experience pacemakersyndrome symptoms due to atrioventricular desynchrony. Furthermore, a high proportion of atrioventricular dyssynchronous ventricular pacing might increase hospitalization rates for atrial fibrillation and heart failure.Recent developments in leadless dual-chamber pacemakersutilize a built-in triaxial accelerometer.This study aims to investigate factors considered by patients with atrioventricular block and clinical pacemaker implanting physicians when make sure the use of Micra AV. 2). It also seeks to evaluate the atrioventricular synchrony of Micra AV pacing in patients during both exercise and rest, while analyzing factors that influence the AV synchrony.For all screened patients, a questionnaire is required to be finished with data including age, gender, occupation, educational level, clinical history, comorbidities, previous infections, history of implanted electronic devices, economic status, and medical insurance conditions. At same time, all physicians are asked to complete a questionnaire for analyzing the factors influencing the decision of device option.An ambulatory electrocardiogram will be performed at 3 months, 6 months, and 1 year follow-up after device implantation. Data regarding the proportion of atrioventricular Research Protocol Template (Observational Study)_V1.0_2023.10.04 7/10 synchrony, atrial sensing atrial contraction mechanical wave (A4) threshold, ventricular pacing threshold, sensing, and impedance will be tested and collected. Postoperative exercise related symptoms and adverse events will be routinely tracked.
- Conditions
- Pacemaker, Atrioventricular Block, Clinical Trials, Pacing
- Being tested
- Micra AV implantation
- Keywords
- Leadless pacing, Atrioventricular synchrony, Atrioventricular block, Atrial contraction
- Medical subject headings
- Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micra AV implantationDevice
Patients received Micra AV implantation
| Study group | Role | What they receive |
|---|---|---|
| Patients received Micra AV implantation | Patients received Micra AV implantation Receives: Device: Micra AV implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete the survey questionnair before implanting a pacemaker
Complete the survey questionnair
Measured: 1 day before implanting a pacemaker
The percentage of atrioventricular synchrony at 3 months after Micra AV implantation.
The percentage of atrioventricular synchrony will be calculated based on the recording of a 20-minute resting period in the outpatient consulting room, via dividing the total number of AV synchronous cycles by the total number of cardiac cycles recoded by a Holter. An AV synchronous cycle will be defined as a paced or sensed ventricular beat within 300 ms following a surface ECG confirmed P-wave.
Measured: 3 months post-implant
Secondary outcomes (14)
Immediate success rate of Micra AV implantation.
Successfully implant a Micra AV during procedure.
Measured: During implantation on day 0
The percentage of atrioventricular synchrony at 6, 12 months after Micra AV implantation.
The percentage of atrioventricular synchrony will be calculated based on the recording of a 20-minute resting period in the outpatient consulting room, via dividing the total number of AV synchronous cycles by the total number of cardiac cycles recoded by a Holter. An AV synchronous cycle will be defined as a paced or sensed ventricular beat within 300 ms following a surface ECG confirmed P-wave.
Measured: 6, 12 months post-implant
Ventricular pacing threshold, at 3 months, 6 months, and 1 year after Micra AV implantation.
Measuring the ventricular pacing threshold by a programmer at the outpatient clinic at 3,6 and 12 month.
Measured: 3, 6, 12months post-implant
Ventricular sensing at 3 months, 6 months, and 1 year after Micra AV implantation.
Measuring ventricular sensing by a programmer at the outpatient clinic at 3,6 and 12 month.
Measured: 3, 6, 12 months post-implant
Impedance at 3 months, 6months, and 1 year after Micra AV implantation.
Measuring Impedance by a programmer at the outpatient clinic at 3,6 and 12 month.
Measured: 3, 6, 12 months post-implant
Major complications related to the device implantation at perioperative period, and 3, 6, 9, 12 months after Micra AV implantation
Major complations related to the device implantation include, pericardial effusion, dislodgement, threshold elevation or loss of capture, infection, etc.
Measured: Days 0,1 and 3, 6, 9, 12 months post- implant
All-cause mortality rates at 3 months, 6 months, and 1 year after Micra AV implantation.
These data will be collected at the outpatient clinic at 3,6 and 12 month, 9-month follow-up will be conducted via telephone.
Measured: 3, 6, 9, 12 months post-implant
Rehospitalization events related to heart failure at 3 months, 6 months, and 1year after Micra AV implantation.
Rehospitalization events due to heart failure at 3 months, 6 months, and 1year after Micra AV implantation.
Measured: 3, 6, 12 months post-implant
Tachycardia related to the pacemaker, or adverse events related to the device or algorithm at 3, 6, 12 months after Micra AV implantation.
Tachycardia or or adverse events related to the device or algorithm during the follow-up
Measured: 3,6,12 months post-implant
Left venriculat ejection fraction measured by echocardiography at 6, 12 months after Micra AV implanted
Left venriculat ejection fraction measured by echocardiography.
Measured: 6, 12 months post-implant
Left ventricular end-diastolic diameter measured by echocardiography at 6, 12 months after Micra AV implantation.
Left ventricular end-diastolic diameter measured by echocardiography
Measured: 6, 12 months post-implant
Parameter adjustment events related to the synchrony less than 70% at 3, 6, 12 months after Micra AV implantation..
Parameter adjustment event will be defined as optimamizing the pacemaker parameters due to synchrony less than 70%.
Measured: 3, 6, 12months post-implant
Arrhythmias events at 3, 6, 12 months after Micra AV implantion
All kinds of arrhythmias events recorded via electrocardiogram or device during the follow up
Measured: 3, 6, 12months post-implant
Syncope events at 3, 6, 12 months after Micra AV implantion
Syncope events during the follow up
Measured: 3, 6, 12months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Sep 2024 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PacemakerStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaohan Fan
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Chest Hospital, Beijing Friendship Hospital, Beijing Hospital, Peking University First Hospital
- Responsible party
- Sponsor-investigator, Xiaohan Fan, Fu Wai Hospital, Beijing, China
- Investigators
- Xiaohan Fan, MD,PhD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587672
- Sponsor's protocol ID
- 2024-ZX028
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wilkoff BL. How to treat and identify device infections. Heart Rhythm. 2007 Nov;4(11):1467-70. doi: 10.1016/j.hrthm.2007.08.007. Epub 2007 Aug 11. No abstract available.
PubMed 17954409Johansen JB, Jorgensen OD, Moller M, Arnsbo P, Mortensen PT, Nielsen JC. Infection after pacemaker implantation: infection rates and risk factors associated with infection in a population-based cohort study of 46299 consecutive patients. Eur Heart J. 2011 Apr;32(8):991-8. doi: 10.1093/eurheartj/ehq497. Epub 2011 Jan 20.
PubMed 21252172Knops RE, Tjong FV, Neuzil P, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Reddy VY. Chronic performance of a leadless cardiac pacemaker: 1-year follow-up of the LEADLESS trial. J Am Coll Cardiol. 2015 Apr 21;65(15):1497-504. doi: 10.1016/j.jacc.2015.02.022.
PubMed 25881930Reddy VY, Knops RE, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Tjong FV, Jacobson P, Ostrosff A, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Neuzil P. Permanent leadless cardiac pacing: results of the LEADLESS trial. Circulation. 2014 Apr 8;129(14):1466-71. doi: 10.1161/CIRCULATIONAHA.113.006987. Epub 2014 Mar 24.
PubMed 24664277Reynolds DW, Ritter P. A Leadless Intracardiac Transcatheter Pacing System. N Engl J Med. 2016 Jun 30;374(26):2604-5. doi: 10.1056/NEJMc1604852. No abstract available.
PubMed 27355552Ann HW, Ahn JY, Jeon YD, Jung IY, Jeong SJ, Joung B, Lee M, Ku NS, Han SH, Kim JM, Choi JY. Incidence of and risk factors for infectious complications in patients with cardiac device implantation. Int J Infect Dis. 2015 Jul;36:9-14. doi: 10.1016/j.ijid.2015.05.011. Epub 2015 May 14.
PubMed 25980618
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Selection of Leadless Pacemaker in Patients With Atrioventricular Block and Atrioventricular Synchronous Pacing Status With a Micra AV: a Multicenter, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT06587672
- Acronym / sponsor ID
- 2024-ZX028
- Conditions
- Pacemaker, Atrioventricular Block, Clinical Trials, Pacing
- Keywords
- Leadless pacing, Atrioventricular synchrony, Atrioventricular block, Atrial contraction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Xiaohan FanUniversity, hospital or other
- Collaborators
- Tianjin Chest Hospital, Beijing Friendship Hospital, Beijing Hospital, Peking University First Hospital
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 19 Sep 2024 (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 multicenter, prospective, observational study ,the aim of this study is to find factors affecting selection of double-chamber leadless pacemaker in patients with atrioventricular block and ambulatory atrioventricular synchronous pacing status over time using a leadless ventricular pacemaker.
Detailed description
Traditional pacemakers consist of a pulse generator and leads. Infections of the pulse generator pocket and lead-related complications are unavoidable issues in the application oftraditional pacemakers.Leadless pacemakers have emerged to address complications associated with the pacemaker pocket and leads in specific patients.The initial design of leadless pacemakers focused on single-chamber (right ventricular)sensing and pacing,However, patients with sinus rhythm may experience pacemakersyndrome symptoms due to atrioventricular desynchrony. Furthermore, a high proportion of atrioventricular dyssynchronous ventricular pacing might increase hospitalization rates for atrial fibrillation and heart failure.Recent developments in leadless dual-chamber pacemakersutilize a built-in triaxial accelerometer.This study aims to investigate factors considered by patients with atrioventricular block and clinical pacemaker implanting physicians when make sure the use of Micra AV. 2). It also seeks to evaluate the atrioventricular synchrony of Micra AV pacing in patients during both exercise and rest, while analyzing factors that influence the AV synchrony.For all screened patients, a questionnaire is required to be finished with data including age, gender, occupation, educational level, clinical history, comorbidities, previous infections, history of implanted electronic devices, economic status, and medical insurance conditions. At same time, all physicians are asked to complete a questionnaire for analyzing the factors influencing the decision of device option.An ambulatory electrocardiogram will be performed at 3 months, 6 months, and 1 year follow-up after device implantation. Data regarding the proportion of atrioventricular Research Protocol Template (Observational Study)_V1.0_2023.10.04 7/10 synchrony, atrial sensing atrial contraction mechanical wave (A4) threshold, ventricular pacing threshold, sensing, and impedance will be tested and collected. Postoperative exercise related symptoms and adverse events will be routinely tracked.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients received Micra AV implantation | – | Device: Micra AV implantationPatients received Micra AV implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with atrioventricular conduction block, meeting the indications for dual-chamber leadless pacemakers as per the "Chinese Expert Consensus on Clinical Application of Leadless Pacemakers (2022)".All patients should sign written informed consent for agreement of the implantation procedure.
Key inclusion criteria (4 listed)
- Patients diagnosed with atrioventricular conduction block, meeting the indications for dual-chamber leadless pacemakers as per the "Chinese Expert Consensus on Clinical Application of Leadless Pacemakers (2022)".
- Age ≥18 years.
- Expected lifespan ≥1 year.
- Consent to sign an informed consent form and cooperate in the collection of baseline data and subsequent follow-ups
Key exclusion criteria (5 listed)
- Patients anticipated to have a high ventricular pacing proportion (>40%) and with left ventricular ejection fraction less than 50%.
- Patients with persistent atrial fibrillation and a high expected ventricular pacing proportion.
- Post-tricuspid valve mechanical valve replacement surgery.
- Patients with inferior vena cava pathway anomalies, precluding passage of the leadless pacemaker's delivery sheath.
- Patients with an expected lifespan of less than 1 year. 6 Patients who are pregnant, planning pregnancy, or undergoing cardiac transplantation.
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 |
|---|---|---|
| Micra AV implantationPatients received Micra AV implantation | Device | Patients received Micra AV implantation |
Primary outcome
Complete the survey questionnair before implanting a pacemaker
Time frame: 1 day before implanting a pacemaker
Complete the survey questionnair
The percentage of atrioventricular synchrony at 3 months after Micra AV implantation.
Time frame: 3 months post-implant
The percentage of atrioventricular synchrony will be calculated based on the recording of a 20-minute resting period in the outpatient consulting room, via dividing the total number of AV synchronous cycles by the total number of cardiac cycles recoded by a Holter. An AV synchronous cycle will be defined as a paced or sensed ventricular beat within 300 ms following a surface ECG confirmed P-wave.
14 secondary outcomes
Immediate success rate of Micra AV implantation.
Time frame: During implantation on day 0
The percentage of atrioventricular synchrony at 6, 12 months after Micra AV implantation.
Time frame: 6, 12 months post-implant
Ventricular pacing threshold, at 3 months, 6 months, and 1 year after Micra AV implantation.
Time frame: 3, 6, 12months post-implant
Ventricular sensing at 3 months, 6 months, and 1 year after Micra AV implantation.
Time frame: 3, 6, 12 months post-implant
Impedance at 3 months, 6months, and 1 year after Micra AV implantation.
Time frame: 3, 6, 12 months post-implant
Major complications related to the device implantation at perioperative period, and 3, 6, 9, 12 months after Micra AV implantation
Time frame: Days 0,1 and 3, 6, 9, 12 months post- implant
All-cause mortality rates at 3 months, 6 months, and 1 year after Micra AV implantation.
Time frame: 3, 6, 9, 12 months post-implant
Rehospitalization events related to heart failure at 3 months, 6 months, and 1year after Micra AV implantation.
Time frame: 3, 6, 12 months post-implant
Tachycardia related to the pacemaker, or adverse events related to the device or algorithm at 3, 6, 12 months after Micra AV implantation.
Time frame: 3,6,12 months post-implant
Left venriculat ejection fraction measured by echocardiography at 6, 12 months after Micra AV implanted
Time frame: 6, 12 months post-implant
Left ventricular end-diastolic diameter measured by echocardiography at 6, 12 months after Micra AV implantation.
Time frame: 6, 12 months post-implant
Parameter adjustment events related to the synchrony less than 70% at 3, 6, 12 months after Micra AV implantation..
Time frame: 3, 6, 12months post-implant
Arrhythmias events at 3, 6, 12 months after Micra AV implantion
Time frame: 3, 6, 12months post-implant
Syncope events at 3, 6, 12 months after Micra AV implantion
Time frame: 3, 6, 12months post-implant
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 19 Sep 2024.
- Background: PubMed 17954409Wilkoff BL. How to treat and identify device infections. Heart Rhythm. 2007 Nov;4(11):1467-70. doi: 10.1016/j.hrthm.2007.08.007. Epub 2007 Aug 11. No abstract available.
- Background: PubMed 21252172Johansen JB, Jorgensen OD, Moller M, Arnsbo P, Mortensen PT, Nielsen JC. Infection after pacemaker implantation: infection rates and risk factors associated with infection in a population-based cohort study of 46299 consecutive patients. Eur Heart J. 2011 Apr;32(8):991-8. doi: 10.1093/eurheartj/ehq497. Epub 2011 Jan 20.
- Background: PubMed 25881930Knops RE, Tjong FV, Neuzil P, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Reddy VY. Chronic performance of a leadless cardiac pacemaker: 1-year follow-up of the LEADLESS trial. J Am Coll Cardiol. 2015 Apr 21;65(15):1497-504. doi: 10.1016/j.jacc.2015.02.022.
- Background: PubMed 24664277Reddy VY, Knops RE, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Tjong FV, Jacobson P, Ostrosff A, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Neuzil P. Permanent leadless cardiac pacing: results of the LEADLESS trial. Circulation. 2014 Apr 8;129(14):1466-71. doi: 10.1161/CIRCULATIONAHA.113.006987. Epub 2014 Mar 24.
- Background: PubMed 27355552Reynolds DW, Ritter P. A Leadless Intracardiac Transcatheter Pacing System. N Engl J Med. 2016 Jun 30;374(26):2604-5. doi: 10.1056/NEJMc1604852. No abstract available.
- Results publication: PubMed 25980618Ann HW, Ahn JY, Jeon YD, Jung IY, Jeong SJ, Joung B, Lee M, Ku NS, Han SH, Kim JM, Choi JY. Incidence of and risk factors for infectious complications in patients with cardiac device implantation. Int J Infect Dis. 2015 Jul;36:9-14. doi: 10.1016/j.ijid.2015.05.011. Epub 2015 May 14.
- 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.
Xiaohan Fan, MD,PhD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pacemaker and Atrioventricular Block, run by Xiaohan Fan at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Contact Xiaohan Fan (+861088322393 ext. +861088322393, fanxiaohan@fuwaihospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete the survey questionnair before implanting a pacemaker (time frame: 1 day before implanting a pacemaker). 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 NCT06587672, which also lists 6 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 19 Sep 2024.