Long-standing Persistent Atrial FibrillationSINUSNCT06516822
CPVI With Modified Linear Ablation Versus CPVI in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)
A study testing CPVI-MLA and CPVI only in people with Long-standing Persistent Atrial Fibrillation and Ablation, run by The First Affiliated Hospital with Nanjing Medical University at 10 sites in China.
Trial summary
Catheter ablation has become as the first-line treatment for patients with symptomatic atrial fibrillation (AF). As the cornerstone of catheter ablation for AF, the safety and efficacy of circumferential pulmonary vein isolation (CPVI) have been confirmed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Long-standing Persistent Atrial Fibrillation, Ablation
- What is being tested?
- CPVI-MLA and CPVI only
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 10 sitesChina
- Study dates
- 31 Jul 2024to Dec 2027
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients with symptomatic LSPAF refractory to at least one antiarrhythmic drug; LSPAF will be defined as a sustained AF episode lasting ≥ 1 year;
- AF duration 1-3 years;
- Age 18 - 75 years;
- Left atrial diameter (LAD) 43-55 mm on long axis parasternal view;
- AF recorded within 3 years of enrollment;
- Patient willing and able to comply with protocol and sign informed consent
Who cannot join
- Paroxysmal atrial fibrillation;
- Persistent AF lasting < 1 year or >3 years;
- Left atrial thrombosis;
- Patients with a history of catheter ablation for AF;
- Patients with severe structural heart disease (severe valvular heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, etc.);
- LAD > 55mm on long axis parasternal view;
Show all 33Show fewer
- Left ventricular ejection fraction (LVEF) < 40%;
- Patients with contraindications to low molecular weight heparin, warfarin or novel oral anticoagulants;
- One-stop procedure for AF ablation and left atrial appendage occlusion;
- Alcohol allergy or contrast agent allergy;
- Patients taking cephalosporin antibiotics within 72 hours prior to ablation;
- Pulmonary artery systolic pressure > 50mmHg;
- Patients with unstable angina pectoris;
- Patients who had undergone percutaneous coronary intervention (PCI) within 3 months;
- Patients who had undergone surgery within 6 months;
- Patients ready to receive heart transplantation;
- Patients with a history of thromboembolism within 6 months;
- Patients with diagnosed atrial myxoma;
- Patients with severe respiratory diseases;
- Patients with infectious diseases in active phase;
- Patients with poorly controlled systemic immune diseases;
- Patients with uncured malignant hematological diseases;
- Patients with uncured malignant solid tumors;
- Patients with untreated hypothyroidism or hyperthyroidism;
- Patients with severe liver dysfunction (elevation of transaminases [ALT or AST] >3 times the upper limit of normal range);
- Patients with end-stage renal failure requiring dialysis;
- Patients with other serious arrhythmias, such as ventricular tachycardia with hemodynamic instability;
- Pregnant and lactating women;
- Patients with psychiatric ailments;
- BMI < 18.5 or ≥ 30kg/m2;
- Life expectancy < 2 years;
- Patients unwilling or unable to give informed consent;
- Patients unwilling or unable to cooperate to complete follow-up.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Qiushi Chen, MD contact
10 sites in 1 country
China10 sites, 10 recruiting
- Not yet recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Yunlong Wang, Professor, Yunlong76818@126.com
- Not yet recruiting
Peking University third hospital
Beijing, Beijing Municipality, Beijing
Jin Bai, Professor, 13810700414@126.com
- Not yet recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
Xiaomeng Yin, Professor, dr.yinxm@163.com
- Not yet recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510235
Shuanglun Xie, Professor, xieshaunglun@sina.com
- Not yet recruiting
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250013
Hesheng Hu, Professor, hyperhhs@163.com
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Fengxiang Zhang, Professor, njzfx6@163.com
- Not yet recruiting
Shenzhen Hospital, Fuwai Hospital, Chinese Academy of Medical Science
Shenzhen, Guangdong, 518000
Teng Li, Professor, gdmc99@163.com
- Not yet recruiting
Taizhou First People's Hospital
Taizhou, Zhejiang, 318050
Weili Ge, Professor, gewl@enzemed.com
- Not yet recruiting
Xijing Hospital, Air Force Medical University
Xi’an, Shanxi, 710032
Fu Yi, Professor, yi12fu56@126.com
- Recruiting
Zhengzhou University People's Hospital, Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Shujuan Dong, Professor, hnsydsj@163.com
About this study
Official title: Circumferential Pulmonary Vein Isolation With Modified Linear Ablation Versus Circumferential Pulmonary Vein Isolation Only in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)
Catheter ablation has become as the first-line treatment for patients with symptomatic atrial fibrillation (AF). As the cornerstone of catheter ablation for AF, the safety and efficacy of circumferential pulmonary vein isolation (CPVI) have been confirmed. However, for persistent AF, especially for long-standing persistent AF (LSPAF), the recurrence rate is still high. Whether the ethanol infusion (EI) into the vein of Marshall (EI-VOM) and linear ablation could improve the success rate remains controversial.
The SINUS study is a prospective, multicenter, randomized trial, which is designed to compare the efficacy and safety between CPVI with modified linear ablation (CPVI-MLA) and CPVI only for the treatment of LSPAF.
Read the detailed description
The SINUS study will include 320 patients with LSPAF undergoing catheter ablation for the first time. All patients will be randomized to either the CPVI-MLA group or CPVI only group in a 1:1 ratio. The CPVI-MLA strategy is a fixed ablation approach consisting of EI-VOM, CPVI, left atrial posterior wall isolation (PWI), linear ablation of mitral isthmus (MI), left atrial intima adjoining CS (LAI-CS) and cavo-tricuspid isthmus (CTI), and superior vena cava isolation (SVCI). The follow-up is for a minimum of 12 months with rhythm monitoring. The primary endpoint is freedom from any documented atrial arrhythmia including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) > 30 seconds after the initial 3 months blanking period without the use of antiarrhythmic drugs (AADs), at 12 months after the index ablation procedure.
- Being tested
- CPVI-MLA, CPVI only
- Keywords
- long-standing persistent atrial fibrillation, circumferential pulmonary vein isolation, modified linear ablation, arrhythmia-free survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPVI-MLAProcedure or surgery
The details include: (1) EI-VOM procedure: An 8.5-French-long sheath is inserted into to the CS via the femoral vein. A JR4 catheter is inserted into the CS to identify the ostium of the VOM. Subsequently, a guide wire supported by an OTW balloon catheter is advanced into the VOM. The balloon is inflated at 6-8 atm pressure in the VOM. Ethanol is infused into VOM from distal to proximal with 3ml each time within 1-2min. After the distal EI-VOM, the balloon is deflated and adjusted to the middle part of VOM. The EI-VOM procedure in the proximal and middle part of VOM should be the same as that in the distal. After three times of EI-VOM, the contrast is injected into VOM to make it permeable and dispersed to observe the effect of alcohol ablation. (2) After EI-VOM, radiofrequency ablation is performed to achieve bilateral PVI, PWI, bidirectional block of MI and CTI, disappearance of LAI-CS potential and SVCI. (3) Any organized AT observed during the procedure is targeted as well.
CPVI onlyProcedure or surgery
After reconstructing the left atrial geometry, CPVI is performed. Radiofrequency ablation should be applied at least 1-2 cm outside of the PV ostia for PVI to achieve a wide PVI ring. The mapping catheter PentaRay will be used to confirm the complete isolation of the PV antrum when all PV potentials within each antrum are abolished. If the AF persists after CPVI, direct current cardioversion is then be conducted to restore sinus rhythm. If spontaneous AFL/AT occurs during ablation, ablation is performed targeting the focal or critical isthmus under the guidance of high-density activation mapping. The endpoint of CPVI is to achieve complete entrance and exit block of all PV antra as recorded by PentaRay during sinus rhythm or CS pacing.
| Study group | Role | What they receive |
|---|---|---|
| CPVI-MLA | Experimental | Patients randomized to the CPVI-MLA group first undergo ethanol infusion in the vein of Marshall (EI-VOM) followed by CPVI, left atrial posterior wall isolation (PWI), linear ablation of mitral isthmus (MI), left atrial intima adjoining CS (LAI-CS) and cavo-tricuspid isthmus (CTI), and superior vena cava isolation (SVCI). Receives: Procedure: CPVI-MLA |
| CPVI only | Active comparator | Patients randomized to the CPVI group undergo right PV ablation, followed by the left PV ablation. Radiofrequency ablation should be applied at least 1-2 cm outside of the PV ostia in a wide-area circumferential pattern. Complete CPVI is achieved when all PV potentials within each antrum recorded by the high-density mapping catheter are abolished. Receives: Procedure: CPVI only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from any documented atrial arrhythmia off AADs
Freedom from any documented atrial arrhythmia including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) > 30 seconds assessed by ECG and Holter after the initial 3 months blanking period without the use of antiarrhythmic drugs (AADs), after the index ablation procedure
Measured: 12 months
Secondary outcomes (14)
Freedom from any documented atrial arrhythmia on/off AADs
Freedom from any documented atrial arrhythmia > 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after the index ablation procedure on/off AADs.
Measured: 12 months
Freedom from any documented AF on/off AADs
Freedom from any documented AF episodes > 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after the index ablation procedure on/off AADs.
Measured: 12 months
Freedom from any documented AFL/AT on/off AADs
Freedom from any documented AFL/AT episodes > 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after the index ablation procedure on/off AADs.
Measured: 12 months
AF burden
AF burden (% time) on continuous monitoring during 12 months after the 3-months blanking period.
Measured: 12 months
Freedom from any documented AFL/AT on/off AADs in patients with successful EI-VOM
Freedom from any documented AFL/AT episodes > 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after the index ablation procedure on/off AADs in patients with successful EI-VOM.
Measured: 12 months
AF burden in patients with successful EI-VOM
AF burden (% time) on continuous monitoring during 12 months after the 3-months blanking period in patients with successful EI-VOM
Measured: 12 months
Freedom from AF/AFL/AT after multiple procedures
Freedom from any documented atrial arrhythmia > 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after more than one ablation procedure on/off AADs.
Measured: 12 months
Freedom from AF after multiple procedures
Freedom from any documented AF > 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after more than one ablation procedure on/off AADs.
Measured: 12 months
Freedom from AFL/AT after multiple procedures
Freedom from any documented AFL/AT > 30 seconds assessed by ECG and Holter after the initial 3 month blanking period, after more than one ablation procedure on/off AADs.
Measured: 12 months
AF burden after multiple procedures
AF burden (% time) on continuous monitoring during 12 months (after the 3-months blanking period) after multiple procedures
Measured: 12 months
Hospitalization for cardiovascular disease
Hospitalization for cardiovascular disease (e.g., atrial arrhythmia, heart failure and coronary heart disease)
Measured: 12 months
AFEQT score change between baseline and 12-month
Quality of life assessed by AF effect on quality-of-life (AFEQT) questionnaire
Measured: 12 months
EQ-5D-5L score change between baseline and 12-month
Quality of life assessed by EuroQol 5-dimension (EQ-5D-5L) scale
Measured: 12 months
Incidence of procedural complications
Cardiac tamponade or perforation, phrenic nerve injury, acute coronary occlusion, death, stroke / thromboembolism related to AF ablation, pulmonary vein stenosis, left atrial oesophageal fistula, and vascular complications requiring intervention (e.g., pseudoaneurysm, arteriovenous fistula).
Measured: Within 3 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start31 Jul 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-standing Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Fengxiang, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Fengxiang Zhang, MD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516822
- Sponsor's protocol ID
- 2023-SR-027.A1
- Acronym
- SINUS
- Status last verified
- Nov 2024
- First submitted
- 17 Jul 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data used and analyzed to support the study are available from the principal investigator on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circumferential Pulmonary Vein Isolation With Modified Linear Ablation Versus Circumferential Pulmonary Vein Isolation Only in Patients With Long-standing Persistent Atrial Fibrillation (SINUS)
- ClinicalTrials.gov ID
- NCT06516822
- Acronym / sponsor ID
- SINUS / 2023-SR-027.A1
- Keywords
- long-standing persistent atrial fibrillation, circumferential pulmonary vein isolation, modified linear ablation, arrhythmia-free survival
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Jul 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.
Catheter ablation has become as the first-line treatment for patients with symptomatic atrial fibrillation (AF). As the cornerstone of catheter ablation for AF, the safety and efficacy of circumferential pulmonary vein isolation (CPVI) have been confirmed. However, for persistent AF, especially for long-standing persistent AF (LSPAF), the recurrence rate is still high. Whether the ethanol infusion (EI) into the vein of Marshall (EI-VOM) and linear ablation could improve the success rate remains controversial.
The SINUS study is a prospective, multicenter, randomized trial, which is designed to compare the efficacy and safety between CPVI with modified linear ablation (CPVI-MLA) and CPVI only for the treatment of LSPAF.
Detailed description
The SINUS study will include 320 patients with LSPAF undergoing catheter ablation for the first time. All patients will be randomized to either the CPVI-MLA group or CPVI only group in a 1:1 ratio. The CPVI-MLA strategy is a fixed ablation approach consisting of EI-VOM, CPVI, left atrial posterior wall isolation (PWI), linear ablation of mitral isthmus (MI), left atrial intima adjoining CS (LAI-CS) and cavo-tricuspid isthmus (CTI), and superior vena cava isolation (SVCI). The follow-up is for a minimum of 12 months with rhythm monitoring. The primary endpoint is freedom from any documented atrial arrhythmia including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) > 30 seconds after the initial 3 months blanking period without the use of antiarrhythmic drugs (AADs), at 12 months after the index ablation procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPVI-MLA | Experimental | Procedure: CPVI-MLAPatients randomized to the CPVI-MLA group first undergo ethanol infusion in the vein of Marshall (EI-VOM) followed by CPVI, left atrial posterior wall isolation (PWI), linear ablation of mitral isthmus (MI), left atrial intima adjoining CS (LAI-CS) and cavo-tricuspid isthmus (CTI), and superior vena cava isolation (SVCI). |
| CPVI only | Active comparator | Procedure: CPVI onlyPatients randomized to the CPVI group undergo right PV ablation, followed by the left PV ablation. Radiofrequency ablation should be applied at least 1-2 cm outside of the PV ostia in a wide-area circumferential pattern. Complete CPVI is achieved when all PV potentials within each antrum recorded by the high-density mapping catheter are abolished. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Patients with symptomatic LSPAF refractory to at least one antiarrhythmic drug; LSPAF will be defined as a sustained AF episode lasting ≥ 1 year;
- AF duration 1-3 years;
- Age 18 - 75 years;
- Left atrial diameter (LAD) 43-55 mm on long axis parasternal view;
- AF recorded within 3 years of enrollment;
Key exclusion criteria (33 listed)
- Paroxysmal atrial fibrillation;
- Persistent AF lasting < 1 year or >3 years;
- Left atrial thrombosis;
- Patients with a history of catheter ablation for AF;
- Patients with severe structural heart disease (severe valvular heart disease, hypertrophic cardiomyopathy, dilated cardiomyopathy, etc.);
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 |
|---|---|---|
| CPVI-MLAThe details include: (1) EI-VOM procedure: An 8.5-French-long sheath is inserted into to the CS via the femoral vein. A JR4 catheter is inserted into the CS to identify the ostium of the VOM. Subsequently, a guide wire supported by an OTW balloon catheter is advanced into the VOM. The balloon is inflated at 6-8 atm pressure in the VOM. Ethanol is infused into VOM from distal to proximal with 3ml each time within 1-2min. After the distal EI-VOM, the balloon is deflated and adjusted to the middle part of VOM. The EI-VOM procedure in the proximal and middle part of VOM should be the same as that in the distal. After three times of EI-VOM, the contrast is injected into VOM to make it permeable and dispersed to observe the effect of alcohol ablation. (2) After EI-VOM, radiofrequency ablation is performed to achieve bilateral PVI, PWI, bidirectional block of MI and CTI, disappearance of LAI-CS potential and SVCI. (3) Any organized AT observed during the procedure is targeted as well. | Procedure or surgery | CPVI-MLA |
| CPVI onlyAfter reconstructing the left atrial geometry, CPVI is performed. Radiofrequency ablation should be applied at least 1-2 cm outside of the PV ostia for PVI to achieve a wide PVI ring. The mapping catheter PentaRay will be used to confirm the complete isolation of the PV antrum when all PV potentials within each antrum are abolished. If the AF persists after CPVI, direct current cardioversion is then be conducted to restore sinus rhythm. If spontaneous AFL/AT occurs during ablation, ablation is performed targeting the focal or critical isthmus under the guidance of high-density activation mapping. The endpoint of CPVI is to achieve complete entrance and exit block of all PV antra as recorded by PentaRay during sinus rhythm or CS pacing. | Procedure or surgery | CPVI only |
Primary outcome
Freedom from any documented atrial arrhythmia off AADs
Time frame: 12 months
Freedom from any documented atrial arrhythmia including atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) > 30 seconds assessed by ECG and Holter after the initial 3 months blanking period without the use of antiarrhythmic drugs (AADs), after the index ablation procedure
14 secondary outcomes
Freedom from any documented atrial arrhythmia on/off AADs
Time frame: 12 months
Freedom from any documented AF on/off AADs
Time frame: 12 months
Freedom from any documented AFL/AT on/off AADs
Time frame: 12 months
AF burden
Time frame: 12 months
Freedom from any documented AFL/AT on/off AADs in patients with successful EI-VOM
Time frame: 12 months
AF burden in patients with successful EI-VOM
Time frame: 12 months
Freedom from AF/AFL/AT after multiple procedures
Time frame: 12 months
Freedom from AF after multiple procedures
Time frame: 12 months
Freedom from AFL/AT after multiple procedures
Time frame: 12 months
AF burden after multiple procedures
Time frame: 12 months
Hospitalization for cardiovascular disease
Time frame: 12 months
AFEQT score change between baseline and 12-month
Time frame: 12 months
EQ-5D-5L score change between baseline and 12-month
Time frame: 12 months
Incidence of procedural complications
Time frame: Within 3 months after the procedure
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 8 Nov 2024.
- Individual participant dataSharing planned: No. The data used and analyzed to support the study are available from the principal investigator on reasonable request.
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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.
Qiushi Chen, MD contact
Fengxiang Zhang, MD principal investigator
The First Affiliated Hospital with Nanjing Medical University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPVI-MLA and CPVI only in people with Long-standing Persistent Atrial Fibrillation and Ablation, run by The First Affiliated Hospital with Nanjing Medical University at 10 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 6 inclusion and 33 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: looking for participants now, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 Yan Dong, MD (+86 18651908170, dy_medical@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from any documented atrial arrhythmia off AADs (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.