Calcific Aortic StenosisRACNCT03343314

Effective Management of Calcific Aortic Stenosis in the Elderly

An observational study of Calcific Aortic Stenosis, run by French Cardiology Society.

Completed

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

Trial summary

Although aortic valve replacement is recommended for any symptomatic severe calcific aortic stenosis, the therapeutic decision may be difficult. because of patient age and comorbidities. Read more about this study

Who is it for?: Ages 75 years and older
Conditions the study is for: Calcific Aortic Stenosis
How many people: 1,101 participants
Where: No sites listed yet
Study dates: Sep 2016to Dec 2018
Phase: Observational
Are there results?: None posted in the registry

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 75 years and older
All sexes
No healthy volunteers
Older adult

Study population: Multicenter study to prospectively include all patients who agreed to participate in the study, with severe and symptomatic aortic stenosis, and hospitalized in one of the medical-surgical centers participating in the study and offering all the therapeutic resources for the taking into account charge of patients with aortic stenosis

Who may be able to join

Hospitalized due to symptomatic tight aortic stenosis (NYHA >= II, dyspnea, angina or syncope);
Having given his consent to participate in the study.

Who cannot join

Non-severe aortic stenosis;
Asymptomatic aortic stenosis;
Patient under the age of 75;
Patient refusing to participate in the study.

About this study

Although aortic valve replacement is recommended for any symptomatic severe calcific aortic stenosis, the therapeutic decision may be difficult. because of patient age and comorbidities.

Transcatheter Aortic Valve Implantation (TAVI) has recently extended the therapeutic indications in patients at high risk of surgery. However, the proportion of different treatments is not known in a contemporary population that can be treated according to the different resources currently available.

The scientific goal of this observational research is to evaluate intra-hospital therapeutic decision in elderly patients referred because of symptomatic severe aortic stenosis.

The one-year survival will be analyzed according to the therapeutic decision and the characteristics of the patients.

Conditions: Calcific Aortic Stenosis
Medical subject headings: Aortic Valve, Calcification of

What participants receive

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

Study groups in NCT03343314
Study group	Role	What they receive
Hospitalized patients due to a severe, symptomatic aortic sten		Patients who agreed to participate in the study, aged ≥75 years, with severe and symptomatic aortic stenosis, and hospitalized in one of the medical and surgical centers participating in the study

What is being measured

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

Collate the therapeutic decision (medical treatment, TAVI [Transcatheter Aortic Valve Implantation] or surgical aortic valve replacement) comprehensively for all hospitalized patients because of a severe, symptomatic RAC.
The primary endpoint is the therapeutic indication retained by the medical-surgical team in charge of the patient during hospitalization: medical treatment, TAVI or surgical aortic valve replacement.
Measured: 1 day

Secondary outcomes (1)

1 year-survival
Survival at one year will be analyzed. The analysis of the relationship between therapeutic decision and survival will be studied by taking surgical aortic valve replacement as a reference class.
Measured: 1 year

Timeline

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

Sep 2016Dec 2018

First posted17 Nov 2017
Study startSep 2016
Primary completionApr 2017
Study completionDec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Calcific Aortic StenosisStudies 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: Cohort
Time perspective: Prospective
Enrolment: 1,101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03343314
Sponsor's protocol ID: 15945
Acronym: RAC
Status last verified: Aug 2019
First submitted: 10 Nov 2017
Last updated: 7 Aug 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Iung B, Vahanian A. Epidemiology of valvular heart disease in the adult. Nat Rev Cardiol. 2011 Mar;8(3):162-72. doi: 10.1038/nrcardio.2010.202. Epub 2011 Jan 25.
PubMed 21263455
Iung B, Vahanian A. Degenerative calcific aortic stenosis: a natural history. Heart. 2012 Nov;98 Suppl 4:iv7-13. doi: 10.1136/heartjnl-2012-302395.
PubMed 23143128
Iung B, Cachier A, Baron G, Messika-Zeitoun D, Delahaye F, Tornos P, Gohlke-Barwolf C, Boersma E, Ravaud P, Vahanian A. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J. 2005 Dec;26(24):2714-20. doi: 10.1093/eurheartj/ehi471. Epub 2005 Sep 1.
PubMed 16141261
Bach DS, Cimino N, Deeb GM. Unoperated patients with severe aortic stenosis. J Am Coll Cardiol. 2007 Nov 13;50(20):2018-9. doi: 10.1016/j.jacc.2007.08.011. Epub 2007 Oct 29. No abstract available.
PubMed 17996571
Freed BH, Sugeng L, Furlong K, Mor-Avi V, Raman J, Jeevanandam V, Lang RM. Reasons for nonadherence to guidelines for aortic valve replacement in patients with severe aortic stenosis and potential solutions. Am J Cardiol. 2010 May 1;105(9):1339-42. doi: 10.1016/j.amjcard.2009.12.056. Epub 2010 Mar 11.
PubMed 20403489
Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012 May 3;366(18):1686-95. doi: 10.1056/NEJMoa1200384. Epub 2012 Mar 26.
PubMed 22443479
Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29.
PubMed 24678937
Osnabrugge RL, Mylotte D, Head SJ, Van Mieghem NM, Nkomo VT, LeReun CM, Bogers AJ, Piazza N, Kappetein AP. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol. 2013 Sep 10;62(11):1002-12. doi: 10.1016/j.jacc.2013.05.015. Epub 2013 May 30.
PubMed 23727214
Martinez-Selles M, Gomez Doblas JJ, Carro Hevia A, Garcia de la Villa B, Ferreira-Gonzalez I, Alonso Tello A, Andion Ogando R, Ripoll Vera T, Arribas Jimenez A, Carrillo P, Rodriguez Pascual C, Casares i Romeva M, Borras X, Cornide L, Lopez-Palop R; PEGASO Registry Group. Prospective registry of symptomatic severe aortic stenosis in octogenarians: a need for intervention. J Intern Med. 2014 Jun;275(6):608-20. doi: 10.1111/joim.12174. Epub 2014 Mar 27.
PubMed 24320176
Mylotte D, Osnabrugge RLJ, Windecker S, Lefevre T, de Jaegere P, Jeger R, Wenaweser P, Maisano F, Moat N, Sondergaard L, Bosmans J, Teles RC, Martucci G, Manoharan G, Garcia E, Van Mieghem NM, Kappetein AP, Serruys PW, Lange R, Piazza N. Transcatheter aortic valve replacement in Europe: adoption trends and factors influencing device utilization. J Am Coll Cardiol. 2013 Jul 16;62(3):210-219. doi: 10.1016/j.jacc.2013.03.074. Epub 2013 May 15.
PubMed 23684674
Eltchaninoff H, Prat A, Gilard M, Leguerrier A, Blanchard D, Fournial G, Iung B, Donzeau-Gouge P, Tribouilloy C, Debrux JL, Pavie A, Gueret P; FRANCE Registry Investigators. Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry. Eur Heart J. 2011 Jan;32(2):191-7. doi: 10.1093/eurheartj/ehq261. Epub 2010 Sep 15.
PubMed 20843959
Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Lefevre T, Himbert D, Tchetche D, Carrie D, Albat B, Cribier A, Rioufol G, Sudre A, Blanchard D, Collet F, Dos Santos P, Meneveau N, Tirouvanziam A, Caussin C, Guyon P, Boschat J, Le Breton H, Collart F, Houel R, Delpine S, Souteyrand G, Favereau X, Ohlmann P, Doisy V, Grollier G, Gommeaux A, Claudel JP, Bourlon F, Bertrand B, Van Belle E, Laskar M; FRANCE 2 Investigators. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012 May 3;366(18):1705-15. doi: 10.1056/NEJMoa1114705.
PubMed 22551129
Nashef SA, Roques F, Sharples LD, Nilsson J, Smith C, Goldstone AR, Lockowandt U. EuroSCORE II. Eur J Cardiothorac Surg. 2012 Apr;41(4):734-44; discussion 744-5. doi: 10.1093/ejcts/ezs043. Epub 2012 Feb 29.
PubMed 22378855
Iung B, Laouenan C, Himbert D, Eltchaninoff H, Chevreul K, Donzeau-Gouge P, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Laskar M, Vahanian A, Gilard M; FRANCE 2 Investigators. Predictive factors of early mortality after transcatheter aortic valve implantation: individual risk assessment using a simple score. Heart. 2014 Jul;100(13):1016-23. doi: 10.1136/heartjnl-2013-305314. Epub 2014 Apr 16.
PubMed 24740804
Vahanian A, Alfieri O, Andreotti F, Antunes MJ, Baron-Esquivias G, Baumgartner H, Borger MA, Carrel TP, De Bonis M, Evangelista A, Falk V, Lung B, Lancellotti P, Pierard L, Price S, Schafers HJ, Schuler G, Stepinska J, Swedberg K, Takkenberg J, Von Oppell UO, Windecker S, Zamorano JL, Zembala M; ESC Committee for Practice Guidelines (CPG); Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC); European Association for Cardio-Thoracic Surgery (EACTS). Guidelines on the management of valvular heart disease (version 2012): the Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2012 Oct;42(4):S1-44. doi: 10.1093/ejcts/ezs455. Epub 2012 Aug 25. No abstract available.
PubMed 22922698

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?

Official record

Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Active, not recruiting
Target Value Study to Evaluate the Safety and Efficacy of the Taurus NXT® Transcatheter Aortic Valve System for the Treatment of Severe Calcific Aortic Stenosis
Aortic Stenosis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
Vericiguat for the Inhibition of Calcific Aortic Valve Stenosis Progression
Calcific Aortic Valve Disease, AORTIC VALVE DISEASES
Active, not recruiting
DurAVR™ THV EU-EFS
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis

All Calcific Aortic Stenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effective Management of Calcific Aortic Stenosis in the Elderly
ClinicalTrials.gov ID: NCT03343314
Acronym / sponsor ID: RAC / 15945
Conditions: Calcific Aortic Stenosis
Study type: Observational
Recruitment status: Completed
Enrolment: 1,101 participants (actual)
Lead sponsor: French Cardiology SocietyUniversity, hospital or other
Study start: Sep 2016 (actual)
Primary completion: Apr 2017 (actual)
Study completion: Dec 2018 (actual)
First posted: 17 Nov 2017 (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.

Although aortic valve replacement is recommended for any symptomatic severe calcific aortic stenosis, the therapeutic decision may be difficult. because of patient age and comorbidities.

The scientific goal of this observational research is to evaluate intra-hospital therapeutic decision in elderly patients referred because of symptomatic severe aortic stenosis.

The one-year survival will be analyzed according to the therapeutic decision and the characteristics of the patients.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Hospitalized patients due to a severe, symptomatic aortic sten	–	–Patients who agreed to participate in the study, aged ≥75 years, with severe and symptomatic aortic stenosis, and hospitalized in one of the medical and surgical centers participating in the study

Who may qualify

Ages: 75 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult
Study population: Multicenter study to prospectively include all patients who agreed to participate in the study, with severe and symptomatic aortic stenosis, and hospitalized in one of the medical-surgical centers participating in the study and offering all the therapeutic resources for the taking into account charge of patients with aortic stenosis

Key inclusion criteria (2 listed)

Hospitalized due to symptomatic tight aortic stenosis (NYHA >= II, dyspnea, angina or syncope);
Having given his consent to participate in the study.

Key exclusion criteria (4 listed)

Non-severe aortic stenosis;
Asymptomatic aortic stenosis;
Patient under the age of 75;
Patient refusing to participate in the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Collate the therapeutic decision (medical treatment, TAVI [Transcatheter Aortic Valve Implantation] or surgical aortic valve replacement) comprehensively for all hospitalized patients because of a severe, symptomatic RAC.
Time frame: 1 day
The primary endpoint is the therapeutic indication retained by the medical-surgical team in charge of the patient during hospitalization: medical treatment, TAVI or surgical aortic valve replacement.

1 secondary outcome

1 year-survival
Time frame: 1 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
Background: PubMed 21263455Iung B, Vahanian A. Epidemiology of valvular heart disease in the adult. Nat Rev Cardiol. 2011 Mar;8(3):162-72. doi: 10.1038/nrcardio.2010.202. Epub 2011 Jan 25.
Background: PubMed 23143128Iung B, Vahanian A. Degenerative calcific aortic stenosis: a natural history. Heart. 2012 Nov;98 Suppl 4:iv7-13. doi: 10.1136/heartjnl-2012-302395.
Background: PubMed 16141261Iung B, Cachier A, Baron G, Messika-Zeitoun D, Delahaye F, Tornos P, Gohlke-Barwolf C, Boersma E, Ravaud P, Vahanian A. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J. 2005 Dec;26(24):2714-20. doi: 10.1093/eurheartj/ehi471. Epub 2005 Sep 1.
Background: PubMed 17996571Bach DS, Cimino N, Deeb GM. Unoperated patients with severe aortic stenosis. J Am Coll Cardiol. 2007 Nov 13;50(20):2018-9. doi: 10.1016/j.jacc.2007.08.011. Epub 2007 Oct 29. No abstract available.
Background: PubMed 20403489Freed BH, Sugeng L, Furlong K, Mor-Avi V, Raman J, Jeevanandam V, Lang RM. Reasons for nonadherence to guidelines for aortic valve replacement in patients with severe aortic stenosis and potential solutions. Am J Cardiol. 2010 May 1;105(9):1339-42. doi: 10.1016/j.amjcard.2009.12.056. Epub 2010 Mar 11.
Background: PubMed 22443479Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012 May 3;366(18):1686-95. doi: 10.1056/NEJMoa1200384. Epub 2012 Mar 26.
Background: PubMed 24678937Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM, Gleason TG, Buchbinder M, Hermiller J Jr, Kleiman NS, Chetcuti S, Heiser J, Merhi W, Zorn G, Tadros P, Robinson N, Petrossian G, Hughes GC, Harrison JK, Conte J, Maini B, Mumtaz M, Chenoweth S, Oh JK; U.S. CoreValve Clinical Investigators. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 May 8;370(19):1790-8. doi: 10.1056/NEJMoa1400590. Epub 2014 Mar 29.
Background: PubMed 23727214Osnabrugge RL, Mylotte D, Head SJ, Van Mieghem NM, Nkomo VT, LeReun CM, Bogers AJ, Piazza N, Kappetein AP. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol. 2013 Sep 10;62(11):1002-12. doi: 10.1016/j.jacc.2013.05.015. Epub 2013 May 30.
Background: PubMed 24320176Martinez-Selles M, Gomez Doblas JJ, Carro Hevia A, Garcia de la Villa B, Ferreira-Gonzalez I, Alonso Tello A, Andion Ogando R, Ripoll Vera T, Arribas Jimenez A, Carrillo P, Rodriguez Pascual C, Casares i Romeva M, Borras X, Cornide L, Lopez-Palop R; PEGASO Registry Group. Prospective registry of symptomatic severe aortic stenosis in octogenarians: a need for intervention. J Intern Med. 2014 Jun;275(6):608-20. doi: 10.1111/joim.12174. Epub 2014 Mar 27.
Background: PubMed 23684674Mylotte D, Osnabrugge RLJ, Windecker S, Lefevre T, de Jaegere P, Jeger R, Wenaweser P, Maisano F, Moat N, Sondergaard L, Bosmans J, Teles RC, Martucci G, Manoharan G, Garcia E, Van Mieghem NM, Kappetein AP, Serruys PW, Lange R, Piazza N. Transcatheter aortic valve replacement in Europe: adoption trends and factors influencing device utilization. J Am Coll Cardiol. 2013 Jul 16;62(3):210-219. doi: 10.1016/j.jacc.2013.03.074. Epub 2013 May 15.
Background: PubMed 20843959Eltchaninoff H, Prat A, Gilard M, Leguerrier A, Blanchard D, Fournial G, Iung B, Donzeau-Gouge P, Tribouilloy C, Debrux JL, Pavie A, Gueret P; FRANCE Registry Investigators. Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry. Eur Heart J. 2011 Jan;32(2):191-7. doi: 10.1093/eurheartj/ehq261. Epub 2010 Sep 15.
Background: PubMed 22551129Gilard M, Eltchaninoff H, Iung B, Donzeau-Gouge P, Chevreul K, Fajadet J, Leprince P, Leguerrier A, Lievre M, Prat A, Teiger E, Lefevre T, Himbert D, Tchetche D, Carrie D, Albat B, Cribier A, Rioufol G, Sudre A, Blanchard D, Collet F, Dos Santos P, Meneveau N, Tirouvanziam A, Caussin C, Guyon P, Boschat J, Le Breton H, Collart F, Houel R, Delpine S, Souteyrand G, Favereau X, Ohlmann P, Doisy V, Grollier G, Gommeaux A, Claudel JP, Bourlon F, Bertrand B, Van Belle E, Laskar M; FRANCE 2 Investigators. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012 May 3;366(18):1705-15. doi: 10.1056/NEJMoa1114705.
Individual participant dataSharing planned: No

Related trials for Calcific Aortic Stenosis

Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Active, not recruiting
Target Value Study to Evaluate the Safety and Efficacy of the Taurus NXT® Transcatheter Aortic Valve System for the Treatment of Severe Calcific Aortic Stenosis
Aortic Stenosis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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RecruitingPhase 2
Vericiguat for the Inhibition of Calcific Aortic Valve Stenosis Progression
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Calcific Aortic Stenosis, run by French Cardiology Society.

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 2 inclusion and 4 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 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Collate the therapeutic decision (medical treatment, TAVI [Transcatheter Aortic Valve Implantation] or surgical aortic valve replacement) comprehensively for all hospitalized patients because of a severe, symptomatic RAC. (time frame: 1 day). 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 NCT03343314, which also lists 15 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 7 Aug 2019.