Atrial FibrillationNCT03636100
Release of Acetylcholine From the Ganglionated Plexus During the Thaw Phase of Cryoballon Pulmonary Vein Ablation (GP RESPONSE Study)
An observational study of Atrial Fibrillation, run by Saint Luke's Health System at 1 site in United States.
Trial summary
Determine whether the presence of acetylcholine in the systemic circulation, correlates with the hypotensive response observed during the thaw phase of cryoballoon ablation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Cryoballoon ablation
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2018to 11 Oct 2019
- 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: A total of 14 patients age 18-80 with atrial fibrillation undergoing first time cryoballoon ablation will be enrolled.
Who may be able to join
- patients with atrial fibrillation undergoing first time cryoballoon ablation
- age 18-80
Who cannot join
- any prior left atrial ablation or cardiac surgery
- hemoglobin level of <12.0 g/dL
- refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Luke's Mid America Heart Institute
Kansas City, Missouri, 64111
About this study
Official title: Systemic Release of Acetylcholine From the Autonomic Ganglionated Plexus: a Proposed Mechanism of Induced Hypotension During the Thaw Phase of Cryoballon Pulmonary Vein Ablation (GP RESPONSE Study)
Determine whether the presence of acetylcholine in the systemic circulation, correlates with the hypotensive response observed during the thaw phase of cryoballoon ablation.
Read the detailed description
This will be a two-phase (feasibility and primary study phases), prospective observational study with pulmonary vein ablation applications during which a hypotensive response is not observed serving as within-subject controls. A total of 14 patients age 18-80 with atrial fibrillation undergoing first time cryoballoon ablation will be enrolled. Exclusion criteria are any prior left atrial ablation or cardiac surgery, a hemoglobin level of < 12.0 g/dL, or refusal or inability to provide informed consent.
The ablation procedure will be carried out per routine clinical practice by one operator. Two cryoballoon applications targeting 180 seconds per application will be performed per vein. Applications may be abbreviated at the discretion of the operator for indications such as balloon temperatures reaching the mid -50s C, esophageal temperatures approaching 20 C, or a decrease in diaphragmatic movement during phrenic nerve pacing. Application times may be extended to 200 to 240 seconds, also at the discretion of the operator, if within-freeze target temperatures (such as -30 C by 30 seconds or -40 C by 60 seconds) are not met.
A hypotensive response will be defined as a transient ≥ 20% decrease in systolic blood pressure from baseline (start of thaw) during the thaw phase and up to 60 seconds post-end of thaw (balloon deflation). A partial hypotensive response will be defined as a transient 10-19% decrease in systolic blood pressure. For all patients, the time from the end of the cryoballoon freeze to the end of the thaw, to the onset of the hypotensive response, and to blood pressure recovery within 10% of baseline will be recorded. Blood pressure and heart rate will be recorded at each time point. For the first 4 patients (phase I), blood samples of 2-3mL each will be drawn from the mid-right atrium at baseline and then at 30, 60 and 90 seconds after the end of each cryoballoon freeze application. Samples will also be drawn at onset of hypotension and 30 seconds later (superseding the drawing of other samples in the first 90 seconds post-end of freeze), and at blood pressure recovery. Samples will be drawn within 10 seconds of each specified time point; or will not be obtained and will be marked as a missing data point. If more than 20% of the specified data are missing for a given subject, that subject will be excluded from analysis. The samples will then be run on a commercially available 96-well colorimetric assay kit by Cell Biolabs Inc (catalog number STA-603) to assay for acetylcholine.
If the first phase of the study demonstrates the presence of acetylcholine at one or more time points during the thaw phase of 20% or more of cryoballoon applications during which a hypotensive response is observed, the study will proceed to phase 2. The results will be used to determine the optimal time point(s) at which to obtain samples during the second phase of the study (remaining 10 patients), with an anticipated need for 2-4 samples per cryoballoon application, one at start of thaw, another at a determined time point, and when there is a hypotensive response at the onset of hypotension and at blood pressure recovery. An interim report will be produced detailing the observations of phase 1 and specifying the plan for obtaining samples in phase 2.
- Conditions
- Atrial Fibrillation
- Being tested
- Cryoballoon ablation
- Keywords
- Atrial fibrillation, Catheter ablation, Cryoballon ablation, Acetylcholine, Ganglionated plexus, Pulmonary veins, Pulmonary vein isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoballoon ablationDevice
Cryoballoon ablation using standard equipment and techniques
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual acetylcholine levels
With each subject serving as their own control, acetylcholine levels between ablation applications will be compared followed by a hypotensive response vs those that are not using paired T-tests.
Measured: 1 day
Secondary outcomes (1)
Group acetylcholine levels
Acetylcholine levels will be compared for the entire study group for applications followed by a hypotensive response vs those that are not. For this analysis each application will be treated as an independent unit and independent T-test will be used to compare acetylcholine levels.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start15 Aug 2018
- Primary completion11 Oct 2019
- Study completion11 Oct 2019
Why it stopped: After enrollment of half the subjects, the trial was unlikely to yield results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Luke's Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636100
- Sponsor's protocol ID
- GP Response
- Status last verified
- Oct 2021
- First submitted
- 15 Aug 2018
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andrade J, Khairy P, Dobrev D, Nattel S. The clinical profile and pathophysiology of atrial fibrillation: relationships among clinical features, epidemiology, and mechanisms. Circ Res. 2014 Apr 25;114(9):1453-68. doi: 10.1161/CIRCRESAHA.114.303211.
PubMed 24763464Kojodjojo P, O'Neill MD, Lim PB, Malcolm-Lawes L, Whinnett ZI, Salukhe TV, Linton NW, Lefroy D, Mason A, Wright I, Peters NS, Kanagaratnam P, Davies DW. Pulmonary venous isolation by antral ablation with a large cryoballoon for treatment of paroxysmal and persistent atrial fibrillation: medium-term outcomes and non-randomised comparison with pulmonary venous isolation by radiofrequency ablation. Heart. 2010 Sep;96(17):1379-84. doi: 10.1136/hrt.2009.192419.
PubMed 20801856Nakagawa H, Scherlag BJ, Patterson E, Ikeda A, Lockwood D, Jackman WM. Pathophysiologic basis of autonomic ganglionated plexus ablation in patients with atrial fibrillation. Heart Rhythm. 2009 Dec;6(12 Suppl):S26-34. doi: 10.1016/j.hrthm.2009.07.029. Epub 2009 Oct 24.
PubMed 19959140Ketels S, Houben R, Van Beeumen K, Tavernier R, Duytschaever M. Incidence, timing, and characteristics of acute changes in heart rate during ongoing circumferential pulmonary vein isolation. Europace. 2008 Dec;10(12):1406-14. doi: 10.1093/europace/eun287. Epub 2008 Oct 19.
PubMed 18936041Peyrol M, Barraud J, Koutbi L, Maille B, Trevisan L, Martinez E, Levy S, Paganelli F, Franceschi F. Vagal Reactions during Cryoballoon-Based Pulmonary Vein Isolation: A Clue for Autonomic Nervous System Modulation? Biomed Res Int. 2016;2016:7286074. doi: 10.1155/2016/7286074. Epub 2016 May 3.
PubMed 27243034Lemery R. Bradycardia with cooling and cryo: A reminder of the autonomic effects of cold stimuli on the heart. Heart Rhythm. 2016 May;13(5):1018-1019. doi: 10.1016/j.hrthm.2015.12.049. Epub 2016 Jan 6. No abstract available.
PubMed 26767424Bordignon S, Furnkranz A, Dugo D, Perrotta L, Gunawardene M, Bode F, Klemt A, Nowak B, Schulte-Hahn B, Schmidt B, Chun KR. Improved lesion formation using the novel 28 mm cryoballoon in atrial fibrillation ablation: analysis of biomarker release. Europace. 2014 Jul;16(7):987-93. doi: 10.1093/europace/eut400. Epub 2014 Jan 19.
PubMed 24446511Yanagisawa S, Inden Y, Mizutani Y, Fujii A, Kamikubo Y, Kanzaki Y, Ando M, Funabiki J, Murase Y, Takenaka M, Otake N, Hattori T, Shibata R, Murohara T. Vagal response in cryoballoon ablation of atrial fibrillation and autonomic nervous system: Utility of epicardial adipose tissue location. J Arrhythm. 2017 Aug;33(4):275-282. doi: 10.1016/j.joa.2017.03.001. Epub 2017 Apr 24.
PubMed 28765757Kellogg DL Jr, Zhao JL, Coey U, Green JV. Acetylcholine-induced vasodilation is mediated by nitric oxide and prostaglandins in human skin. J Appl Physiol (1985). 2005 Feb;98(2):629-32. doi: 10.1152/japplphysiol.00728.2004.
PubMed 15649880Sun L, Dong JZ, DU X, Bai R, Li S, Salim M, Ma CS. Prophylactic Atropine Administration Prevents Vasovagal Response Induced by Cryoballoon Ablation in Patients with Atrial Fibrillation. Pacing Clin Electrophysiol. 2017 May;40(5):551-558. doi: 10.1111/pace.13072. Epub 2017 Apr 25.
PubMed 28295425Kuck KH, Furnkranz A, Chun KR, Metzner A, Ouyang F, Schluter M, Elvan A, Lim HW, Kueffer FJ, Arentz T, Albenque JP, Tondo C, Kuhne M, Sticherling C, Brugada J; FIRE AND ICE Investigators. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. 2016 Oct 7;37(38):2858-2865. doi: 10.1093/eurheartj/ehw285. Epub 2016 Jul 5.
PubMed 27381589Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.
PubMed 27042964Kampaktsis PN, Oikonomou EK, Y Choi D, Cheung JW. Efficacy of ganglionated plexi ablation in addition to pulmonary vein isolation for paroxysmal versus persistent atrial fibrillation: a meta-analysis of randomized controlled clinical trials. J Interv Card Electrophysiol. 2017 Dec;50(3):253-260. doi: 10.1007/s10840-017-0285-z. Epub 2017 Sep 8.
PubMed 28887742
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Release of Acetylcholine From the Autonomic Ganglionated Plexus: a Proposed Mechanism of Induced Hypotension During the Thaw Phase of Cryoballon Pulmonary Vein Ablation (GP RESPONSE Study)
- ClinicalTrials.gov ID
- NCT03636100
- Acronym / sponsor ID
- GP Response
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Catheter ablation, Cryoballon ablation, Acetylcholine, Ganglionated plexus, Pulmonary veins, Pulmonary vein isolation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: After enrollment of half the subjects, the trial was unlikely to yield results
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Saint Luke's Health SystemUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 11 Oct 2019 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 17 Aug 2018 (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.
Determine whether the presence of acetylcholine in the systemic circulation, correlates with the hypotensive response observed during the thaw phase of cryoballoon ablation.
Detailed description
This will be a two-phase (feasibility and primary study phases), prospective observational study with pulmonary vein ablation applications during which a hypotensive response is not observed serving as within-subject controls. A total of 14 patients age 18-80 with atrial fibrillation undergoing first time cryoballoon ablation will be enrolled. Exclusion criteria are any prior left atrial ablation or cardiac surgery, a hemoglobin level of < 12.0 g/dL, or refusal or inability to provide informed consent.
The ablation procedure will be carried out per routine clinical practice by one operator. Two cryoballoon applications targeting 180 seconds per application will be performed per vein. Applications may be abbreviated at the discretion of the operator for indications such as balloon temperatures reaching the mid -50s C, esophageal temperatures approaching 20 C, or a decrease in diaphragmatic movement during phrenic nerve pacing. Application times may be extended to 200 to 240 seconds, also at the discretion of the operator, if within-freeze target temperatures (such as -30 C by 30 seconds or -40 C by 60 seconds) are not met.
A hypotensive response will be defined as a transient ≥ 20% decrease in systolic blood pressure from baseline (start of thaw) during the thaw phase and up to 60 seconds post-end of thaw (balloon deflation). A partial hypotensive response will be defined as a transient 10-19% decrease in systolic blood pressure. For all patients, the time from the end of the cryoballoon freeze to the end of the thaw, to the onset of the hypotensive response, and to blood pressure recovery within 10% of baseline will be recorded. Blood pressure and heart rate will be recorded at each time point. For the first 4 patients (phase I), blood samples of 2-3mL each will be drawn from the mid-right atrium at baseline and then at 30, 60 and 90 seconds after the end of each cryoballoon freeze application. Samples will also be drawn at onset of hypotension and 30 seconds later (superseding the drawing of other samples in the first 90 seconds post-end of freeze), and at blood pressure recovery. Samples will be drawn within 10 seconds of each specified time point; or will not be obtained and will be marked as a missing data point. If more than 20% of the specified data are missing for a given subject, that subject will be excluded from analysis. The samples will then be run on a commercially available 96-well colorimetric assay kit by Cell Biolabs Inc (catalog number STA-603) to assay for acetylcholine.
If the first phase of the study demonstrates the presence of acetylcholine at one or more time points during the thaw phase of 20% or more of cryoballoon applications during which a hypotensive response is observed, the study will proceed to phase 2. The results will be used to determine the optimal time point(s) at which to obtain samples during the second phase of the study (remaining 10 patients), with an anticipated need for 2-4 samples per cryoballoon application, one at start of thaw, another at a determined time point, and when there is a hypotensive response at the onset of hypotension and at blood pressure recovery. An interim report will be produced detailing the observations of phase 1 and specifying the plan for obtaining samples in phase 2.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A total of 14 patients age 18-80 with atrial fibrillation undergoing first time cryoballoon ablation will be enrolled.
Key inclusion criteria (2 listed)
- patients with atrial fibrillation undergoing first time cryoballoon ablation
- age 18-80
Key exclusion criteria (3 listed)
- any prior left atrial ablation or cardiac surgery
- hemoglobin level of <12.0 g/dL
- refusal or inability to provide informed consent
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 |
|---|---|---|
| Cryoballoon ablationCryoballoon ablation using standard equipment and techniques | Device | – |
Primary outcome
Individual acetylcholine levels
Time frame: 1 day
With each subject serving as their own control, acetylcholine levels between ablation applications will be compared followed by a hypotensive response vs those that are not using paired T-tests.
1 secondary outcome
Group acetylcholine levels
Time frame: 1 day
Results and safety
The study was stopped early (reason given: After enrollment of half the subjects, the trial was unlikely to yield results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Background: PubMed 24763464Andrade J, Khairy P, Dobrev D, Nattel S. The clinical profile and pathophysiology of atrial fibrillation: relationships among clinical features, epidemiology, and mechanisms. Circ Res. 2014 Apr 25;114(9):1453-68. doi: 10.1161/CIRCRESAHA.114.303211.
- Background: PubMed 20801856Kojodjojo P, O'Neill MD, Lim PB, Malcolm-Lawes L, Whinnett ZI, Salukhe TV, Linton NW, Lefroy D, Mason A, Wright I, Peters NS, Kanagaratnam P, Davies DW. Pulmonary venous isolation by antral ablation with a large cryoballoon for treatment of paroxysmal and persistent atrial fibrillation: medium-term outcomes and non-randomised comparison with pulmonary venous isolation by radiofrequency ablation. Heart. 2010 Sep;96(17):1379-84. doi: 10.1136/hrt.2009.192419.
- Background: PubMed 19959140Nakagawa H, Scherlag BJ, Patterson E, Ikeda A, Lockwood D, Jackman WM. Pathophysiologic basis of autonomic ganglionated plexus ablation in patients with atrial fibrillation. Heart Rhythm. 2009 Dec;6(12 Suppl):S26-34. doi: 10.1016/j.hrthm.2009.07.029. Epub 2009 Oct 24.
- Background: PubMed 18936041Ketels S, Houben R, Van Beeumen K, Tavernier R, Duytschaever M. Incidence, timing, and characteristics of acute changes in heart rate during ongoing circumferential pulmonary vein isolation. Europace. 2008 Dec;10(12):1406-14. doi: 10.1093/europace/eun287. Epub 2008 Oct 19.
- Background: PubMed 27243034Peyrol M, Barraud J, Koutbi L, Maille B, Trevisan L, Martinez E, Levy S, Paganelli F, Franceschi F. Vagal Reactions during Cryoballoon-Based Pulmonary Vein Isolation: A Clue for Autonomic Nervous System Modulation? Biomed Res Int. 2016;2016:7286074. doi: 10.1155/2016/7286074. Epub 2016 May 3.
- Background: PubMed 26767424Lemery R. Bradycardia with cooling and cryo: A reminder of the autonomic effects of cold stimuli on the heart. Heart Rhythm. 2016 May;13(5):1018-1019. doi: 10.1016/j.hrthm.2015.12.049. Epub 2016 Jan 6. No abstract available.
- Background: PubMed 24446511Bordignon S, Furnkranz A, Dugo D, Perrotta L, Gunawardene M, Bode F, Klemt A, Nowak B, Schulte-Hahn B, Schmidt B, Chun KR. Improved lesion formation using the novel 28 mm cryoballoon in atrial fibrillation ablation: analysis of biomarker release. Europace. 2014 Jul;16(7):987-93. doi: 10.1093/europace/eut400. Epub 2014 Jan 19.
- Background: PubMed 28765757Yanagisawa S, Inden Y, Mizutani Y, Fujii A, Kamikubo Y, Kanzaki Y, Ando M, Funabiki J, Murase Y, Takenaka M, Otake N, Hattori T, Shibata R, Murohara T. Vagal response in cryoballoon ablation of atrial fibrillation and autonomic nervous system: Utility of epicardial adipose tissue location. J Arrhythm. 2017 Aug;33(4):275-282. doi: 10.1016/j.joa.2017.03.001. Epub 2017 Apr 24.
- Background: PubMed 15649880Kellogg DL Jr, Zhao JL, Coey U, Green JV. Acetylcholine-induced vasodilation is mediated by nitric oxide and prostaglandins in human skin. J Appl Physiol (1985). 2005 Feb;98(2):629-32. doi: 10.1152/japplphysiol.00728.2004.
- Background: PubMed 28295425Sun L, Dong JZ, DU X, Bai R, Li S, Salim M, Ma CS. Prophylactic Atropine Administration Prevents Vasovagal Response Induced by Cryoballoon Ablation in Patients with Atrial Fibrillation. Pacing Clin Electrophysiol. 2017 May;40(5):551-558. doi: 10.1111/pace.13072. Epub 2017 Apr 25.
- Background: PubMed 27381589Kuck KH, Furnkranz A, Chun KR, Metzner A, Ouyang F, Schluter M, Elvan A, Lim HW, Kueffer FJ, Arentz T, Albenque JP, Tondo C, Kuhne M, Sticherling C, Brugada J; FIRE AND ICE Investigators. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. 2016 Oct 7;37(38):2858-2865. doi: 10.1093/eurheartj/ehw285. Epub 2016 Jul 5.
- Background: PubMed 27042964Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Saint Luke's Health System at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was stopped early (reason given: After enrollment of half the subjects, the trial was unlikely to yield results). Results are not available in the source record.
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?
Individual acetylcholine levels (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 NCT03636100, which also lists 13 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 Oct 2021.