Atrial FibrillationPhase 2PAPERSNCT06731595
Post-Ablation Pericarditis Reduction Study (PAPERS)
A Phase 2 study testing Colchicine in people with Atrial Fibrillation and Catheter Ablation, run by St. Vincent Cardiovascular Research Institute at 1 site in United States.
Trial summary
There has not been a prospective, randomized controlled trial of colchicine to reduce post-AF ablation pericarditis in an era of newer AF ablation techniques. The hypothesis is that an empiric pre and post AF ablation treatment protocol with colchicine may reduce the incidence and symptom severity of post-AF ablation… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Catheter Ablation, Pericarditis
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2021to 1 Oct 2022
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients >/= 18 undergoing atrial fibrillation ablation
Who cannot join
- Patients unable to receive or tolerate colchicine
- Pregnant or lactating women
- Concomitant use of drugs interacting with colchicine (including: cyclosporin, ranolazine, tacrolimus, clarithromycin, indinavir, itraconazole, ketoconazole, nefazadone, ritonavir, saquinavir, suboxone, telithromycin, erythromycin, fluconazole, verapamil, diltiazem, or more than 1 glass grapefruit juice daily)
- Severe renal impairment (CrCl < 30 mL/min)
- Severe hepatic impairment (ALT/AST greater than 5x ULN or clinical cirrhosis)
- Ongoing current use of colchicine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ascension St Vincent Hospital
Indianapolis, Indiana, 46260
About this study
Official title: Post-Ablation Pericarditis Reduction Study
There has not been a prospective, randomized controlled trial of colchicine to reduce post-AF ablation pericarditis in an era of newer AF ablation techniques. The hypothesis is that an empiric pre and post AF ablation treatment protocol with colchicine may reduce the incidence and symptom severity of post-AF ablation related pericarditis. Thus, the goal of this study is to
- Identify the incidence of post-AF ablation related pericarditis in patients undergoing ablation via high power, short duration strategy (shorter total RF time, but increased stability due to steerable catheters and possible difference from resistive vs conductive heating).
- Identify potential differences in patients undergoing PVI only versus PVI + additional ablation
- Identify whether patients on who are already on anti-inflammatories such as ASA or statins have a lower incidence than those without
- Determine if an empiric treatment strategy with colchicine (for 7 days post ablation) reduces the incidence of post-operative AF
Read the detailed description
This study will be a prospective, randomized controlled study of 248 patients presenting to the electrophysiology lab at Ascension St. Vincent (Indianapolis, IN) and Ascension Sacred Heart (Pensacola, FL) for atrial fibrillation ablation. Cases will be randomized in sequential order.
The control arm will undergo standard of care, whereas the study arm will undergo treatment with colchicine 0.6mg PO BID for 7 days following ablation.
Study variables will consist of
- Patient demographics
- age, gender, comorbidities (HTN, HLD, DM-2, COPD, tobacco use, OSA, CKD, weight in kg, BMI, LVEF, autoimmune inflammatory condition such as RA), type of AF (paroxysmal, persistent, etc.)
- Medical therapy characteristics
- anticoagulation choice, statin present, aspirin present, discontinuation of colchicine due to gastrointestinal distress
- Procedural characteristics o length of procedure, initial vs redo procedure, PVI only versus PVI + additional lines, total RF application time, HPSD vs MPMD approach, #RF applications, Power, Contact force, Impedance
Rates of acute post-operative pericarditis will be compared between the two groups. Subjects will be called by study personnel within 7-14 days to identify any post-ablation symptoms. If a patient develops pericarditis, standard anti-inflammatory therapy will be initiated in those patients regardless of study arm.
The primary outcome will be the development of post-AF ablation pericarditis within 30 days of ablation. This will be ascertained by comprehensive chart review and at the routine post-ablation follow up visit; additionally, there will be a standard telephone survey administered 7-14d after ablation (see instrument). Secondary outcomes will include symptoms, incidence of post-ablation AF recurrence, patient satisfaction using a Likert scale, and other clinical variables.
- Conditions
- Atrial Fibrillation, Catheter Ablation, Pericarditis
- Being tested
- Colchicine
- Medical subject headings
- Atrial Fibrillation, Pericarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Also called colcrys, mitigare
colchicine 0.6mg oral twice daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Usual standard of care post atrial fibrillation ablation. |
| Colchicine | Experimental | 0.6mg colchicine oral twice daily for 7 days. Receives: Drug: Colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Pericarditis
Clinical pericarditis ascertained by comprehensive chart review and a follow up phone call using a survey instrument.
Measured: Postoperative day 30.
Secondary outcomes (2)
Proportion of patients with recurrent Atrial fibrillation
Recurrence of atrial fibrillation post ablation
Measured: Through study completion, an average of 1 year
Median rating of patient satisfaction on a Likert scale, comparing the study group and standard of care group.
Patient satisfaction with ablation and post ablation care, measured on a Likert scale (min 1 and max 5, with 1 being best and 5 being worst) and derived from a telephone survey.
Measured: Postoperative day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start20 May 2021
- Primary completion30 Jan 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Vincent Cardiovascular Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Asenson Sacred Heart - Pensacoloa, FL
- Responsible party
- Principal investigator, Parin Patel, St. Vincent Cardiovascular Research Institute
- Investigators
- Parin J. Patel, MD, Principal investigator, Physician; Board Member, Institutional Review Board; Board Member, Cardiovascular Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731595
- Sponsor's protocol ID
- PAPERS
- Acronym
- PAPERS
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leung YY, Yao Hui LL, Kraus VB. Colchicine--Update on mechanisms of action and therapeutic uses. Semin Arthritis Rheum. 2015 Dec;45(3):341-50. doi: 10.1016/j.semarthrit.2015.06.013. Epub 2015 Jun 26.
PubMed 26228647Imazio M, Bobbio M, Cecchi E, Demarie D, Demichelis B, Pomari F, Moratti M, Gaschino G, Giammaria M, Ghisio A, Belli R, Trinchero R. Colchicine in addition to conventional therapy for acute pericarditis: results of the COlchicine for acute PEricarditis (COPE) trial. Circulation. 2005 Sep 27;112(13):2012-6. doi: 10.1161/CIRCULATIONAHA.105.542738.
PubMed 16186437Imazio M, Brucato A, Ferrazzi P, Pullara A, Adler Y, Barosi A, Caforio AL, Cemin R, Chirillo F, Comoglio C, Cugola D, Cumetti D, Dyrda O, Ferrua S, Finkelstein Y, Flocco R, Gandino A, Hoit B, Innocente F, Maestroni S, Musumeci F, Oh J, Pergolini A, Polizzi V, Ristic A, Simon C, Spodick DH, Tarzia V, Trimboli S, Valenti A, Belli R, Gaita F; COPPS-2 Investigators. Colchicine for prevention of postpericardiotomy syndrome and postoperative atrial fibrillation: the COPPS-2 randomized clinical trial. JAMA. 2014 Sep 10;312(10):1016-23. doi: 10.1001/jama.2014.11026.
PubMed 25172965Tabbalat RA, Alhaddad I, Hammoudeh A, Khader YS, Khalaf HA, Obaidat M, Barakat J. Effect of Low-dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Low Dose Trial. J Int Med Res. 2020 Jul;48(7):300060520939832. doi: 10.1177/0300060520939832.
PubMed 32720823Deftereos S, Giannopoulos G, Kossyvakis C, Efremidis M, Panagopoulou V, Kaoukis A, Raisakis K, Bouras G, Angelidis C, Theodorakis A, Driva M, Doudoumis K, Pyrgakis V, Stefanadis C. Colchicine for prevention of early atrial fibrillation recurrence after pulmonary vein isolation: a randomized controlled study. J Am Coll Cardiol. 2012 Oct 30;60(18):1790-6. doi: 10.1016/j.jacc.2012.07.031. Epub 2012 Oct 3.
PubMed 23040570Deftereos S, Giannopoulos G, Efremidis M, Kossyvakis C, Katsivas A, Panagopoulou V, Papadimitriou C, Karageorgiou S, Doudoumis K, Raisakis K, Kaoukis A, Alexopoulos D, Manolis AS, Stefanadis C, Cleman MW. Colchicine for prevention of atrial fibrillation recurrence after pulmonary vein isolation: mid-term efficacy and effect on quality of life. Heart Rhythm. 2014 Apr;11(4):620-8. doi: 10.1016/j.hrthm.2014.02.002. Epub 2014 Feb 4.
PubMed 24508207Deyell MW, Leather RA, Macle L, Forman J, Khairy P, Zhang R, Ding L, Chakrabarti S, Yeung-Lai-Wah JA, Lane C, Novak PG, Sterns LD, Bennett MT, Laksman ZW, Sikkel MB, Andrade JG. Efficacy and Safety of Same-Day Discharge for Atrial Fibrillation Ablation. JACC Clin Electrophysiol. 2020 Jun;6(6):609-619. doi: 10.1016/j.jacep.2020.02.009. Epub 2020 Apr 29.
PubMed 32553209Ahmed AS, Clark BA, Joshi SA, Nair GV, Olson JA, Padanilam BJ, Patel PJ. Avoiding Bladder Catheters During Atrial Fibrillation Ablation. JACC Clin Electrophysiol. 2020 Feb;6(2):185-190. doi: 10.1016/j.jacep.2019.10.003. Epub 2019 Nov 27.
PubMed 32081221Gilge JL, Ahmed A, Clark BA, Slaten A, Devathu R, Olson JA, Padanilam BJ, Nair GV, Joshi SA, Ravichandran AK, Patel PJ. Left atrial hypertension and the risk of early incident heart failure after atrial fibrillation ablation. J Cardiovasc Electrophysiol. 2021 Feb;32(2):325-332. doi: 10.1111/jce.14829. Epub 2020 Dec 14.
PubMed 33270311
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Ablation Pericarditis Reduction Study
- ClinicalTrials.gov ID
- NCT06731595
- Acronym / sponsor ID
- PAPERS / PAPERS
- Conditions
- Atrial Fibrillation, Catheter Ablation, Pericarditis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- St. Vincent Cardiovascular Research InstituteUniversity, hospital or other
- Collaborators
- Asenson Sacred Heart - Pensacoloa, FL
- Study start
- 20 May 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 12 Dec 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.
There has not been a prospective, randomized controlled trial of colchicine to reduce post-AF ablation pericarditis in an era of newer AF ablation techniques. The hypothesis is that an empiric pre and post AF ablation treatment protocol with colchicine may reduce the incidence and symptom severity of post-AF ablation related pericarditis. Thus, the goal of this study is to
- Identify the incidence of post-AF ablation related pericarditis in patients undergoing ablation via high power, short duration strategy (shorter total RF time, but increased stability due to steerable catheters and possible difference from resistive vs conductive heating).
- Identify potential differences in patients undergoing PVI only versus PVI + additional ablation
- Identify whether patients on who are already on anti-inflammatories such as ASA or statins have a lower incidence than those without
- Determine if an empiric treatment strategy with colchicine (for 7 days post ablation) reduces the incidence of post-operative AF
Detailed description
This study will be a prospective, randomized controlled study of 248 patients presenting to the electrophysiology lab at Ascension St. Vincent (Indianapolis, IN) and Ascension Sacred Heart (Pensacola, FL) for atrial fibrillation ablation. Cases will be randomized in sequential order.
The control arm will undergo standard of care, whereas the study arm will undergo treatment with colchicine 0.6mg PO BID for 7 days following ablation.
Study variables will consist of
- Patient demographics
- age, gender, comorbidities (HTN, HLD, DM-2, COPD, tobacco use, OSA, CKD, weight in kg, BMI, LVEF, autoimmune inflammatory condition such as RA), type of AF (paroxysmal, persistent, etc.)
- Medical therapy characteristics
- anticoagulation choice, statin present, aspirin present, discontinuation of colchicine due to gastrointestinal distress
- Procedural characteristics o length of procedure, initial vs redo procedure, PVI only versus PVI + additional lines, total RF application time, HPSD vs MPMD approach, #RF applications, Power, Contact force, Impedance
Rates of acute post-operative pericarditis will be compared between the two groups. Subjects will be called by study personnel within 7-14 days to identify any post-ablation symptoms. If a patient develops pericarditis, standard anti-inflammatory therapy will be initiated in those patients regardless of study arm.
The primary outcome will be the development of post-AF ablation pericarditis within 30 days of ablation. This will be ascertained by comprehensive chart review and at the routine post-ablation follow up visit; additionally, there will be a standard telephone survey administered 7-14d after ablation (see instrument). Secondary outcomes will include symptoms, incidence of post-ablation AF recurrence, patient satisfaction using a Likert scale, and other clinical variables.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Usual standard of care post atrial fibrillation ablation. |
| Colchicine | Experimental | Drug: Colchicine0.6mg colchicine oral twice daily for 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients >/= 18 undergoing atrial fibrillation ablation
Key exclusion criteria (6 listed)
- Patients unable to receive or tolerate colchicine
- Pregnant or lactating women
- Concomitant use of drugs interacting with colchicine (including: cyclosporin, ranolazine, tacrolimus, clarithromycin, indinavir, itraconazole, ketoconazole, nefazadone, ritonavir, saquinavir, suboxone, telithromycin, erythromycin, fluconazole, verapamil, diltiazem, or more than 1 glass grapefruit juice daily)
- Severe renal impairment (CrCl < 30 mL/min)
- Severe hepatic impairment (ALT/AST greater than 5x ULN or clinical cirrhosis)
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 |
|---|---|---|
| ColchicineAlso: colcrys, mitigarecolchicine 0.6mg oral twice daily for 7 days | Drug | Colchicine |
Primary outcome
Proportion of patients with Pericarditis
Time frame: Postoperative day 30.
Clinical pericarditis ascertained by comprehensive chart review and a follow up phone call using a survey instrument.
2 secondary outcomes
Proportion of patients with recurrent Atrial fibrillation
Time frame: Through study completion, an average of 1 year
Median rating of patient satisfaction on a Likert scale, comparing the study group and standard of care group.
Time frame: Postoperative day 14
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 12 Dec 2024.
- Results publication: PubMed 26228647Leung YY, Yao Hui LL, Kraus VB. Colchicine--Update on mechanisms of action and therapeutic uses. Semin Arthritis Rheum. 2015 Dec;45(3):341-50. doi: 10.1016/j.semarthrit.2015.06.013. Epub 2015 Jun 26.
- Results publication: PubMed 16186437Imazio M, Bobbio M, Cecchi E, Demarie D, Demichelis B, Pomari F, Moratti M, Gaschino G, Giammaria M, Ghisio A, Belli R, Trinchero R. Colchicine in addition to conventional therapy for acute pericarditis: results of the COlchicine for acute PEricarditis (COPE) trial. Circulation. 2005 Sep 27;112(13):2012-6. doi: 10.1161/CIRCULATIONAHA.105.542738.
- Results publication: PubMed 25172965Imazio M, Brucato A, Ferrazzi P, Pullara A, Adler Y, Barosi A, Caforio AL, Cemin R, Chirillo F, Comoglio C, Cugola D, Cumetti D, Dyrda O, Ferrua S, Finkelstein Y, Flocco R, Gandino A, Hoit B, Innocente F, Maestroni S, Musumeci F, Oh J, Pergolini A, Polizzi V, Ristic A, Simon C, Spodick DH, Tarzia V, Trimboli S, Valenti A, Belli R, Gaita F; COPPS-2 Investigators. Colchicine for prevention of postpericardiotomy syndrome and postoperative atrial fibrillation: the COPPS-2 randomized clinical trial. JAMA. 2014 Sep 10;312(10):1016-23. doi: 10.1001/jama.2014.11026.
- Results publication: PubMed 32720823Tabbalat RA, Alhaddad I, Hammoudeh A, Khader YS, Khalaf HA, Obaidat M, Barakat J. Effect of Low-dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Low Dose Trial. J Int Med Res. 2020 Jul;48(7):300060520939832. doi: 10.1177/0300060520939832.
- Results publication: PubMed 23040570Deftereos S, Giannopoulos G, Kossyvakis C, Efremidis M, Panagopoulou V, Kaoukis A, Raisakis K, Bouras G, Angelidis C, Theodorakis A, Driva M, Doudoumis K, Pyrgakis V, Stefanadis C. Colchicine for prevention of early atrial fibrillation recurrence after pulmonary vein isolation: a randomized controlled study. J Am Coll Cardiol. 2012 Oct 30;60(18):1790-6. doi: 10.1016/j.jacc.2012.07.031. Epub 2012 Oct 3.
- Results publication: PubMed 24508207Deftereos S, Giannopoulos G, Efremidis M, Kossyvakis C, Katsivas A, Panagopoulou V, Papadimitriou C, Karageorgiou S, Doudoumis K, Raisakis K, Kaoukis A, Alexopoulos D, Manolis AS, Stefanadis C, Cleman MW. Colchicine for prevention of atrial fibrillation recurrence after pulmonary vein isolation: mid-term efficacy and effect on quality of life. Heart Rhythm. 2014 Apr;11(4):620-8. doi: 10.1016/j.hrthm.2014.02.002. Epub 2014 Feb 4.
- Results publication: PubMed 32553209Deyell MW, Leather RA, Macle L, Forman J, Khairy P, Zhang R, Ding L, Chakrabarti S, Yeung-Lai-Wah JA, Lane C, Novak PG, Sterns LD, Bennett MT, Laksman ZW, Sikkel MB, Andrade JG. Efficacy and Safety of Same-Day Discharge for Atrial Fibrillation Ablation. JACC Clin Electrophysiol. 2020 Jun;6(6):609-619. doi: 10.1016/j.jacep.2020.02.009. Epub 2020 Apr 29.
- Results publication: PubMed 32081221Ahmed AS, Clark BA, Joshi SA, Nair GV, Olson JA, Padanilam BJ, Patel PJ. Avoiding Bladder Catheters During Atrial Fibrillation Ablation. JACC Clin Electrophysiol. 2020 Feb;6(2):185-190. doi: 10.1016/j.jacep.2019.10.003. Epub 2019 Nov 27.
- Results publication: PubMed 33270311Gilge JL, Ahmed A, Clark BA, Slaten A, Devathu R, Olson JA, Padanilam BJ, Nair GV, Joshi SA, Ravichandran AK, Patel PJ. Left atrial hypertension and the risk of early incident heart failure after atrial fibrillation ablation. J Cardiovasc Electrophysiol. 2021 Feb;32(2):325-332. doi: 10.1111/jce.14829. Epub 2020 Dec 14.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruitingObservational study
FARAPULSE™ Pulsed Field Ablation System
Paroxysmal AF
Not yet recruiting
Mazdutide for Reducing Atrial Fibrillation Recurrence After Catheter Ablation in Obese Patients
Atrial Fibrillation (AF), Ablation Treatment
Recruiting
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Not yet recruiting
Mobile Clinic-Supported, Village Doctor-Led Screening and Integrated Care for Atrial Fibrillation and Heart Failure Comorbidity in Rural China (MOVE-AF HF)
Atrial Fibrillation (AF), Heart Failure
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.
Parin J. Patel, MD principal investigator
Physician; Board Member, Institutional Review Board; Board Member, Cardiovascular Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchicine in people with Atrial Fibrillation and Catheter Ablation, run by St. Vincent Cardiovascular Research Institute 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 1 inclusion and 6 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 12 Dec 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proportion of patients with Pericarditis (time frame: Postoperative day 30.). 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 NCT06731595, which also lists 9 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 12 Dec 2024.