Atrial FibrillationPhase 4NCT03432663
Time-dependent Amiodarone Treatment in Atrial Fibrillation
A Phase 4 study testing Intravenous amiodarone(1) and Intravenous amiodarone(2) in people with Atrial Fibrillation, run by Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud at 1 site in Mexico.
Trial summary
Sixty consecutive emergency patients with newly diagnosed Atrial Fibrillation were randomized into two groups. The first received intravenous amiodarone infusions continuously for 24 hours; the second received Amiodarone until sinus rhythms was reached or for up to 72 hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Intravenous amiodarone(1) and Intravenous amiodarone(2)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2008to 30 Nov 2009
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old
- Emergency patients
- First symptomatic episodes of Atrial Fibrillation
Who cannot join
- Hemodynamic instability,
- Previous use of antiarrhythmic drugs
- Use of digoxin seven or fewer days prior to the study
- Active thyroid disease
- Known adverse reactions to amiodarone
- Other ventricular arrhythmias
Show all 14Show fewer
- Contraindications for anticoagulation
- Acute renal failure
- Chronic liver disease
- Transaminase levels that were twice the normal levels
- Acute pulmonary edema
- Uncontrolled hypertension (> 180/110 mmHg)
- Unstable angina
- Patients who were pregnant and/or breast feeding
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario "Dr. José Eleuterio González". Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, 64460
About this study
Official title: Using Time-dependent Intravenous Infusions of Amiodarone for Conversions to Sinus Rhythms in Patients With Paroxysmal Atrial Fibrillation
Sixty consecutive emergency patients with newly diagnosed Atrial Fibrillation were randomized into two groups. The first received intravenous amiodarone infusions continuously for 24 hours; the second received Amiodarone until sinus rhythms was reached or for up to 72 hours.
The efficacy and safety of administering intravenous infusions of amiodarone for up to 72 hours were investigated and compared to the efficacy and safety of administering a standard 24 hours infusion of amiodarone. Specifically, the use of up to 72 hours infusions was considered as a new strategy to improve rates of conversion to sinus rhythm without altering the safety profile of the drug.
Read the detailed description
An open randomized clinical trial was conducted that included 60 emergency adult patients who were candidates for drug cardioversion after first symptomatic episodes of AF.
The patients were randomized in equal proportions and sequentially placed in one of two treatment groups; no patient knew to which group he or she belonged. The first group received intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg until 24 hours was reached. The second group received intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg every 24 hours for up to 72 hours.
All patients were continuously monitored using electrocardiograms, and echocardiograms were performed within 24 hours after the randomized trial began. The exact time of each patient's cardioversion was documented. In addition, general laboratory tests, lipid profiles, thyroid profiles and chest X-rays were obtained for all patients.
A sample size of 30 subjects in each group was calculated. A conversion rate of 60% was assumed, according to literature, and an estimated increase to 90% was assumed for the experimental group to find differences with a power of 0.8 and an alpha error of 0.05.
The primary goal was to obtain was a sinus rhythm conversion rate. The secondary goal was to obtain a combined complication rate by noting various complications in the patients, such as phlebitis, symptomatic hypotension that required vasopressors, bradycardia, nausea, vomiting and any organ embolism.
- Conditions
- Atrial Fibrillation
- Being tested
- Intravenous amiodarone(1), Intravenous amiodarone(2)
- Keywords
- Atrial Fibrillation, Intravenous Amiodarone, Drug safety profile, Chemical cardioversion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous amiodarone(1)Drug
Also called 24 hour amiodarone
Intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg until 24 h was reached
Intravenous amiodarone(2)Drug
Also called 72 hour amiodarone
Intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg every 24 h for up to 72 h or until sinus rhythm was reached
| Study group | Role | What they receive |
|---|---|---|
| 24h infusion | Experimental | Intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg until 24 h was reached Intravenous amiodarone (1) Receives: Drug: Intravenous amiodarone(1) |
| 72h infusion | Experimental | Intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg every 24 h for up to 72 h or until sinus rhythm was reached Intravenous amiodarone (2) Receives: Drug: Intravenous amiodarone(2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtain a continuous sinus rhythm
Monitoring using continuous telemetry.
Measured: 72 hours
Secondary outcomes (1)
Complication rate of continuous amiodarone intravenous infusion
Obtain a combined complication rate by noting various complications in the patients, such as phlebitis, symptomatic hypotension that required vasopressors, bradycardia, nausea, vomiting and any organ embolism.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start1 Aug 2008
- Primary completion30 Nov 2009
- Study completion30 Nov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 60 emergency adult patients who were candidates for drug cardioversion after first symptomatic episodes of Atrial fibrillation to either (1)24 hour continuous infusion or (2)72 hours continuous intravenous Amiodarone or until sinus rhythms was reached.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis A Sanchez-Trujillo, MD, Principal investigator, Escuela de Medicina y Ciencias de la Salud. Tecnológico de Monterrey. Monterrey. México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432663
- Sponsor's protocol ID
- 2017-LS002
- Status last verified
- Feb 2018
- First submitted
- 29 Jan 2018
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cotter G, Blatt A, Kaluski E, Metzkor-Cotter E, Koren M, Litinski I, Simantov R, Moshkovitz Y, Zaidenstein R, Peleg E, Vered Z, Golik A. Conversion of recent onset paroxysmal atrial fibrillation to normal sinus rhythm: the effect of no treatment and high-dose amiodarone. A randomized, placebo-controlled study. Eur Heart J. 1999 Dec;20(24):1833-42. doi: 10.1053/euhj.1999.1747.
PubMed 10581142Snow V, Weiss KB, LeFevre M, McNamara R, Bass E, Green LA, Michl K, Owens DK, Susman J, Allen DI, Mottur-Pilson C; AAFP Panel on Atrial Fibrillation; ACP Panel on Atrial Fibrillation. Management of newly detected atrial fibrillation: a clinical practice guideline from the American Academy of Family Physicians and the American College of Physicians. Ann Intern Med. 2003 Dec 16;139(12):1009-17. doi: 10.7326/0003-4819-139-12-200312160-00011.
PubMed 14678921Joseph AP, Ward MR. A prospective, randomized controlled trial comparing the efficacy and safety of sotalol, amiodarone, and digoxin for the reversion of new-onset atrial fibrillation. Ann Emerg Med. 2000 Jul;36(1):1-9. doi: 10.1067/mem.2000.107655.
PubMed 10874228Tuseth V, Jaatun HJ, Dickstein K. Amiodarone infusion in the treatment of acute atrial fibrillation or flutter: high versus low dose treatment. Heart. 2005 Jul;91(7):964-5. doi: 10.1136/hrt.2004.049171. No abstract available.
PubMed 15958375Waldo AL. Management of atrial fibrillation: the need for AFFIRMative action. AFFIRM investigators. Atrial Fibrillation Follow-up Investigation of Rhythm Management. Am J Cardiol. 1999 Sep 15;84(6):698-700. doi: 10.1016/s0002-9149(99)00419-1. No abstract available.
PubMed 10498142Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, Kellen JC, Greene HL, Mickel MC, Dalquist JE, Corley SD; Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Investigators. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med. 2002 Dec 5;347(23):1825-33. doi: 10.1056/NEJMoa021328.
PubMed 12466506Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.
PubMed 11343485Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946.
PubMed 9737513Vaziri SM, Larson MG, Benjamin EJ, Levy D. Echocardiographic predictors of nonrheumatic atrial fibrillation. The Framingham Heart Study. Circulation. 1994 Feb;89(2):724-30. doi: 10.1161/01.cir.89.2.724.
PubMed 8313561Kumana CR, Cheung BM, Cheung GT, Ovedal T, Pederson B, Lauder IJ. Rhythm vs. rate control of atrial fibrillation meta-analysed by number needed to treat. Br J Clin Pharmacol. 2005 Oct;60(4):347-54. doi: 10.1111/j.1365-2125.2005.02449.x.
PubMed 16187966Lim HS, Hamaad A, Lip GY. Clinical review: clinical management of atrial fibrillation - rate control versus rhythm control. Crit Care. 2004 Aug;8(4):271-9. doi: 10.1186/cc2827. Epub 2004 Feb 19.
PubMed 15312210Chevalier P, Durand-Dubief A, Burri H, Cucherat M, Kirkorian G, Touboul P. Amiodarone versus placebo and class Ic drugs for cardioversion of recent-onset atrial fibrillation: a meta-analysis. J Am Coll Cardiol. 2003 Jan 15;41(2):255-62. doi: 10.1016/s0735-1097(02)02705-5.
PubMed 12535819Hauser TH, Pinto DS, Josephson ME, Zimetbaum P. Early recurrence of arrhythmia in patients taking amiodarone or class 1C agents for treatment of atrial fibrillation or atrial flutter. Am J Cardiol. 2004 May 1;93(9):1173-6. doi: 10.1016/j.amjcard.2004.01.051.
PubMed 15110217Khan IA, Mehta NJ, Gowda RM. Amiodarone for pharmacological cardioversion of recent-onset atrial fibrillation. Int J Cardiol. 2003 Jun;89(2-3):239-48. doi: 10.1016/s0167-5273(02)00477-1.
PubMed 12767548Hagens VE, Van Gelder IC, Crijns HJ; RAte Control Versus Electrical Cardioversion Of Persistent Atrial Fibrillation (RACE) Study Group. The RACE study in perspective of randomized studies on management of persistent atrial fibrillation. Card Electrophysiol Rev. 2003 Jun;7(2):118-21. doi: 10.1023/a:1027439430017.
PubMed 14618033
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Time-dependent Intravenous Infusions of Amiodarone for Conversions to Sinus Rhythms in Patients With Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03432663
- Acronym / sponsor ID
- 2017-LS002
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Intravenous Amiodarone, Drug safety profile, Chemical cardioversion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec SaludUniversity, hospital or other
- Study start
- 1 Aug 2008 (actual)
- Primary completion
- 30 Nov 2009 (actual)
- Study completion
- 30 Nov 2009 (actual)
- First posted
- 14 Feb 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.
Sixty consecutive emergency patients with newly diagnosed Atrial Fibrillation were randomized into two groups. The first received intravenous amiodarone infusions continuously for 24 hours; the second received Amiodarone until sinus rhythms was reached or for up to 72 hours.
The efficacy and safety of administering intravenous infusions of amiodarone for up to 72 hours were investigated and compared to the efficacy and safety of administering a standard 24 hours infusion of amiodarone. Specifically, the use of up to 72 hours infusions was considered as a new strategy to improve rates of conversion to sinus rhythm without altering the safety profile of the drug.
Detailed description
An open randomized clinical trial was conducted that included 60 emergency adult patients who were candidates for drug cardioversion after first symptomatic episodes of AF.
The patients were randomized in equal proportions and sequentially placed in one of two treatment groups; no patient knew to which group he or she belonged. The first group received intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg until 24 hours was reached. The second group received intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg every 24 hours for up to 72 hours.
All patients were continuously monitored using electrocardiograms, and echocardiograms were performed within 24 hours after the randomized trial began. The exact time of each patient's cardioversion was documented. In addition, general laboratory tests, lipid profiles, thyroid profiles and chest X-rays were obtained for all patients.
A sample size of 30 subjects in each group was calculated. A conversion rate of 60% was assumed, according to literature, and an estimated increase to 90% was assumed for the experimental group to find differences with a power of 0.8 and an alpha error of 0.05.
The primary goal was to obtain was a sinus rhythm conversion rate. The secondary goal was to obtain a combined complication rate by noting various complications in the patients, such as phlebitis, symptomatic hypotension that required vasopressors, bradycardia, nausea, vomiting and any organ embolism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 60 emergency adult patients who were candidates for drug cardioversion after first symptomatic episodes of Atrial fibrillation to either (1)24 hour continuous infusion or (2)72 hours continuous intravenous Amiodarone or until sinus rhythms was reached.
| Arm | Type | Receives |
|---|---|---|
| 24h infusion | Experimental | Drug: Intravenous amiodarone(1)Intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg until 24 h was reached Intravenous amiodarone (1) |
| 72h infusion | Experimental | Drug: Intravenous amiodarone(2)Intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg every 24 h for up to 72 h or until sinus rhythm was reached Intravenous amiodarone (2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years old
- Emergency patients
- First symptomatic episodes of Atrial Fibrillation
Key exclusion criteria (14 listed)
- Hemodynamic instability,
- Previous use of antiarrhythmic drugs
- Use of digoxin seven or fewer days prior to the study
- Active thyroid disease
- Known adverse reactions to amiodarone
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 |
|---|---|---|
| Intravenous amiodarone(1)Also: 24 hour amiodaroneIntravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg until 24 h was reached | Drug | 24h infusion |
| Intravenous amiodarone(2)Also: 72 hour amiodaroneIntravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg every 24 h for up to 72 h or until sinus rhythm was reached | Drug | 72h infusion |
Primary outcome
Obtain a continuous sinus rhythm
Time frame: 72 hours
Monitoring using continuous telemetry.
1 secondary outcome
Complication rate of continuous amiodarone intravenous infusion
Time frame: 72 hours
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 14 Feb 2018.
- Background: PubMed 10581142Cotter G, Blatt A, Kaluski E, Metzkor-Cotter E, Koren M, Litinski I, Simantov R, Moshkovitz Y, Zaidenstein R, Peleg E, Vered Z, Golik A. Conversion of recent onset paroxysmal atrial fibrillation to normal sinus rhythm: the effect of no treatment and high-dose amiodarone. A randomized, placebo-controlled study. Eur Heart J. 1999 Dec;20(24):1833-42. doi: 10.1053/euhj.1999.1747.
- Background: PubMed 14678921Snow V, Weiss KB, LeFevre M, McNamara R, Bass E, Green LA, Michl K, Owens DK, Susman J, Allen DI, Mottur-Pilson C; AAFP Panel on Atrial Fibrillation; ACP Panel on Atrial Fibrillation. Management of newly detected atrial fibrillation: a clinical practice guideline from the American Academy of Family Physicians and the American College of Physicians. Ann Intern Med. 2003 Dec 16;139(12):1009-17. doi: 10.7326/0003-4819-139-12-200312160-00011.
- Background: PubMed 10874228Joseph AP, Ward MR. A prospective, randomized controlled trial comparing the efficacy and safety of sotalol, amiodarone, and digoxin for the reversion of new-onset atrial fibrillation. Ann Emerg Med. 2000 Jul;36(1):1-9. doi: 10.1067/mem.2000.107655.
- Background: PubMed 15958375Tuseth V, Jaatun HJ, Dickstein K. Amiodarone infusion in the treatment of acute atrial fibrillation or flutter: high versus low dose treatment. Heart. 2005 Jul;91(7):964-5. doi: 10.1136/hrt.2004.049171. No abstract available.
- Background: PubMed 10498142Waldo AL. Management of atrial fibrillation: the need for AFFIRMative action. AFFIRM investigators. Atrial Fibrillation Follow-up Investigation of Rhythm Management. Am J Cardiol. 1999 Sep 15;84(6):698-700. doi: 10.1016/s0002-9149(99)00419-1. No abstract available.
- Background: PubMed 12466506Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, Kellen JC, Greene HL, Mickel MC, Dalquist JE, Corley SD; Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Investigators. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med. 2002 Dec 5;347(23):1825-33. doi: 10.1056/NEJMoa021328.
- Background: PubMed 11343485Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.
- Background: PubMed 9737513Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946.
- Background: PubMed 8313561Vaziri SM, Larson MG, Benjamin EJ, Levy D. Echocardiographic predictors of nonrheumatic atrial fibrillation. The Framingham Heart Study. Circulation. 1994 Feb;89(2):724-30. doi: 10.1161/01.cir.89.2.724.
- Background: PubMed 16187966Kumana CR, Cheung BM, Cheung GT, Ovedal T, Pederson B, Lauder IJ. Rhythm vs. rate control of atrial fibrillation meta-analysed by number needed to treat. Br J Clin Pharmacol. 2005 Oct;60(4):347-54. doi: 10.1111/j.1365-2125.2005.02449.x.
- Background: PubMed 15312210Lim HS, Hamaad A, Lip GY. Clinical review: clinical management of atrial fibrillation - rate control versus rhythm control. Crit Care. 2004 Aug;8(4):271-9. doi: 10.1186/cc2827. Epub 2004 Feb 19.
- Background: PubMed 12535819Chevalier P, Durand-Dubief A, Burri H, Cucherat M, Kirkorian G, Touboul P. Amiodarone versus placebo and class Ic drugs for cardioversion of recent-onset atrial fibrillation: a meta-analysis. J Am Coll Cardiol. 2003 Jan 15;41(2):255-62. doi: 10.1016/s0735-1097(02)02705-5.
- Individual participant dataSharing planned: Undecided
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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.
Luis A Sanchez-Trujillo, MD principal investigator
Escuela de Medicina y Ciencias de la Salud. Tecnológico de Monterrey. Monterrey. México
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous amiodarone(1) and Intravenous amiodarone(2) in people with Atrial Fibrillation, run by Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud at 1 site in Mexico.
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 3 inclusion and 14 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 14 Feb 2018. 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 Mexico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Obtain a continuous sinus rhythm (time frame: 72 hours). 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 NCT03432663, which also lists 42 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 14 Feb 2018.