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Atrial Fibrillation New OnsetNCT05780320

A Pharmaco-surgical Approach to Reduce Postoperative Atrial Fibrillation After Cardiac Surgery

An observational study of Atrial Fibrillation New Onset, run by Massachusetts General Hospital at 1 site in United States.

Completed

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

Official record
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Trial summary

Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery with an estimated incidence around 35%. It has been found to be an independent predictor of 30-day and 6-month mortality, stroke, renal failure, respiratory failure, and need for permanent pacemaker among others. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation New Onset
What is being tested?
Prophylactic amiodarone and posterior pericardiotomy
How many people
242 participants
Where
1 siteUnited States
Study dates
19 Sep 2022to 15 Mar 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population includes all patients undergoing coronary artery bypass cardiac surgery at the Massachusetts General Hospital who meets the above criteria.

Who may be able to join

  • Preoperative normal sinus rhythm
  • Procedures:
  • CABG
  • CABG + concomitant valve or aortic replacement/repair

Who cannot join

  • Emergent operation
  • Procedures:
  • MAZE or PVI performed
  • Isolated valve replacement or repair
  • Isolated aortic procedures
  • Heart transplant
Show all 15Show fewer
  • Lung transplant Pre-existing atrial arrhythmias Pre-operative amiodarone use Contraindications to amiodarone use
  • PR interval > 240 ms
  • 2nd or 3rd degree heart block
  • QTc > 550ms
  • 2nd or 3rd degree heart block
  • Liver impairment (INR > 1.7, AST/ALT > 2x normal)
  • Uncontrolled hypothyroidism/hyperthyroidism
  • Interstitial lung disease
  • Allergy to amiodarone

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery with an estimated incidence around 35%. It has been found to be an independent predictor of 30-day and 6-month mortality, stroke, renal failure, respiratory failure, and need for permanent pacemaker among others. Previous studies including meta-analyses demonstrate a protective benefit of prophylactic amiodarone to decrease the risk of POAF. However, this has not been widely adopted, and recent society guidelines only give prophylactic amiodarone a Class IIA recommendation, citing risk of amiodarone-related toxicity and hypotension as reasons for the Class IIA recommendation. A meta-analysis comparing cumulative doses of amiodarone found that moderate to higher doses of amiodarone have a marginally increased benefit in reducing the incidence of postoperative atrial fibrillation over lower doses; however, the study did not assess risk of complications stratified by cumulative doses, which has been previously described. Finally, a recent meta-analysis showed that a posterior pericardiotomy was highly effective at reducing postoperative atrial fibrillation. Consequently, the investigators' institution has adopted a pharmaco-surgical approach (prophylactic amiodarone and posterior pericardiotomy) in an effort to reduce postoperative atrial fibrillation after coronary artery bypass cardiac surgery for all patients who meet inclusion/exclusion criteria.

Being tested
Prophylactic amiodarone and posterior pericardiotomy
Keywords
Postoperative atrial fibrillation

What participants receive

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

  • Prophylactic amiodarone and posterior pericardiotomyOther

    Patients after the implementation of the protocol receive postoperative prophylactic amiodarone and a posterior pericardiotomy.

    The amiodarone regimen consists of amiodarone 1mg/min x 10 hours (600 mg total) via central line upon arrival to the intensive care unit followed by 400 mg PO BID on postoperative days 1 and 2 followed by 200 mg PO BID on postoperative days 3 and 4 or until discharge, whichever occurs first.

    The posterior pericardiotomy occurs during the cardiac procedure.

Study groups in NCT05780320
Study groupRoleWhat they receive
Pharmaco-Surgical ArmNot described
Receives: Other: Prophylactic amiodarone and posterior pericardiotomy
Standard of Care ArmNot described

What is being measured

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

  1. Postoperative atrial fibrillation

    At least 1 minute duration detected by continuous telemetry or 12-lead electrocardiogram.

    Measured: Prior to patient discharge or within 30 days after surgery.

Secondary outcomes (10)

  1. Operative mortality

    Operative mortality as defined by either in-hospital death or death within 30 days of discharge.

    Measured: Either in-hospital death or death within 30 days of discharge

  2. Stroke

    Characterized by deficits lasting > 24 hours and/or imaging findings of infarction

    Measured: Either in-hospital or within 30 days of procedure

  3. Transient ischemic attack

    Characterized by examination findings lasting < 24 hours without associated imaging findings

    Measured: Either in-hospital or within 30 days of procedure

  4. Initiation of systemic anticoagulation

    New indication of systemic anticoagulation for stroke prophylaxis due to atrial fibrillation

    Measured: Either in-hospital or within 30 days of procedure

  5. Persistence of atrial fibrillation at discharge

    Atrial fibrillation as diagnosed by final ECG

    Measured: At postoperative surgical visit (around 4-6 weeks)

  6. Postoperative hospital length of stay

    The postoperative length of stay will be calculated starting from the end of the procedure to time of discharge

    Measured: Up to 90 days

  7. Readmission

    Rates of hospital readmission will be estimated for patients in each of the study intervention groups. Readmissions will be counted in this calculation if patients are admitted to the hospital. Emergency room visits without admission and outpatient visits will not count toward this calculation of readmission rates.

    Measured: Within 30 days of procedure

  8. Symptomatic bradycardia

    Symptomatic bradycardia (HR < 55 bpm) requiring intervention

    Measured: Either in-hospital or within 30 days of procedure

  9. Number of patients with Amiodarone-related pulmonary toxicity

    Clinical diagnosis of amiodarone-related pulmonary toxicity that uses a combination of x-ray findings consistent with known amiodarone-related pulmonary toxicity and clinical findings including shortness of breath, non-productive cough, and other diagnoses have been excluded.

    Measured: Either in-hospital or within 30 days of procedure

  10. Postoperative pleural effusions requiring intervention

    Postoperative pleural effusions requiring interventions including thoracostomy drainage or surgical drainage

    Measured: Either in-hospital or within 30 days of procedure

Timeline

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

  1. First posted22 Mar 2023
  2. Study start19 Sep 2022
  3. Primary completion15 Nov 2024
  4. Study completion15 Mar 2025

Resources

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
Retrospective
Enrolment
242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05780320
Sponsor's protocol ID
2004P001528
Status last verified
Nov 2025
First submitted
28 Feb 2023
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Greenberg JW, Lancaster TS, Schuessler RB, Melby SJ. Postoperative atrial fibrillation following cardiac surgery: a persistent complication. Eur J Cardiothorac Surg. 2017 Oct 1;52(4):665-672. doi: 10.1093/ejcts/ezx039.

    PubMed 28369234

  • Arsenault KA, Yusuf AM, Crystal E, Healey JS, Morillo CA, Nair GM, Whitlock RP. Interventions for preventing post-operative atrial fibrillation in patients undergoing heart surgery. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD003611. doi: 10.1002/14651858.CD003611.pub3.

    PubMed 23440790

  • Chatterjee S, Sardar P, Mukherjee D, Lichstein E, Aikat S. Timing and route of amiodarone for prevention of postoperative atrial fibrillation after cardiac surgery: a network regression meta-analysis. Pacing Clin Electrophysiol. 2013 Aug;36(8):1017-23. doi: 10.1111/pace.12140. Epub 2013 Apr 29.

    PubMed 23627761

  • Buckley MS, Nolan PE Jr, Slack MK, Tisdale JE, Hilleman DE, Copeland JG. Amiodarone prophylaxis for atrial fibrillation after cardiac surgery: meta-analysis of dose response and timing of initiation. Pharmacotherapy. 2007 Mar;27(3):360-8. doi: 10.1592/phco.27.3.360.

    PubMed 17316148

  • Colunga Biancatelli RM, Congedo V, Calvosa L, Ciacciarelli M, Polidoro A, Iuliano L. Adverse reactions of Amiodarone. J Geriatr Cardiol. 2019 Jul;16(7):552-566. doi: 10.11909/j.issn.1671-5411.2019.07.004.

    PubMed 31447894

  • Orr CF, Ahlskog JE. Frequency, characteristics, and risk factors for amiodarone neurotoxicity. Arch Neurol. 2009 Jul;66(7):865-9. doi: 10.1001/archneurol.2009.96.

    PubMed 19597088

  • Wolkove N, Baltzan M. Amiodarone pulmonary toxicity. Can Respir J. 2009 Mar-Apr;16(2):43-8. doi: 10.1155/2009/282540.

    PubMed 19399307

  • Gaudino M, Sanna T, Ballman KV, Robinson NB, Hameed I, Audisio K, Rahouma M, Di Franco A, Soletti GJ, Lau C, Rong LQ, Massetti M, Gillinov M, Ad N, Voisine P, DiMaio JM, Chikwe J, Fremes SE, Crea F, Puskas JD, Girardi L; PALACS Investigators. Posterior left pericardiotomy for the prevention of atrial fibrillation after cardiac surgery: an adaptive, single-centre, single-blind, randomised, controlled trial. Lancet. 2021 Dec 4;398(10316):2075-2083. doi: 10.1016/S0140-6736(21)02490-9. Epub 2021 Nov 14.

    PubMed 34788640

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation New Onset, run by Massachusetts General Hospital 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 4 inclusion and 15 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 5 Dec 2025. 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 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?

Postoperative atrial fibrillation (time frame: Prior to patient discharge or within 30 days after surgery.). 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 NCT05780320, which also lists 8 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 5 Dec 2025.

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