Atrial FibrillationPALACSNCT02875405
The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery
A study testing Posterior left pericardiotomy in people with Atrial Fibrillation, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to determine if preforming a posterior left pericardiotomy prevents atrial fibrillation after cardiac surgery. 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?
- Posterior left pericardiotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2017to 24 Aug 2021
- Phase
- Interventional
- 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
- all consecutive patients admitted to the department of cardiothoracic surgery of the NYPH-WCMC will be screened for enrollment.
Who cannot join
- preoperative non-sinus rhythm
- history of previous atrial arrhythmia of any type
- reoperations
- mitral or tricuspid valve disease
- surgery of the descending thoracic or thoracoabdominal aorta
- need for hypothermic circulatory arrest
Show all 10Show fewer
- off pump operation
- urgent/emergent presentation
- disease of the left pleura or previous left thoracotomy
- chest deformity
Trial locations and contacts
1 site in 1 country.
United States1 site
Weil Cornell Medical College Department of Cardiothoracic Surgery
New York, New York, 10065
About this study
The purpose of this study is to determine if preforming a posterior left pericardiotomy prevents atrial fibrillation after cardiac surgery.
Read the detailed description
Post-operative atrial fibrillation (POAF) is a common complication of cardiac surgery which is observed in 30-40% of patients. POAF may cause stroke, systemic embolism or cardiac failure and Its detection mandates for additional treatment with variable combinations of drugs to control cardiac rate or rhythm, anticoagulation, and electrical cardioversion, with their side effects and complications. As a result, POAF prolongs hospital stay and increases the costs of hospitalization. Several strategies aimed at reducing the incidence of POAF have been investigated, including beta-blockers, amiodarone, and statins, with unsatisfactory results. Posterior left pericardiotomy has been associated with a reduction in the incidence of POAF in a few studies. However, these studies are flawed by methodological limitations in terms of sample size, inclusion/exclusion criteria, randomization procedure, and suboptimal electrocardiographic monitoring strategies. Moreover, posterior left pericardiotomy requires additional operative time and is associated with procedure-specific complications. As a result, current evidence on posterior pericardiectomy failed to translate into changes in clinical practice and the incidence of POAF remains high.
- Conditions
- Atrial Fibrillation
- Being tested
- Posterior left pericardiotomy
- Keywords
- postoperative, pericardiotomy, prevention, cardiac surgery, left, posterior
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior left pericardiotomyProcedure or surgery
Patient will receive a posterior left sided pericardiotomy. The incision will be made posterior to the phrenic nerve and run from the inferior left pulmonary vein to the diaphragm.
| Study group | Role | What they receive |
|---|---|---|
| Received pericardiotomy | Experimental | Patient will receive a posterior left pericardiotomy at the time of surgery Receives: Procedure: Posterior left pericardiotomy |
| No Pericardiotomy | No intervention | Patient will not receive posterior left pericardiotomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that experience Postoperative Atrial Fibrillation (POAF)
POAF occurrences are defined as any irregular heart rhythm, without detectable P-wave, that lasts more than 30 seconds.
Measured: During hospitalization, approximately 5 days
Secondary outcomes (2)
Duration of Postoperative Atrial Fibrillation (POAF)
Time spent in atrial fibrillation (seconds), defined as the time from the first evidence of atrial fibrillation to the first evidence of sinus rhythm restoration on cardiac monitoring strips or standard electrocardiograms (EKG)
Measured: During hospitalization, approximately 5 days
Duration of Hospitalization
Time (hours) spent in hospital after surgery completion
Measured: During hospitalization, up to 100 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start20 Sep 2017
- Primary completion10 Aug 2021
- Study completion24 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University of the Sacred Heart
- Responsible party
- Sponsor
- Investigators
- Leonard N Girardi, MD, Principal investigator, Weill Cornell Medical College New York Presbyterian HospitalMario F Gaudino, MD, Study chair, Weill Cornell Medical College New York Presbyterian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875405
- Sponsor's protocol ID
- 1502015867
- Acronym
- PALACS
- Status last verified
- Aug 2021
- First submitted
- 25 Jul 2016
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Biancari F, Mahar MA. Meta-analysis of randomized trials on the efficacy of posterior pericardiotomy in preventing atrial fibrillation after coronary artery bypass surgery. J Thorac Cardiovasc Surg. 2010 May;139(5):1158-61. doi: 10.1016/j.jtcvs.2009.07.012. Epub 2009 Aug 18.
PubMed 19691996Kaleda VI, McCormack DJ, Shipolini AR. Does posterior pericardiotomy reduce the incidence of atrial fibrillation after coronary artery bypass grafting surgery? Interact Cardiovasc Thorac Surg. 2012 Apr;14(4):384-9. doi: 10.1093/icvts/ivr099. Epub 2012 Jan 9.
PubMed 22235005Gaudino M, Harik L, Redfors B, Sandner S, Alexander JH, Di Franco A, Dimagli A, Weinsaft J, Perezgrovas-Olaria R, Soletti GJ, Lau C, Mack C, Girardi L. The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery-Extended Follow-Up study (PALACS-EF): rationale and design. Eur Heart J Open. 2023 Nov 17;3(6):oead118. doi: 10.1093/ehjopen/oead118. eCollection 2023 Nov.
PubMed 38035038Rong LQ, Di Franco A, Rahouma M, Dimagli A, Chan J, Lopes AJ, Kim J, Sanna T, Devereux RB, Delgado V, Weinsaft JW, Crea F, Alexander JH, Gillinov M, DiMaio JM, Pryor KO, Girardi L, Gaudino M. Postoperative pericardial effusion, pericardiotomy, and atrial fibrillation: An explanatory analysis of the PALACS trial. Am Heart J. 2023 Jun;260:113-123. doi: 10.1016/j.ahj.2023.03.001. Epub 2023 Mar 18.
PubMed 36934978Gaudino 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 34788640Abouarab AA, Leonard JR, Ohmes LB, Lau C, Rong LQ, Ivascu NS, Pryor KO, Munjal M, Crea F, Massetti M, Sanna T, Girardi LN, Gaudino M. Posterior Left pericardiotomy for the prevention of postoperative Atrial fibrillation after Cardiac Surgery (PALACS): study protocol for a randomized controlled trial. Trials. 2017 Dec 13;18(1):593. doi: 10.1186/s13063-017-2334-4.
PubMed 29237510
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02875405
- Acronym / sponsor ID
- PALACS / 1502015867
- Conditions
- Atrial Fibrillation
- Keywords
- postoperative, pericardiotomy, prevention, cardiac surgery, left, posterior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Catholic University of the Sacred Heart
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 24 Aug 2021 (actual)
- First posted
- 23 Aug 2016 (estimated)
- 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.
The purpose of this study is to determine if preforming a posterior left pericardiotomy prevents atrial fibrillation after cardiac surgery.
Detailed description
Post-operative atrial fibrillation (POAF) is a common complication of cardiac surgery which is observed in 30-40% of patients. POAF may cause stroke, systemic embolism or cardiac failure and Its detection mandates for additional treatment with variable combinations of drugs to control cardiac rate or rhythm, anticoagulation, and electrical cardioversion, with their side effects and complications. As a result, POAF prolongs hospital stay and increases the costs of hospitalization. Several strategies aimed at reducing the incidence of POAF have been investigated, including beta-blockers, amiodarone, and statins, with unsatisfactory results. Posterior left pericardiotomy has been associated with a reduction in the incidence of POAF in a few studies. However, these studies are flawed by methodological limitations in terms of sample size, inclusion/exclusion criteria, randomization procedure, and suboptimal electrocardiographic monitoring strategies. Moreover, posterior left pericardiotomy requires additional operative time and is associated with procedure-specific complications. As a result, current evidence on posterior pericardiectomy failed to translate into changes in clinical practice and the incidence of POAF remains high.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Received pericardiotomy | Experimental | Procedure: Posterior left pericardiotomyPatient will receive a posterior left pericardiotomy at the time of surgery |
| No Pericardiotomy | No intervention | –Patient will not receive posterior left pericardiotomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all consecutive patients admitted to the department of cardiothoracic surgery of the NYPH-WCMC will be screened for enrollment.
Key exclusion criteria (10 listed)
- preoperative non-sinus rhythm
- history of previous atrial arrhythmia of any type
- reoperations
- mitral or tricuspid valve disease
- surgery of the descending thoracic or thoracoabdominal aorta
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 |
|---|---|---|
| Posterior left pericardiotomyPatient will receive a posterior left sided pericardiotomy. The incision will be made posterior to the phrenic nerve and run from the inferior left pulmonary vein to the diaphragm. | Procedure or surgery | Received pericardiotomy |
Primary outcome
Number of participants that experience Postoperative Atrial Fibrillation (POAF)
Time frame: During hospitalization, approximately 5 days
POAF occurrences are defined as any irregular heart rhythm, without detectable P-wave, that lasts more than 30 seconds.
2 secondary outcomes
Duration of Postoperative Atrial Fibrillation (POAF)
Time frame: During hospitalization, approximately 5 days
Duration of Hospitalization
Time frame: During hospitalization, up to 100 days after surgery
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 27 Aug 2021.
- Results publication: PubMed 19691996Biancari F, Mahar MA. Meta-analysis of randomized trials on the efficacy of posterior pericardiotomy in preventing atrial fibrillation after coronary artery bypass surgery. J Thorac Cardiovasc Surg. 2010 May;139(5):1158-61. doi: 10.1016/j.jtcvs.2009.07.012. Epub 2009 Aug 18.
- Results publication: PubMed 22235005Kaleda VI, McCormack DJ, Shipolini AR. Does posterior pericardiotomy reduce the incidence of atrial fibrillation after coronary artery bypass grafting surgery? Interact Cardiovasc Thorac Surg. 2012 Apr;14(4):384-9. doi: 10.1093/icvts/ivr099. Epub 2012 Jan 9.
- Derived from this study: PubMed 38035038Gaudino M, Harik L, Redfors B, Sandner S, Alexander JH, Di Franco A, Dimagli A, Weinsaft J, Perezgrovas-Olaria R, Soletti GJ, Lau C, Mack C, Girardi L. The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery-Extended Follow-Up study (PALACS-EF): rationale and design. Eur Heart J Open. 2023 Nov 17;3(6):oead118. doi: 10.1093/ehjopen/oead118. eCollection 2023 Nov.
- Derived from this study: PubMed 36934978Rong LQ, Di Franco A, Rahouma M, Dimagli A, Chan J, Lopes AJ, Kim J, Sanna T, Devereux RB, Delgado V, Weinsaft JW, Crea F, Alexander JH, Gillinov M, DiMaio JM, Pryor KO, Girardi L, Gaudino M. Postoperative pericardial effusion, pericardiotomy, and atrial fibrillation: An explanatory analysis of the PALACS trial. Am Heart J. 2023 Jun;260:113-123. doi: 10.1016/j.ahj.2023.03.001. Epub 2023 Mar 18.
- Derived from this study: PubMed 34788640Gaudino 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.
- Derived from this study: PubMed 29237510Abouarab AA, Leonard JR, Ohmes LB, Lau C, Rong LQ, Ivascu NS, Pryor KO, Munjal M, Crea F, Massetti M, Sanna T, Girardi LN, Gaudino M. Posterior Left pericardiotomy for the prevention of postoperative Atrial fibrillation after Cardiac Surgery (PALACS): study protocol for a randomized controlled trial. Trials. 2017 Dec 13;18(1):593. doi: 10.1186/s13063-017-2334-4.
- Weill Cornell Department of Cardiothoracic SurgeryLink provided by the sponsor.
- 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.
Leonard N Girardi, MD principal investigator
Weill Cornell Medical College New York Presbyterian Hospital
Mario F Gaudino, MD study chair
Weill Cornell Medical College New York Presbyterian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior left pericardiotomy in people with Atrial Fibrillation, run by Weill Medical College of Cornell University 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 10 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 27 Aug 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 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?
Number of participants that experience Postoperative Atrial Fibrillation (POAF) (time frame: During hospitalization, approximately 5 days). 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 NCT02875405, which also lists 6 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 27 Aug 2021.