Subclinical Postoperative Atrial Fibrillation

NCT02522364 | Unknown DMC

• 1 other identifier: SHEBA-05-2282-MG-CTIL
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative atrial fibrillation and atrial flutter (POAF) is the most common complication after cardiac surgery requiring intervention or prolonged hospital stay. POAF is associated with higher mortality and higher risk of thromboembolic events. However, It is yet unknown whether a now event of postoperative atrial fibrillation is an indication of a chronic arrhythmic disease - a tendency towards developing recurrent atrial fibrillation or merely a response to the stress of surgery with not recurrence. This distinction is critical to determine the appropriate therapy. Since recurred events of atrial fibrillation (Paroxysmal atrial fibrillation) are associated with long term risk for stroke and thromboembolic evens patients with PAF are treated with long term anticoagulation. Missing the long term recurrence of arrhythmia may result in under-treatment and pose a significant risk of stroke. Bio-Monitor is a subcutaneous implanted device that automatically detects arrhythmias and stores electrocardiogram (ECG) recordings. It will enable the detection of atrial fibrillation over a period of years and allow correct diagnosis and appropriate treatment. The purpose of the study is to study the long term behavior of POAF, determine the likelihood of developing paroxysmal atrial fibrillation in patients with POAF and to define the risk factors for this eventuality

Conditions

Atrial Fibrillation

Keywords

Postoperative atrial fibrillation; Dysfunction Following Cardiac Surgery

Outcome Measures

Primary Outcomes (8)

• Atrial fibrillation event

  Documented Atrial fibrillation of more the 5 minutes duration

  2 years

• MACCE

  A composite of all -cause mortality, CT/MRI proven stroke, CT proven systemic embolism

  2 years

• Implantation of permanent pacemaker

  2 years

• Implantation of ICD

  Implantation of ICD following documented ventricular arrhythmia

  2 years

• Pocket hematoma

  The development of a hematoma in the BioMonitor insertion site

  30 days

• Pocket site infection

  The development of a Pocket site infection in the BioMonitor insertion site

  2 years

• Device extraction

  2 years

• Major bleeding

  A composite of the following events: i. Bleeding resulting in a decrease in hemoglobin of ≥2 g/dL or over a 24-hour period ii. Bleeding leading to a transfusion of 2 or more units of packed red blood cells iii. Bleeding that occurs in a critical site (intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome or retroperitoneal) iv. Bleeding that leads to death.

  2 years

Secondary Outcomes (5)

• All -cause mortality

  2 years

• CT/MRI proven stroke

  2 years

• Rapid AF requiring hospitalization

  2 years

• Initiation of long term anti-coagulation therapy

  2 years

• Initiation of long term anti-arrhythmic therapy

  2 years

Study Arms (2)

BioMonitor

ACTIVE COMPARATOR

Participants randomized for this arm will be implanted with a BioMonitor device an implantable loop recorder inserted under the skin in the region of the thorax. It continuously records heart rhythm for a period of up to 7 years. The device will be interrogated at 1 month intervals. All arrhythmic events and conductive disturbances will be noted. In addition will be followed as specified in the standard arm

Device: BioMonitor device

Standard

ACTIVE COMPARATOR

Participants randomized for this arm will be followed by biannual office visits initialing clinical evaluation, review of clinical events, review and update of medical therapy. Participants will undergo ECG holter examination at 3 and 6 months after discharge

Other: Standard

Interventions

BioMonitor device DEVICE

Implantation of a BioMonitor device and continuously monitoring heart rhythm for study duration

BioMonitor

Standard OTHER

Clinical and intermittent electrocardiographic follow-up of patients

Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly documented POAF of more than 5 minute duration
• cardiac surgery during index hospitalization, including (CABG, valvular replacement or repair, a combination) without Maze procedure
• CHA2DS2-VASc≥2
• Sinus rhythm at the time of BioMonitor implantation or definite intention to cardiovert prior to discharge
• Signed Informed Consent

You may not qualify if:

• History of atrial fibrillation/flutter prior to cardiac surgery
• Contraindication for anticoagulation therapy
• Dual chamber pacemaker or ICD implanted or planned
• Active systemic infection
• Another (non-AF) indication for long term anticoagulation
• Maze procedure
• Inability to attend scheduled, periodic office visits for follow-up
• Pregnancy

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

RECRUITING

Related Publications (13)

• Aranki SF, Shaw DP, Adams DH, Rizzo RJ, Couper GS, VanderVliet M, Collins JJ Jr, Cohn LH, Burstin HR. Predictors of atrial fibrillation after coronary artery surgery. Current trends and impact on hospital resources. Circulation. 1996 Aug 1;94(3):390-7. doi: 10.1161/01.cir.94.3.390.

  PMID: 8759081 RESULT

• Mitchell LB; CCS Atrial Fibrillation Guidelines Committee. Canadian Cardiovascular Society atrial fibrillation guidelines 2010: prevention and treatment of atrial fibrillation following cardiac surgery. Can J Cardiol. 2011 Jan-Feb;27(1):91-7. doi: 10.1016/j.cjca.2010.11.005.

  PMID: 21329866 RESULT

• Maisel WH, Rawn JD, Stevenson WG. Atrial fibrillation after cardiac surgery. Ann Intern Med. 2001 Dec 18;135(12):1061-73. doi: 10.7326/0003-4819-135-12-200112180-00010.

  PMID: 11747385 RESULT

• Creswell LL, Schuessler RB, Rosenbloom M, Cox JL. Hazards of postoperative atrial arrhythmias. Ann Thorac Surg. 1993 Sep;56(3):539-49. doi: 10.1016/0003-4975(93)90894-n.

  PMID: 8379728 RESULT

• European Heart Rhythm Association; European Association for Cardio-Thoracic Surgery; Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010 Oct;31(19):2369-429. doi: 10.1093/eurheartj/ehq278. Epub 2010 Aug 29. No abstract available.

  PMID: 20802247 RESULT

• January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; ACC/AHA Task Force Members. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014 Dec 2;130(23):2071-104. doi: 10.1161/CIR.0000000000000040. Epub 2014 Mar 28. No abstract available.

  PMID: 24682348 RESULT

• Kowey PR, Stebbins D, Igidbashian L, Goldman SM, Sutter FP, Rials SJ, Marinchak RA. Clinical outcome of patients who develop PAF after CABG surgery. Pacing Clin Electrophysiol. 2001 Feb;24(2):191-3. doi: 10.1046/j.1460-9592.2001.00191.x.

  PMID: 11270698 RESULT

• Lee JK, Klein GJ, Krahn AD, Yee R, Zarnke K, Simpson C, Skanes A, Spindler B. Rate-control versus conversion strategy in postoperative atrial fibrillation: a prospective, randomized pilot study. Am Heart J. 2000 Dec;140(6):871-7. doi: 10.1067/mhj.2000.111104.

  PMID: 11099990 RESULT

• Pillarisetti J, Patel A, Bommana S, Guda R, Falbe J, Zorn GT, Muehlebach G, Vacek J, Sue Min Lai, Lakkireddy D. Atrial fibrillation following open heart surgery: long-term incidence and prognosis. J Interv Card Electrophysiol. 2014 Jan;39(1):69-75. doi: 10.1007/s10840-013-9830-6. Epub 2013 Nov 29.

  PMID: 24293173 RESULT

• Ahlsson A, Fengsrud E, Bodin L, Englund A. Postoperative atrial fibrillation in patients undergoing aortocoronary bypass surgery carries an eightfold risk of future atrial fibrillation and a doubled cardiovascular mortality. Eur J Cardiothorac Surg. 2010 Jun;37(6):1353-9. doi: 10.1016/j.ejcts.2009.12.033.

  PMID: 20138531 RESULT

• Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.

  PMID: 25173339 RESULT

• Lee SH, Kang DR, Uhm JS, Shim J, Sung JH, Kim JY, Pak HN, Lee MH, Joung B. New-onset atrial fibrillation predicts long-term newly developed atrial fibrillation after coronary artery bypass graft. Am Heart J. 2014 Apr;167(4):593-600.e1. doi: 10.1016/j.ahj.2013.12.010. Epub 2014 Jan 4.

  PMID: 24655710 RESULT

• Lubitz SA, Yin X, Rienstra M, Schnabel RB, Walkey AJ, Magnani JW, Rahman F, McManus DD, Tadros TM, Levy D, Vasan RS, Larson MG, Ellinor PT, Benjamin EJ. Long-term outcomes of secondary atrial fibrillation in the community: the Framingham Heart Study. Circulation. 2015 May 12;131(19):1648-55. doi: 10.1161/CIRCULATIONAHA.114.014058. Epub 2015 Mar 13.

  PMID: 25769640 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Glikson, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Glikson, MD

CONTACT

972-3-5305330; Michael.Glikson@sheba.health.gov.il

Avi Sabbag, MD

CONTACT

+972547897747; avisabbag@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Davidai Arrhythmia Center, Leviev Heart Center, Sheba Medical Center

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: August 13, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2019
• Last Updated: October 19, 2017

Record last verified: 2017-10

Locations

IL (1)