Assessment of Cardioversion Using Transesophageal Echocardiography II (ACUTE II)

NCT00289042 | Completed Phase 4

• 1 other identifier: IRB 2879
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

SPECIFIC AIM: To test the safety and feasibility of using low molecular weight heparin (LMWH, enoxaparin sodium; Lovenox, Sanofi-Aventis) in lieu of unfractionated heparin (UFH) as antithrombotic therapy for patients in atrial fibrillation undergoing transesophageal echocardiography (TEE) guided chemical or electrical cardioversion to sinus rhythm. HYPOTHESIS: Early cardioversion from atrial fibrillation can be safely performed using a short-term anticoagulation strategy of low molecular weight heparin (Lovenox, Sanofi-Aventis) compared to unfractionated heparin, accompanied by a TEE examination prior to cardioversion. The use of LMWH with TEE will result in a safe, cost-effective, and possible efficacious approach to cardioversion of atrial fibrillation compared to UFH with TEE.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; atrial thrombus; cardioversion; enoxaparin; low molecular weight heparin; transesophageal echocardiography

Outcome Measures

Primary Outcomes (7)

• ischemic stroke

• transient ischemic attack

• peripheral embolism

• major or minor bleeding

• death

• length of stay (LOS)

• return to normal sinus rhythm (NSR)

Secondary Outcomes (2)

• quality of life

• cost-effectiveness

Interventions

Enoxaparin DRUG

Eligibility Criteria

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

You may qualify if:

• Patients with chronic or paroxysmal atrial fibrillation of \> 2 days duration who are candidates for early chemical or electrical cardioversion
• Patients with atrial flutter with a documented history (electrocardiography) of atrial fibrillation
• Males and females 18 years of age or older
• Patients have available results of routine clinical labs for standard clinical chemistry and complete blood count within the previous 14 days

You may not qualify if:

• An INR \> 1.4 in patients who have received warfarin prior to enrollment.
• Use of IV heparin for more than 72 hours immediately prior to randomization.
• Patients with contraindications to TEE, such as dysphagia, or esophageal strictures.
• Patients who will need anticoagulation discontinued because of elective intervening procedure, such as cardiac catheterization or surgery.
• Patients with contraindications to warfarin or heparin
• Patients who require concomitant therapy during the study period with any drug known to affect coagulation or platelet function (i.e. ASA, NSAID, antiplatelet drugs)
• Women of childbearing potential, unless pregnancy can be excluded by medical history incompatible with pregnancy or by serum or urine beta HCG levels.
• Patients who are hemodynamically unstable and thus may require immediate cardioversion.
• Weight less than 40 kg (88 pounds) or more than 125 kg (275 pounds)
• History of gastrointestinal bleeding disorder and/or endoscopically verified ulcer disease within the last year
• History of intracranial or retinal bleeding, or other known disorders with an increased risk of bleeding
• Ischemic stroke in the previous three months
• Uncontrolled hypertension (systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 100 mm Hg)
• Malignancy currently under active treatment, including melanoma
• Patients with renal insufficiency (creatinine \> 2.0 mg/dL) or are renal transplant subjects

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Sanofi: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (4)

• Klein AL, Grimm RA, Murray RD, Apperson-Hansen C, Asinger RW, Black IW, Davidoff R, Erbel R, Halperin JL, Orsinelli DA, Porter TR, Stoddard MF; Assessment of Cardioversion Using Transesophageal Echocardiography Investigators. Use of transesophageal echocardiography to guide cardioversion in patients with atrial fibrillation. N Engl J Med. 2001 May 10;344(19):1411-20. doi: 10.1056/NEJM200105103441901.

  PMID: 11346805 BACKGROUND

• Murray RD, Deitcher SR, Shah A, Jasper SE, Bashir M, Grimm RA, Klein AL. Potential clinical efficacy and cost benefit of a transesophageal echocardiography-guided low-molecular-weight heparin (enoxaparin) approach to antithrombotic therapy in patients undergoing immediate cardioversion from atrial fibrillation. J Am Soc Echocardiogr. 2001 Mar;14(3):200-8. doi: 10.1067/mje.2001.109505.

  PMID: 11241016 BACKGROUND

• Murray RD, Shah A, Jasper SE, Goodman A, Deitcher SR, Katz WE, Malouf JF, Stoddard MF, Grimm RA, Klein AL; ACUTE II pilot study. Transesophageal echocardiography guided enoxaparin antithrombotic strategy for cardioversion of atrial fibrillation: the ACUTE II pilot study. Am Heart J. 2000 Jun;139(6):E1-7. doi: 10.1067/mhj.2000.106628.

  PMID: 10827367 BACKGROUND

• Elliott DJ, Zhao L, Jasper SE, Lieber EA, Klein AL, Weintraub WS. Health status outcomes after cardioversion for atrial fibrillation: results from the Assessment of Cardioversion Using Transesophageal Echocardiography (ACUTE) II Trial. Am Heart J. 2008 Aug;156(2):374.e1-6. doi: 10.1016/j.ahj.2008.05.008.

  PMID: 18657673 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Allan L. Klein, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 8, 2006
• First Posted: February 9, 2006
• Study Start: December 1, 1999
• Study Completion: November 1, 2004
• Last Updated: January 31, 2007

Record last verified: 2005-05

Locations

US (1)