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Trial record 19 of 172 for:    "Heart Disease" | "Heparin"

Heparin Requirements in Patients Undergoing Atrial Fibrillation Ablation on Coumadin vs NOACs

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ClinicalTrials.gov Identifier: NCT03520868
Recruitment Status : Recruiting
First Posted : May 10, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Orlov, Steward St. Elizabeth's Medical Center of Boston, Inc.

Brief Summary:
To observe, using a prospectively designed study, the effect of type of oral anticoagulant on intra-procedural heparin requirements in patients undergoing Atrial Fibrillation ablation and to assess whether ACT assay accurately reflects heparin anti coagulation effect.

Condition or disease Intervention/treatment
Atrial Fibrillation Diagnostic Test: Monitoring Anti Factor Xa level

Detailed Description:
Atrial fibrillation (AF) is the most common arrhythmia affecting the US population and accounts for 15% of strokes worldwide. Radiofrequency ablation has become a frequently used therapy for treatment of afib after failure of at least one anti-arrhythmic drug. Pulmonary Vein Isolation (PVI) remains the cornerstone of AF ablation and requires transseptal puncture and placement of catheters in the left atrium which can be thrombogenic and cause stroke. This is avoided by intra-procedural infusion of heparin and the anti-coagulation effect is monitored using Activated Clotting Time (ACT). With the approval of Novel Oral Anti-Coagulants (NOAC), increasing number of patients are undergoing AF ablation on these medications. It has been observed that patients on NOACs require much larger doses of heparin and take longer time to reach therapeutic ACT. Consequently, patients are at higher risk for thromboembolism and stroke. On the other hand, higher doses of heparin can expose patients to excessive bleeding complications. The investigators seek to explain the mechanism of "heparin resistance" in such a patient population and to develop a protocol that can achieve therapeutic anticoagulation quicker.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Heparin Requirements in Patients Undergoing Atrial Fibrillation Ablation on Coumadin vs NOACs
Actual Study Start Date : May 5, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : August 4, 2019


Group/Cohort Intervention/treatment
Coumadin
Coumadin patients with undergo standard procedure with monitoring of Anti-Factor Xa assay level before and during the procedure. Heparin bolus given will be based on 70 U/kg
Diagnostic Test: Monitoring Anti Factor Xa level
Each patient will have baseline Anti-Factor Xa assay checked. During the procedure, Anti-Factor Xa assay is checked concurrently with ACT after heparin bolus and infusion.

Dabigatran
Dabigatran patients with undergo standard procedure with monitoring of Anti-Factor Xa assay level before and during the procedure. Heparin bolus given will be based on 110 U/kg
Diagnostic Test: Monitoring Anti Factor Xa level
Each patient will have baseline Anti-Factor Xa assay checked. During the procedure, Anti-Factor Xa assay is checked concurrently with ACT after heparin bolus and infusion.

Rivaroxiban
Rivaroxiban patients with undergo standard procedure with monitoring of Anti-Factor Xa assay level before and during the procedure. Heparin bolus given will be based on 110 U/kg
Diagnostic Test: Monitoring Anti Factor Xa level
Each patient will have baseline Anti-Factor Xa assay checked. During the procedure, Anti-Factor Xa assay is checked concurrently with ACT after heparin bolus and infusion.

Apixaban
Apixaban patients with undergo standard procedure with monitoring of Anti-Factor Xa assay level before and during the procedure. Heparin bolus given will be based on 10 U/kg
Diagnostic Test: Monitoring Anti Factor Xa level
Each patient will have baseline Anti-Factor Xa assay checked. During the procedure, Anti-Factor Xa assay is checked concurrently with ACT after heparin bolus and infusion.




Primary Outcome Measures :
  1. Intra-procedural Heparin Requirements in patients taking NOACs and Coumadin [ Time Frame: During the procedure ]
    The investigators will measure the amount of intravenous heparin administered to each patient during the afib ablation to achieve therapeutic anticoagulation.


Secondary Outcome Measures :
  1. Anti Factor Xa assay measured to assess Heparin activity during Atrial Fibrillation Ablation [ Time Frame: During the procedure ]
    The intra-procedural heparin activity is measured using Anti Factor Xa assay.

  2. Activated Clotting Time (ACT) measured to assess Heparin activity during Atrial Fibrillation Ablation [ Time Frame: During the procedure ]
    The intra-procedural heparin activity is measured using ACT


Biospecimen Retention:   Samples With DNA
Serum blood test


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All adults, male and female, aged 18 and above, who have been referred to the EP lab for elective PVI (Pulmonary Vein Isolation).
Criteria

Inclusion Criteria:

  • All adults, male and female, aged 18 and above.
  • Patients with paroxysmal, persistent or chronic AF
  • All patients must be on therapeutic doses of Coumadin or one of the NOACs for at least 1 month prior to the procedure.

Exclusion Criteria:

  • Patients with known primary or secondary coagulopathy (such as Hemophilia, vWF deficiency, active malignancy, ATIII deficiency, Factor V Leiden deficiency, Hx of recurrent DVT/PE)
  • Patients with hypoalbuminemia, cirrhosis
  • chronic LMWH therapy,
  • ESRD on HD, and severely impaired kidney function with CKD stage IV
  • BMI >35
  • prosthetic heart valves and
  • advanced liver disease
  • previous procedural complications such as tamponade

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520868


Contacts
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Contact: Michael V Orlov, MD 617-789-3000 ext 3187 michael.orlov@steward.org
Contact: Wajih A Syed, MD 617-789-3000 ext 3109 wajihakbarsyed@yahoo.com

Locations
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United States, Massachusetts
St Elizabeth Medical Center Recruiting
Brighton, Massachusetts, United States, 02135
Contact: Michael V Orlov, MD    617-789-3000 ext 3187    michael.orlov@steward.org   
Contact: Wajih Syed, md    617-789-3000 ext 3109    wajih.syed@steward.org   
Sponsors and Collaborators
Steward St. Elizabeth's Medical Center of Boston, Inc.
Investigators
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Principal Investigator: Michael V Orlov, MD Steward St. Elizabeth's Medical Center of Boston, Inc.

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Responsible Party: Michael Orlov, Electrophysiologist, Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier: NCT03520868     History of Changes
Other Study ID Numbers: 00747
First Posted: May 10, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Heparin
Calcium heparin
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes
Warfarin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action