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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.

Tracking Information
First Submitted Date October 31, 2017
First Posted Date May 10, 2018
Last Update Posted Date September 11, 2018
Actual Study Start Date May 5, 2017
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 26, 2018)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03520868 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 26, 2018)
  • 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.
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Heparin Requirements in Patients Undergoing Atrial Fibrillation Ablation on Coumadin vs NOACs
Official Title Heparin Requirements in Patients Undergoing Atrial Fibrillation Ablation on Coumadin vs NOACs
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.
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum blood test
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).
Condition Atrial Fibrillation
Intervention 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.
Study Groups/Cohorts
  • 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
    Intervention: Diagnostic Test: Monitoring Anti Factor Xa level
  • 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
    Intervention: Diagnostic Test: Monitoring Anti Factor Xa level
  • 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
    Intervention: Diagnostic Test: Monitoring Anti Factor Xa level
  • 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
    Intervention: Diagnostic Test: Monitoring Anti Factor Xa level
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 26, 2018)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 4, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
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
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03520868
Other Study ID Numbers 00747
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Michael Orlov, Steward St. Elizabeth's Medical Center of Boston, Inc.
Study Sponsor Steward St. Elizabeth's Medical Center of Boston, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Michael V Orlov, MD Steward St. Elizabeth's Medical Center of Boston, Inc.
PRS Account Steward St. Elizabeth's Medical Center of Boston, Inc.
Verification Date September 2018