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Anticoagulant and Antiarrhythmic Management Based on Continuous Rhythm Monitoring

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038944
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
St. Francis Hospital, New York

Tracking Information
First Submitted Date July 29, 2019
First Posted Date July 31, 2019
Last Update Posted Date July 31, 2019
Actual Study Start Date July 17, 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 29, 2019)
Time to AF recurrence [ Time Frame: 3 years ]
Time to AF recurrence based on clinical or ILR monitoring
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 29, 2019)
  • All cause death [ Time Frame: 30 days; 6 months; 1 year; 2 years; 3 years ]
    Composite endpoint of all-cause death
  • AF related re hospitalizations [ Time Frame: 3 years ]
    any hospitalization related to AFib
  • Occurrence of CVA [ Time Frame: 3 years ]
    Stroke mRs>1 or TIA
  • Major and minor bleeding [ Time Frame: 3 years ]
    events of major and minor bleeding
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 Anticoagulant and Antiarrhythmic Management Based on Continuous Rhythm Monitoring
Official Title Anticoagulant and Antiarrhythmic Management Based on Continuous Rhythm Monitoring and Cardiac Imaging in Patients at Low Risk for Cardiovascular Events Following Direct Current Cardioversion for New Onset Atrial Fibrillation
Brief Summary This pilot study aims to assess the feasibility and safety of using an ILR to identify the incidence of recurrent AF after an episode of newly diagnosed AF. The study further aims to assess the risk of AF recurrence in this low risk population based on left atrial and left atrial appendage anatomic and functional indices in addition to the standardized clinical CHA2DS2-Vasc score.
Detailed Description

There is a significant incidence of recurrent AF following initial diagnosis of AF.

Inclusion of left atrial (LA) and left atrial appendage (LAA) abnormalities together with risk prediction of CVA using CHA2DS2-Vasc score will identify patients at low or high risk for adverse cardiovascular events in patients with manifest and silent AF.

Patients requiring cardioversion have higher risk of recurrent AF in follow up.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The trial will include 250 subjects who have been identified with initial diagnosis of AF and for whom a rhythm control strategy has been chosen with the primary endpoint being time to AF recurrence, AF burden, and AF management at 1 and 3 years.
Condition New Onset Atrial Fibrillation
Intervention Not Provided
Study Groups/Cohorts Subjects with new onset atrial fibrillation
Subjects with new onset atrial fibrillation who may or may not require electrical cardioversion
Publications *

*   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: July 29, 2019)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2023
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Newly diagnosed AF
  3. Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule

Exclusion Criteria:

  1. Patient is participating in or plans to participate in any other investigational drug or device clinical trial that has not reached its primary endpoint
  2. Patient received an organ transplant, or is on a waiting list.
  3. Patient is not able to follow instructions for remote monitoring 4 Prior history of AF
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Joseph Levine, MD 516-742-5700 joseph.levine@chsli.org
Contact: Elizabeth S Haag, RN MPA 516 562-6790 elizabeth.haag@chsli.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04038944
Other Study ID Numbers 18-19
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 St. Francis Hospital, New York
Study Sponsor St. Francis Hospital, New York
Collaborators Not Provided
Investigators
Principal Investigator: Joseph Levine, MD Saint Francis Memorial Hospital
PRS Account St. Francis Hospital, New York
Verification Date July 2019