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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

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.

Condition or disease
New Onset Atrial Fibrillation

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.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Subjects with new onset atrial fibrillation
Subjects with new onset atrial fibrillation who may or may not require electrical cardioversion



Primary Outcome Measures :
  1. Time to AF recurrence [ Time Frame: 3 years ]
    Time to AF recurrence based on clinical or ILR monitoring


Secondary Outcome Measures :
  1. All cause death [ Time Frame: 30 days; 6 months; 1 year; 2 years; 3 years ]
    Composite endpoint of all-cause death

  2. AF related re hospitalizations [ Time Frame: 3 years ]
    any hospitalization related to AFib

  3. Occurrence of CVA [ Time Frame: 3 years ]
    Stroke mRs>1 or TIA

  4. Major and minor bleeding [ Time Frame: 3 years ]
    events of major and minor bleeding



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

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): NCT04038944


Contacts
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Contact: Joseph Levine, MD 516-742-5700 joseph.levine@chsli.org
Contact: Elizabeth S Haag, RN MPA 516 562-6790 elizabeth.haag@chsli.org

Locations
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United States, New York
St Francis Hospital Recruiting
Roslyn, New York, United States, 11576
Contact: Elizabeth Haag, BSN MPA    516-562-6790    elizabeth.haag@chsli.org   
Contact: Joseph Levine, MD    516-562-6646    joseph.levine@chsli.org   
St. Francis Hospital Recruiting
Roslyn, New York, United States, 11576
Contact: Joseph Levine, MD    516-562-6646      
Contact: Elizabeth S Haag, RN MPA    516-562-6790    elizabeth.haag@chsli.org   
Principal Investigator: Joseph Levine, MD         
Sponsors and Collaborators
St. Francis Hospital, New York
Investigators
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Principal Investigator: Joseph Levine, MD Saint Francis Memorial Hospital
Publications:

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Responsible Party: St. Francis Hospital, New York
ClinicalTrials.gov Identifier: NCT04038944    
Other Study ID Numbers: 18-19
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
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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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes