Anticoagulant and Antiarrhythmic Management Based on Continuous Rhythm Monitoring

July 29, 2019 updated by: St. Francis Hospital, New York

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

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.

Study Overview

Status

Recruiting

Conditions

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

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Roslyn, New York, United States, 11576
        • Recruiting
        • St. Francis Hospital
        • Contact:
          • Joseph Levine, MD
          • Phone Number: 516-562-6646
        • Contact:
        • Principal Investigator:
          • Joseph Levine, MD
      • Roslyn, New York, United States, 11576

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to AF recurrence
Time Frame: 3 years
Time to AF recurrence based on clinical or ILR monitoring
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause death
Time Frame: 30 days; 6 months; 1 year; 2 years; 3 years
Composite endpoint of all-cause death
30 days; 6 months; 1 year; 2 years; 3 years
AF related re hospitalizations
Time Frame: 3 years
any hospitalization related to AFib
3 years
Occurrence of CVA
Time Frame: 3 years
Stroke mRs>1 or TIA
3 years
Major and minor bleeding
Time Frame: 3 years
events of major and minor bleeding
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Francis Hospital, New York

Investigators

  • Principal Investigator: Joseph Levine, MD, Saint Francis Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2019

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

July 29, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on New Onset Atrial Fibrillation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe