Anticoagulant and Antiarrhythmic Management Based on Continuous Rhythm Monitoring

St. Francis Hospital, New York

Status: Unknown

Conditions: New Onset Atrial Fibrillation

Study type: Observational

Funder types: Other

Identifiers

NCT04038944

18-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 1 patient group

Subjects with new onset atrial fibrillation

Description:

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