Anticoagulant and Antiarrhythmic Management Based on Continuous Rhythm Monitoring

• Conditions: New Onset Atrial Fibrillation

• Registration Number: NCT04038944
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2019-07
• Study Start: 2019-07-17
• Study First Submitted: 2019-07-29
• Study First Submitted QC: 2019-07-29
• Last Update Submitted: 2019-07-29
• Study First Posted: 2019-07-31
• Last Update Posted: 2019-07-31
• Primary Completion: 2020-07
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to AF recurrence	3 years	Time to AF recurrence based on clinical or ILR monitoring

Secondary Outcome Measures

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

Trial Locations

Locations (2)

St Francis Hospital; 🇺🇸 Roslyn, New York, United States

St. Francis Hospital; 🇺🇸 Roslyn, New York, United States