Anticoagulant and Antiarrhythmic Management Based on Continuous Rhythm Monitoring

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04038944

Enrollment

250

Registered

2019-07-31

Start date

2019-07-17

Completion date

2023-09-30

Last updated

2019-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Time to AF recurrence	3 years	Time to AF recurrence based on clinical or ILR monitoring

Secondary

Measure	Time frame	Description
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
All cause death	30 days; 6 months; 1 year; 2 years; 3 years	Composite endpoint of all-cause death

Countries

United States

Contacts

Primary ContactJoseph Levine, MD

joseph.levine@chsli.org516-742-5700

Backup ContactElizabeth S Haag, RN MPA

elizabeth.haag@chsli.org516 562-6790

Outcome results