Clinical trial NCT04038944: Anticoagulant and Antiarrhythmic Management Based on Continuous Rhythm Monitoring
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: New Onset Atrial Fibrillation
Lead sponsor: St. Francis Hospital, New York
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Time to AF recurrence
timeFrame: 3 years
Secondary outcomes:
measure: All cause death
timeFrame: 30 days; 6 months; 1 year; 2 years; 3 years
measure: AF related re hospitalizations
timeFrame: 3 years
measure: Occurrence of CVA
timeFrame: 3 years
measure: Major and minor bleeding
timeFrame: 3 years
Other outcomes:
Locations:
city: Roslyn
country: United States
facility: St Francis Hospital
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
Study officials:
affiliation: Saint Francis Hospital
name: Joseph Levine, MD
role: PRINCIPAL_INVESTIGATOR
References:
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