Recruiting

Anticoagulants & Antiarrhythmics

Sponsor:

St. Francis Hospital, New York

Code:

NCT04038944

Conditions

New Onset Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

New Onset Atrial Fibrillation

Study ID

NCT04038944

Start date

Jul 17, 2019

Status verified date

Jul, 2019

Completion date

Sep, 2023

Anticipated

Primary completion date

Jul, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Subjects with new onset atrial fibrillation

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

Primary outcome measure

  • Time to AF recurrence [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Locations

St Francis Hospital

Recruiting

Roslyn, New York, United States, 11576

Contacts

St. Francis Hospital

Recruiting

Roslyn, New York, United States, 11576

Contacts

Joseph Levine, MD

516-562-6646

Principal Investigator:

Joseph Levine, MD

More Information

Sponsor

St. Francis Hospital, New York

Last update posted

Jul 31, 2019

Last verified

Jul, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Francis Hospital, New York on 2019-07-31.