IRB Study Number 23-1293
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
The purpose of this study is to establish the safety and effectiveness of pulsed field ablation (PFA) as a more effective initial ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial treatment with antiarrhythmic drugs (AAD). This study intends to compare the rate of freedom from Atrial Fibrillation (AF) between individuals with persistent AF undergoing a pulsed field ablation OR an anti-arrhythmic drug as an initial treatment for their AF by way of the LUX-Dx insertable cardiac monitor(ICM) to detect recurrence of cardiac arrhythmias. Participants involved in the study will be followed for three years.
Inclusion Criteria
To be considered for participation in the AVANT GUARD study, the following inclusion criteria must be met:
- Subject must be 18 years or older and willing and capable of giving informed consent.
- Have symptomatic persistent Atrial Fibrillation as confirmed by medical history.
- Willing to receive LUX-Dx ICM during the study, or already has a LUX-Dx ICM implanted within 6 months of entering the study.
- Willing and capable of participating in all testing associated with the clinical investigation.
Exclusion Criteria
Some criteria that may exclude an individual from participation in the AVANT GUARD study are as follows:
- Over the 6 months preceding enrollment, more than 7-day history of therapeutic AAD use.
- Prior surgical ablations.
- AF that is secondary to other non-cardiac diseases, such as thyroid disease.
- Pregnant or breastfeeding individuals or individuals who plan to become pregnant over the course of the study.
- Prior cardiac conditions including but not limited to: hypertrophic cardiomyopathy, cardiac amyloidosis, any prosthetic heart valve or repair, rheumatic heart disease, class IV heart failure, or awaiting cardiac transplantation.
- Prior non-cardiac conditions including but not limited to: hemi-diaphragmatic paralysis, severe lung disease, renal insufficiency, severe gastrointestinal issues, active malignancy at enrollment, uncontrolled diabetes mellitus, or a life expectancy of less than one year.
- Events including but not limited to the following within 90 days of entering the study: heart attack, cardiac surgery, stroke, TIA, intracranial bleeding, pericarditis or pericardial effusion.
- Health conditions that, in the investigator’s medical opinion, would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation.
- Has operational ICM other than a LUX-Dx ICM and does not express a willingness to receive a LUX-Dx ICM for the study.
