Posterior Wall And Left Atrial Appendage Empiric Electrical Isolation for Non-Paroxysmal Atrial F… (NCT04216667) | Clinical Trial Compass
TerminatedNot Applicable
Posterior Wall And Left Atrial Appendage Empiric Electrical Isolation for Non-Paroxysmal Atrial Fibrillation
Stopped: Insufficient enrollment
United States124 participantsStarted 2020-01-16
Plain-language summary
The purpose of this study is to evaluate the safety and effectiveness of empirical posterior wall isolation (PWI), left atrial appendage electrical isolation (LAAEI) and coronary sinus isolation (CSI) when compared to pulmonary vein isolation (PVI) alone:
* PVI alone,
* PVI + PWI,
* PVI + PWI + LAAEI,
* PVI + PWI + LAAEI + CSI.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. Provision of signed and dated informed consent form
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. Male or female, aged 18 or greater
✓. In good general health as evidenced by medical history and diagnosed with symptomatic persistent AF or long-standing persistent AF.
✓. Persistent AF will be defined as a sustained episode lasting \> 7 days and less than 1 year.
✓. Long-standing persistent AF will be defined as a sustained episode lasting more than 1 year and less than 10 years.
✓. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms, or any combination of the above.
✓. At least one episode of persistent AF must have been documented by ECG, Holter, loop recorder, ziopatch, telemetry, trans telephonic monitoring (TTM), or implantable device within last 10 years of enrollment in this investigation.
Exclusion criteria
✕. Patients with paroxysmal AF.
✕. Reversible causes of AF.
✕. Patients with contraindications to systemic anticoagulation with heparin or coumadin, direct thrombin inhibitor or factor Xa inhibitors.
What they're measuring
1
Freedom from documented AF/AT/AFL episodes and all-cause mortality after initial procedure
Timeframe: 12 months
2
A composite of thromboembolic events, myocardial perforation, pulmonary vein stenosis, atrioesophageal fistula, left and right phrenic nerve paralysis, and other serious adverse events within 12 months post-procedure.