Posterior Wall And Left Atrial Appendage Empiric Electrical Isolation for Non-Paroxysmal Atrial Fibrillation

Stopped early · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT04216667

Run by

Montefiore Medical Center

People needed

124

Starts

2020-01-16

Expected to finish

2023-06-30

Last updated by the study team

2023-08-31

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Patients undergoing first time procedure for AF.

You may not qualify if…

• Patients with paroxysmal AF.
• Paroxysmal AF will be defined as a sustained episode lasting < 7 days (either terminated spontaneously or with pharmacological or electrical cardioversion.
• Reversible causes of AF.
• Patients with contraindications to systemic anticoagulation with heparin or coumadin, direct thrombin inhibitor or factor Xa inhibitors.
• Patients with left atrial size ≥ 75 mm (2D echocardiography, parasternal long axis view)
• Left atrial or LAA thrombus
• Patients with severe valvular heart disease or after mitral valve replacement (bioprosthetic or mechanical).
• Patients with a life expectancy ≤ 24 months
• CHA2DS2Vasc score of 0 for men and CHA2DS2Vasc score of 1 for women.
• Patients who are pregnant.

Where it is running

• Grandview Medical Center — Birmingham, Alabama, United States
• MarinHealth Medical Center — Larkspur, California, United States
• University of Colorado — Boulder, Colorado, United States
• Miami Cardiac & Vascular Institute — Miami, Florida, United States
• Indiana University — Bloomington, Indiana, United States
• Montefiore Medical Center — The Bronx, New York, United States
• WakedMed Heart & Vascular — Raleigh, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Texas Cardiac Arrhythmia Institute — Austin, Texas, United States
• Baylor Heart Clinic — Houston, Texas, United States
• Instituto Cardiovascular Adventista — Buenos Aires, Argentina
• Incor - HCFMUSP — São Paulo, Brazil
• University CES — Medellín, Antioquia, Colombia
• Cardioangiologisches Centrum Bethanien — Frankfurt, Germany
• Hospital Santa Cruz — Lisbon, Portugal
• Hacettepe University — Ankara, Turkey (Türkiye)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.