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New treatment option for Post Operative Atrial Fibrillation
Official title BoxX-NoAF Clinical Trial
ClinicalTrials.gov ID: NCT06989775
What this study is testing
- What it's testing
- Post Operative Atrial Fibrillation (POAF) is the most common complication of cardiac surgery. POAF incidence can exceed 50% depending on the patient baseline characteristics and surgery type.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older. Healthy volunteers may be eligible.
You may be able to join if
- Planned and clinically indicated for cardiac surgical procedure requiring cardiac bypass and opening of the pericardium
- Age ≥ 65 years and CHA2DS2-VASc ≥ 3
You likely can't join if
- Documented history of atrial fibrillation or atrial flutter anytime prior to the cardiac surgery
- Prior procedure involving opening the pericardium or entering the pericardial space
- Patients undergoing off-pump surgery
- Prior LAA occlusion, exclusion, or removal (surgical or percutaneous)
- Presence of a permanent pacemaker
- Infiltrative cardiomyopathies (i.e. amyloidosis)
See the full eligibility criteria
- Planned and clinically indicated for cardiac surgical procedure requiring cardiac bypass and opening of the pericardium
- Age ≥ 65 years and CHA2DS2-VASc ≥ 3
- Documented history of atrial fibrillation or atrial flutter anytime prior to the cardiac surgery
- Prior procedure involving opening the pericardium or entering the pericardial space
- Patients undergoing off-pump surgery
- Prior LAA occlusion, exclusion, or removal (surgical or percutaneous)
- Presence of a permanent pacemaker
- Infiltrative cardiomyopathies (i.e. amyloidosis)
- Planned cardiac surgical procedure using non-sternotomy approaches
- Patients whose planned procedure is a heart transplant or implantation of any long-term ventricular assist devices
- Presence of ventricular arrhythmia
- Active endocarditis
- NYHA Class IV heart failure symptoms
- Preoperative need for an intra-aortic ballon pump or intravenous inotropes
- Active systemic infection at the time of cardiac surgery requiring antibiotics
- Known allergy to Nitinol or nickel sensitivity
- Known medical condition with expected survival of less than 1 year
- Other comorbidities that in the Investigator's opinion make the subject unsuitable candidate to complete the protocol required intervention or visits
- Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial
- Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial.
- Pregnancy
- Known severe symptomatic carotid disease
The study team makes the final eligibility decision.
Where it's taking place
- Jonesboro, Arkansas, United States
- San Diego, California, United States
- Clearwater, Florida, United States
- Orlando, Florida, United States
- Sarasota, Florida, United States
- Atlanta, Georgia, United States
- Marietta, Georgia, United States
- Chicago, Illinois, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Grand Rapids, Michigan, United States
- Ypsilanti, Michigan, United States
- Rochester, Minnesota, United States
- Manhasset, New York, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jonesboro, Arkansas, United States; San Diego, California, United States; Clearwater, Florida, United States; Orlando, Florida, United States; Sarasota, Florida, United States; Atlanta, Georgia, United States and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.