Please select the eligibility criteria that correspond to the clinical trial below.
Title: Exclusion of the Left Atrial Appendage With the AtriClip LAA Exclusion Device in Patients Undergoing Concomitant Cardiac Surgery
Brief Summary: Prospective, non-randomized trial to evaluate the safety and efficacy of the LAA Exclusion Device (Clip) for the exclusion of the LAA via epicardial tissue approximation.


Options:
A: Inclusion Criteria:

1. Subject is greater than or equal to 18 years of age.
2. Subject has any one of the following risk factors and is thought to benefit from LAA occlusion:

   * CHADS score \> 2
   * Age \> 75 years
   * Hypertension and age \> 65 years
   * Previous stroke
   * History of atrial fibrillation (any classification)
3. Subject is scheduled to undergo elective non-endoscopic cardiac surgical procedure(s) including cardiac surgery for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or placement, Tricuspid valve repair or replacement, Coronary artery bypass procedures, concomitant surgical (ablation or cut-and-sew) Maze procedure, patent foramen ovale (PFO), atrial septal defect (ASD) repair with the device deployed while on or prepared for cardio-pulmonary bypass support.
4. Subject is willing and able to provide written informed consent.
5. Subject has a life expectancy of at least 1 year.
6. Subject is willing and able to return for scheduled follow-up visits.

Exclusion Criteria:

1. Previous cardiac surgery
2. Thrombus in the LAA/LA which cannot be evacuated prior to placement of the Clip.
3. Patients requiring surgery other than CABG and/or cardiac valve and/or surgical maze procedure and/or PFO closure and/or ASD repair.
4. NYHA Class IV heart failure symptoms
5. Need for emergent cardiac surgery (i.e. cardiogenic shock)
6. Creatinine \>200 µmol/L
7. LAA is not appropriate for exclusion based on intraoperative evaluations
8. Current diagnosis of active systemic infection
9. Renal failure requiring dialysis or hepatic failure
10. A known drug and/or alcohol addiction
11. Mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study
12. Pregnancy or desire to get pregnant within 12-months of the study treatment
13. Preoperative need for an intra-aortic balloon pump or intravenous inotropes
14. Patients who have been treated with thoracic radiation
15. Patients in current chemotherapy
16. Patients on long term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases.
17. Patients with known connective tissue disorders
B: Inclusion Criteria:

* Able to sign Informed Consent and Release of Medical Information forms
* Age ≥ 18 years
* Clinical indications for mitral valve surgery for the following:

  1. Organic mitral valve disease; or
  2. Functional non-ischemic mitral regurgitation; or
  3. Ischemic mitral regurgitation with evidence of concomitant structural mitral valve disease

Note: May include need for surgical management of functional tricuspid regurgitation or patent foramen ovale. May also include concomitant CABG, aortic arch or aortic valve procedure. Surgical intervention may be performed via sternotomy or minimally invasive procedure.

* a) Persistent AF within 6 months prior to randomization, defined as non self-terminating AF lasting greater than 7 days but no more than one year, or lasting less than 7 days but necessitating pharmacologic or electrical cardioversion.

  * Duration of AF must be documented by medical history and
  * Presence of AF must be documented by a direct electrocardiographic assessment within 6 months prior to randomization.
* b) Longstanding persistent AF is defined as continuous AF of greater than one year duration.

  * Duration of AF must be documented by medical history and
  * Presence of AF must be documented by a direct electrocardiographic assessment upon arrival in the OR.
* Able to use heart rhythm monitor

Exclusion Criteria:

* 1. AF without indication for mitral valve surgery 2. AF is paroxysmal 3. Evidence of left atrial thrombus by intra-operative TEE 4. Evidence of active infection 5. Mental impairment or other conditions that may not allow subject to understand the nature, significance, and scope of study 6. Surgical management of hypertrophic obstructive cardiomyopathy 7. Previous catheter ablation for AF 8. Life expectancy of less than one year 9. Absolute contraindications for anticoagulation therapy 10. Enrollment in concomitant drug or device trials 11. Uncontrolled hypo- or hyperthyroidism 12. FEV1 \< 30% of predicted value and/or need for home oxygen therapy 13. Women who are pregnant as evidenced by positive pregnancy test 14. Women of childbearing age who do not agree to be on adequate birth control throughout the period of the trial.
C: Inclusion Criteria:

* Patients undergo valvular surgery and/ or coronary surgery,
* All patients have documented chronic atrial fibrillation of paroxysmal atrial fibrillation.
* Patients have given written informed consent.

Exclusion Criteria:

* Patients who do not speak Dutch or can not read Dutch.
* Patients with a Sick Sinus Syndrome.
* Patients with contraindications for oral anticoagulant agents.
* Incompetent to act for oneself
D: Inclusion Criteria:

1. Documented history (paroxysmal, persistent or permanent) of AF \[one episode within the last 12 months of enrollment\]
2. Elective Maze procedure
3. Suitable anatomy
4. Able and willing to sign informed consent
5. Age over 18 years

Exclusion Criteria:

1. Patient from Intensive Care Unit with either:

   1. intra-venous catecholamines
   2. ventilator
   3. cardiac index \<1.8 l/min.
2. Reoperative Cardiac Surgery
3. Systemic or Inflammatory disease
4. Dialysis
5. Recent myocardial infarction (\< 21 days)
6. History of pericarditis
7. Patient taking part in any other device or drug study
8. Patient with known sensitivity or allergy to any of the device components
9. Pregnancy

Answer: A