Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT01416935
Eligibility Criteria:
Inclusion Criteria:
* Subject is ≥ 18 years of age
* Subject must be diagnosed with Persistent and/or Longstanding Persistent Atrial fibrillation as classified by the HRS Guidelines 8 \[0\]
* Subject must be selected as a candidate to undergo the Cox- Maze procedure for ablation of atrial fibrillation
* The Cox Maze procedure may be done as a stand alone procedure or combined with other cardiac surgical procedures either via a median sternotomy or a right thoracotomy:
* Subject has a Left Ventricular Ejection Fraction (LVEF) ≥ 30%
* Subject would normally be prescribed Amiodarone as an anti arrhythmic medication post surgical ablation
* Subject is able and willing to provide written informed consent and HIPAA authorization
* Subject is able and willing to comply with all study requirements including attending all follow-up visits as deemed necessary by personal physician (cardiologist)
* Subject has a life expectancy of at least one year
Exclusion Criteria:
* Subject has undergone previous attempts at surgical Maze procedure or other AF operation, including surgical or catheter ablation Subject has an accessory pathways disorder (e.g. Wolff-Parkinson-White syndrome)
* Subject is in Class IV NYHA
* Subject has had a documented MI within 6 weeks prior to study enrollment
* Subject needs emergent cardiac surgery (i.e. cardiogenic shock)
* Subject has known carotid artery stenosis greater than 80%
* Subject has a current diagnosis of active systemic infection
* Subject is pregnant, planning to become pregnant within 12-14 months, or lactating
* Subject requires preoperative intra-aortic balloon pump or intravenous inotropes
* Subject has renal failure requiring dialysis
* Subject is diagnosed with hepatic failure
* Subject is on anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
* Subject has a known connective tissue disorder
* Subject is incarcerated
* Subject has previous or current therapy that could compromise tissue integrity including thoracic radiation, chemotherapy, long-term oral or injected steroids
* Subject is an intravenous drug and/or alcohol abuser
* Subject is participating in concomitant research studies of investigational products ( e.g. Appendage closure devices, atrial septal defect patches)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01416935
Study Brief:
Protocol Section:
NCT01416935