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 @ 5:45 PM
Ignite Modification Date:
2025-12-24 @ 5:45 PM
NCT ID:
NCT03246568
Eligibility Criteria:
Inclusion Criteria:
1. Patients age is 18 years or greater;
2. Patients undergoing a first-time ablation procedure for AF;
3. Patients with persistent AF;
4. Persistent AF will be defined as a sustained episode lasting \> 7 days and less than 3 years.
5. Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication;
6. Symptomatic patients are those who have been aware of their AF at any time within the last 5 years prior to enrollment. 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.
7. At least one episode of persistent AF must have been documented by ECG, Holter, loop recorder, telemetry, trans telephonic monitoring (TTM), or implantable device within last 2 years of enrollment in this investigation.
Exclusion Criteria:
1. Patients with paroxysmal AF;
2. Paroxysmal AF will be defined as a sustained episode lasting \< 7 days.
3. Patients with long-standing persistent AF;
4. Long-standing persistent AF will be defined as a sustained episode lasting more than 3 years;
5. Patients for whom cardioversion or sinus rhythm will never be attempted/pursued;
6. Patients with AF felt to be secondary to an obvious reversible cause;
7. Patients with contraindications to systemic anticoagulation with heparin or warfarin or a direct thrombin inhibitor;
8. Patients with left atrial size ≥ 60 mm (2D echocardiography, parasternal long axis view);
9. Patients with more than 50% renal artery stenosis identified by duplex ultrasound or renal angiogram;
10. Patients in whom a renal stent has been in place for less than3 months;
11. Patients with prior renal artery stent placement, the artery segment beyond the stent margins must be able to accommodate treatments;
12. Patients with the treatment zone for denervation in the renal artery have areas of atheroma, severe fibromuscular dysplasia, calcification, and aneurysm that cannot be avoided;
13. Patients with renal dysfunction as demonstrated by an estimated glomerular filtration rate less than 45 mL/min per 1.73 m2 are excluded from both studies;
14. Pregnant women;
15. Participation in another interventional study;
16. Patient with contraindication to left ventricle catheterization by a retrograde aortic approach (eg mechanical aortic valve, severe aortic stenosis and aortic dissection).
17. Patient with systolic blood pressure \<100mmHg.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03246568
Study Brief:
Protocol Section:
NCT03246568