Education and Training

nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation

To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • device: nMARQ Navigation Catheters
  • device: NaviStar ThermoCool Catheters

Eligibility


Inclusion Criteria:

   1. Patients with symptomatic paroxysmal AF who have had at least one AF episode
   documented within one (1) year prior to enrollment. Documentation may include ECG,
   transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.

   2. Patients who have failed at least one antiarrhythmic drug (AAD; class I or III, or
   atrioventricular (AV) nodal blocking agents such as beta blockers and calcium channel
   blockers) as evidenced by recurrent symptomatic AF, or intolerance to the AAD.

   3. Pre-procedure anticoagulation on warfarin, rivaroxaban, or apixaban.

   4. Age 18 years or older.

   5. Signed Patient Informed Consent Form (ICF).

   6. Able and willing to comply with all pre-, post-, and follow-up testing and
   requirements.

Exclusion Criteria:

   1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac
   cause.

   2. Previous ablation for atrial fibrillation.

   3. Patients on amiodarone at any time during the past 3 months prior to enrollment.

   4. AF episodes lasting > 7 days.

   5. Any cardiac surgery within the past 60 days (2 months).

   6. Any valvular cardiac surgical procedure (i.e., ventriculotomy, atriotomy, and valve
   repair or replacement and presence of a prosthetic valve).

   7. Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months).

   8. Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12
   months).

   9. Documented left atrial thrombus on imaging.

10. History of a documented thromboembolic event within the past one (1) year.

11. Diagnosed atrial myxoma.

12. Presence of implanted cardioverter defibrillator (ICD).

13. Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or
   chronic obstructive pulmonary disease) or any other disease or malfunction of the
   lungs or respiratory system that produces chronic symptoms.

14. Significant congenital anomaly or medical problem that in the opinion of the
   investigator would preclude enrollment in this study.

15. Women who are pregnant (as evidenced by pregnancy test if subject is of child-bearing
   age and potential) or breast feeding.

16. Acute illness or active systemic infection or sepsis.

17. Unstable angina.

18. Myocardial infarction within the previous 60 days (2 months).

19. Left ventricular ejection fraction <40%.

20. History of blood clotting or bleeding abnormalities.

21. Contraindication to anticoagulation (i.e., heparin, dabigatran, Vitamin K Antagonists
   such as warfarin).

22. Life expectancy less than 365 days (12 months).

23. Enrollment in an investigational study evaluating another device or drug.

24. Uncontrolled heart failure or NYHA Class III or IV heart failure.

25. Presence of intramural thrombus, tumor or other abnormality that precludes catheter
   introduction or manipulation.

26. Presence of a condition that precludes vascular access.

27. Left atrial size >50 mm.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Linda Norton, RN, MSN, CCRC
650-725-5597
Not Recruiting