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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Biosense Webster, Inc.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01824394
First received: April 1, 2013
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention Phase
Atrial Fibrillation
Device: nMARQ Navigation Catheters
Device: NaviStar ThermoCool Catheters
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: reMARQable nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • Early-onset primary adverse events [ Time Frame: 7 Days ] [ Designated as safety issue: Yes ]
    Incidence of early-onset primary adverse events within 7 days of the atrial fibrillation ablation procedure.

  • Incidence of arrhythmia [ Time Frame: 3-12 Months ] [ Designated as safety issue: No ]
    Freedom from documented, symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes based on electrocardiographic data through the effectiveness evaluation period (3-12 months follow-up post ablation procedure) in the intention to treat (ITT) population as randomized.


Estimated Enrollment: 400
Study Start Date: March 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nMARQ Catheter
nMARQ Catheter System
Device: nMARQ Navigation Catheters
Active Comparator: NaviStar ThermoCool Catheters
THERMOCOOL® Navigational family of catheters
Device: NaviStar ThermoCool Catheters

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. Age 18 years or older.
  4. Signed Patient Informed Consent Form (ICF).
  5. 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) or valvular cardiac surgical procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
  6. Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months).
  7. Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months).
  8. Documented left atrial thrombus on imaging.
  9. History of a documented thromboembolic event within the past one (1) year.
  10. Diagnosed atrial myxoma.
  11. Presence of implanted cardioverter defibrillator (ICD).
  12. 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.
  13. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
  14. Women who are pregnant (as evidenced by pregnancy test if subject is of child-bearing age and potential) or breast feeding.
  15. Acute illness or active systemic infection or sepsis.
  16. Unstable angina.
  17. Myocardial infarction within the previous 60 days (2 months).
  18. Left ventricular ejection fraction <40%.
  19. History of blood clotting or bleeding abnormalities.
  20. Contraindication to anticoagulation (i.e., heparin, dabigatran, Vitamin K Antagonists such as warfarin).
  21. Life expectancy less than 365 days (12 months).
  22. Enrollment in an investigational study evaluating another device or drug.
  23. Uncontrolled heart failure or NYHA Class III or IV heart failure.
  24. Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
  25. Presence of a condition that precludes vascular access.
  26. Left atrial size >50 mm.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01824394

Contacts
Contact: Josh Der (909) 839-8843

  Show 30 Study Locations
Sponsors and Collaborators
Biosense Webster, Inc.
  More Information

No publications provided

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01824394     History of Changes
Other Study ID Numbers: reMARQable
Study First Received: April 1, 2013
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Biosense Webster, Inc.:
nMARQ
Atrial Fibrillation
Drug Refractory
Radio Frequency

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014