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

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ClinicalTrials.gov Identifier: NCT01824394
Recruitment Status : Terminated (Business Decision)
First Posted : April 4, 2013
Results First Posted : December 12, 2018
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Tracking Information
First Submitted Date  ICMJE April 1, 2013
First Posted Date  ICMJE April 4, 2013
Results First Submitted Date  ICMJE November 26, 2018
Results First Posted Date  ICMJE December 12, 2018
Last Update Posted Date February 7, 2019
Actual Study Start Date  ICMJE April 1, 2013
Actual Primary Completion Date November 26, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
  • Number of Participants With Early Onset Primary Adverse Events [ Time Frame: 30 days post-procedure ]
    The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs
  • Incidence of Early Onset Primary Adverse Events for the Intent-to-Treat and As-Treated Population [ Time Frame: 30 days post-procedure ]
    The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2013)
  • Primary Safety Endpoint [ Time Frame: 7 Days ]
    Incidence of early-onset primary adverse events within 7 days of the atrial fibrillation ablation procedure.
  • Primary Effectiveness Endpoint [ Time Frame: 3-12 Months ]
    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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation
Official Title  ICMJE reMARQable nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Device: nMARQ Navigation Catheters
  • Device: NaviStar ThermoCool Catheters
Study Arms  ICMJE
  • Experimental: nMARQ Catheter
    nMARQ Catheter System
    Intervention: Device: nMARQ Navigation Catheters
  • Active Comparator: NaviStar ThermoCool Catheters
    THERMOCOOL® Navigational family of catheters
    Intervention: Device: NaviStar ThermoCool Catheters
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 9, 2018)
481
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2013)
400
Actual Study Completion Date  ICMJE November 26, 2017
Actual Primary Completion Date November 26, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Czechia,   Hungary,   Italy,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01824394
Other Study ID Numbers  ICMJE reMARQable
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biosense Webster, Inc.
Study Sponsor  ICMJE Biosense Webster, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Biosense Webster, Inc.
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP