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

reMARQable 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).

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: nMARQ Navigation Catheters; Device: NaviStar ThermoCool Catheters

• Study Type: Interventional
• Enrollment (Actual): 481
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Ottignies, Belgium
    • Clinique Saint-Pierre Ottignies
  • Bonheiden
    • Imeldalaan, Bonheiden, Belgium, 2820
      • Imelda Ziekenhuis
• Czechia
  • Prague, Czechia, 15030
    • Nemocnice Na Homolce
• Hungary
  • Városmajor U
    • Budapest, Városmajor U, Hungary
      • Semmelweis University Heart and Vascular Center
• Italy
  • Asti, Italy
    • Ospedale Cardinal Massaia
  • Milano, Italy
    • Centro Cardiologico Monzino
  • Torino, Italy
    • A.O.U. Città della Salute e della Scienza di Torino - Ospedale San Giovanni Battista - Molinette
  • Bari
    • Acquaviva Delle Fonti, Bari, Italy, 70021
      • Ospedale Generale Regionale "F. Miulli"
• United Kingdom
  • Newcastle, United Kingdom
    • Freeman Hospital
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE3 9QP
      • Glenfield Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama Hospital
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Arizona Heart Rhythm Center
  • California
    • Los Angeles, California, United States, 90017
      • Good Samaritan Hospital Los Angeles
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital Presbyterian
    • Palo Alto, California, United States, 94304
      • Stanford Hospital and Clinics
    • Redwood City, California, United States, 94062
      • Sequoia Hospital
  • Florida
    • Jacksonville, Florida, United States, 32204
      • St. Vincent's Medical Center
    • New Smyrna Beach, Florida, United States, 32169
      • Florida Hospital Memorial Medical Center
    • Orlando, Florida, United States, 32803
      • Florida Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Hospital
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Central Baptist Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
    • Ridgewood, New Jersey, United States, 07450
      • Valley Hospital
    • Voorhees, New Jersey, United States, 08043
      • Our Lady of Lourdes Medical Center
  • New York
    • New York, New York, United States, 10016
      • New York University
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine, The
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center, The
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Heart Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Einstein Medical Center Philadelphia
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37203
      • Centennial Heart
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Research - St. David's
    • Houston, Texas, United States, 77030
      • St. Luke's Episcopal Hospital
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano
  • Utah
    • Murray, Utah, United States, 84157
      • Intermountain Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University Medical Center
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nMARQ Catheter; nMARQ Catheter System	Device: nMARQ Navigation Catheters
Active Comparator: NaviStar ThermoCool Catheters; THERMOCOOL® Navigational family of catheters	Device: NaviStar ThermoCool Catheters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Early Onset Primary Adverse Events	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	30 days post-procedure
Incidence of Early Onset Primary Adverse Events for the Intent-to-Treat and As-Treated Population	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	30 days post-procedure

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): November 26, 2017
• Study Completion (Actual): November 26, 2017

Study Registration Dates

• First Submitted: April 1, 2013
• First Submitted That Met QC Criteria: April 1, 2013
• First Posted (Estimate): April 4, 2013

Study Record Updates

• Last Update Posted (Actual): February 7, 2019
• Last Update Submitted That Met QC Criteria: January 18, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Radio Frequency; nMARQ; Drug Refractory
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: reMARQable

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes