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

This study is currently recruiting participants.
Verified March 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: March 7, 2014
Last verified: March 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01824394

Contacts
Contact: Josh Der (909) 839-8843

Locations
United States, California
Good Samaritan Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90017
Contact: Young Park    213-977-4175      
Principal Investigator: Anil Bhandari, MD         
United States, Florida
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Leann Goodwin    407-303-8059      
Principal Investigator: Scott Pollak, MD         
United States, Georgia
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States, 30309
Contact: Laura Murrieta    404-605-3074      
Principal Investigator: Andrew Wickliffe, MD         
United States, Kansas
University of Kansas Hospital Recruiting
Kansas City, Kansas, United States, 66160
Contact: Melissa Jaeger    913-588-9627      
Principal Investigator: Dhanunjaya Lakkireddy, MD         
United States, Kentucky
Central Baptist Hospital Recruiting
Lexington, Kentucky, United States, 40503
Contact: Melody Muir    859-260-6429      
Principal Investigator: Gery Tomassoni, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Mai Doan    617-726-0280      
Principal Investigator: Moussa Mansour, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Christine Pellegrini    617-732-5241      
Principal Investigator: Gregory Michaud, MD         
United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Scott Kerwin    612-863-8200      
Principal Investigator: Daniel Melby, MD         
United States, New Jersey
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Deborah Brunetti    973-971-5951      
Principal Investigator: Jonathan S Sussman, MD         
United States, New York
Mount Sinai School of Medicine, The Recruiting
New York, New York, United States, 10029
Contact: Lance Glickman    212-824-8930      
Principal Investigator: Vivek Reddy, MD         
New York University Recruiting
New York, New York, United States, 10016
Contact: Laura Kuznekoff    212-263-7704      
Principal Investigator: Larry Chinitz, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Debbie Hickey    919-668-3524      
Principal Investigator: James P. Daubert, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Danielle Schaffer    216-445-6917      
Principal Investigator: Lindsay Bruce, MD         
Ohio State University Medical Center, The Recruiting
Columbus, Ohio, United States, 43210
Contact: Keri Baia    614-685-4621      
Principal Investigator: Emile Daoud, MD         
United States, Pennsylvania
University of Pennsylvania Health System Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Tony Killian    215-615-5299      
Principal Investigator: David Frankel, MD         
United States, Texas
Texas Cardiac Arrhythmia Research - St. David's Recruiting
Austin, Texas, United States, 78705
Contact: Deb Cardinal    512-458-9410      
Principal Investigator: Rodney Horton, MD         
The Heart Hospital Baylor Plano Recruiting
Plano, Texas, United States, 75093
Contact: Kunigal Khanum    469-814-4732      
Principal Investigator: J. Brian DeVille, MD         
United States, Virginia
Virginia Commonwealth University Medical Center Recruiting
Richmond, Virginia, United States, 23219
Contact: Kim Hall    804-828-4700      
Principal Investigator: Kenneth Ellenbogen, MD         
Italy
Ospedale Generale Regionale "F. Miulli" Recruiting
Acquaviva Delle Fonti, Strada, Italy, 70021
Contact: Mario Petruzzi    +39 32 06 975 496      
Principal Investigator: Massimo Grimaldi, MD         
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: March 7, 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 April 17, 2014