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

NCT01824394 | Terminated Phase 3 Results FDA Device

• 1 other identifier: reMARQable
• Study Type: interventional
• Target: 481
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Atrial Fibrillation

Keywords

nMARQ; Atrial Fibrillation; Drug Refractory; Radio Frequency

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

nMARQ Catheter

EXPERIMENTAL

nMARQ Catheter System

Device: nMARQ Navigation Catheters

NaviStar ThermoCool Catheters

ACTIVE COMPARATOR

THERMOCOOL® Navigational family of catheters

Device: NaviStar ThermoCool Catheters

Interventions

nMARQ Navigation Catheters DEVICE

nMARQ Catheter

NaviStar ThermoCool Catheters DEVICE

NaviStar ThermoCool Catheters

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Pre-procedure anticoagulation on warfarin, rivaroxaban, or apixaban.
• Age 18 years or older.
• Signed Patient Informed Consent Form (ICF).
• Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

You may not qualify if:

• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• Previous ablation for atrial fibrillation.
• Patients on amiodarone at any time during the past 3 months prior to enrollment.
• AF episodes lasting \> 7 days.
• Any cardiac surgery within the past 60 days (2 months).
• Any valvular cardiac surgical procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
• Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months).
• Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months).
• Documented left atrial thrombus on imaging.
• History of a documented thromboembolic event within the past one (1) year.
• Diagnosed atrial myxoma.
• Presence of implanted cardioverter defibrillator (ICD).
• 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.
• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
• Women who are pregnant (as evidenced by pregnancy test if subject is of child-bearing age and potential) or breast feeding.

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Megan Holden
• Organization: Biosense Webster, Inc.

mholden8@its.jnj.com

(949) 923-4700

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 4, 2013
• Study Start: April 1, 2013
• Primary Completion: November 26, 2017
• Study Completion: November 26, 2017
• Last Updated: February 4, 2025
• Results First Posted: December 12, 2018

Record last verified: 2025-01