NAVISTAR® THERMOCOOL® Catheter Post Approval Registry

NCT00964392 | Completed Phase 4 Results

• 1 other identifier: PMA #P030031/S014
• Study Type: interventional
• Target: 437
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this registry is to provide additional corroborative short-term safety and long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters in the treatment of symptomatic Paroxysmal Atrial Fibrillation (PAF).

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• The Percentage of Subjects Experiencing Primary Adverse Events Within Seven Days of the Ablation Procedure.

  The primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient ischemic attack (TIA), Stroke/Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac tamponade, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular access complications, Pulmonary edema, Hospitalization (including initial and prolonged, excluding those hospitalizations solely due to pre-existing arrhythmia recurrence), Heart block. Pulmonary vein stenosis (defined as ≥70% diameter reduction) and atrio-esophageal fistula occurring more than 7 days post-procedure shall be deemed a Primary AE. The primary endpoint for the Post-Approval Registry is a comparison of the 7-day primary AE rate against a performance criterion of 16 %. The 16% performance criterion is based on literature data and discussion with the FDA per IDE G030236.

  Seven days post ablation procedure

Secondary Outcomes (1)

• Percentage of Subjects Experienced Serious Adverse Events.

  First study day to 5 year post-ablation

Study Arms (2)

More-Experienced Physicians (MEP)

EXPERIMENTAL

Physicians who perform greater than or equal to 50 atrial fibrillation ablation procedures per year.

Procedure: Atrial fibrillation ablation

Less-Experienced Physicians (LEP)

EXPERIMENTAL

Physicians who perform less than 50 atrial fibrillation ablation procedures per year.

Procedure: Atrial fibrillation ablation

Interventions

Atrial fibrillation ablation PROCEDURE

Radiofrequency ablation

Less-Experienced Physicians (LEP); More-Experienced Physicians (MEP)

Eligibility Criteria

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

You may qualify if:

• Candidates for this registry must meet ALL of the following criteria:
• Patients with drug refractory recurrent symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to enrollment and one AF episode documented within the one (1) year prior to enrollment. Documentation may include electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.
• Failure of at least one AAD for AF (class I or III or AV nodal blocking agent such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic PAF, or intolerable side effects.
• Age 18 years or older.
• Able and willing to comply with all pre-, post- and follow-up testing and requirements.
• Signed Patient Informed Consent Form.

You may not qualify if:

• Candidates will be excluded from the registry if any of the following conditions apply:
• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• AF episodes that last longer than 30 days and are terminated via cardioversion.
• CABG procedure within the last six (6) months.
• Awaiting cardiac transplantation or other cardiac surgery.
• Documented left atrial thrombus on imaging (i.e., TEE, ICE, CT, or MRA).
• History of a documented thromboembolic event within the past one (1) year.
• Diagnosed atrial myxoma.
• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this registry.
• Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable).
• Acute illness or active systemic infection or sepsis.
• Unstable angina.
• Uncontrolled heart failure.
• Myocardial infarction within the previous two (2) months.
• History of blood clotting or bleeding abnormalities.

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: Robert Stagg, Clinical Franchise
• Organization: Biosense Webster, Inc.

RStagg@its.jnj.com

(800) 729-9010

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2009
• First Posted: August 24, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: January 5, 2018
• Last Updated: February 4, 2025
• Results First Posted: April 26, 2017

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share