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NAVISTAR® THERMOCOOL® Catheter Post Approval Registry | Clinical Trials | Clareo Health

COMPLETEDPHASE4

NAVISTAR® THERMOCOOL® Catheter Post Approval Registry

NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation - Post Approval Registry

NCT00964392•Biosense Webster, Inc.

View on ClinicalTrials.gov

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).

Detailed Description

This registry is a prospective, multi-center, non-randomized post approval evaluation comprised of two (2) registry arms with independent hypotheses. The registry arms are defined as; Arm 1) physicians who perform greater than or equal to 50 atrial fibrillation ablation procedures per year and Arm 2) physicians who perform less than 50 atrial fibrillation ablation procedures per year. Subjects with drug refractory recurrent symptomatic PAF will be considered for this post approval registry. This registry will be conducted at up to 40 centers in a minimum of 381 evaluable subjects. The devices are currently FDA approved for commercial distribution under PMA #P030031/S11.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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).
+9 more criteria

Key Dates

Start Date

September 1, 2009

Primary Completion Date

September 1, 2013

Completion Date

January 5, 2018

Last Updated

February 4, 2025

Enrollment

437

ACTUAL participants

Conditions

Paroxysmal Atrial Fibrillation

Interventions

Atrial fibrillation ablation

PROCEDURE

Burst Stimulation for Paroxysmal Atrial Fibrillation

NCT07281898

Paroxysmal Atrial Fibrillation

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RECRUITINGPHASE4

Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias

NCT06765356

Persistent Atrial FibrillationParoxysmal Atrial Fibrillation+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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NAVISTAR® THERMOCOOL® Catheter Post Approval Registry

Inclusion Criteria

Exclusion Criteria

Burst Stimulation for Paroxysmal Atrial Fibrillation

Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias

VOLT CE Mark Study

Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)

ADVENT Post Approval Study

Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation