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Heart DiseasesPhase 3AFTXNCT00721149

NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study

A Phase 3 study testing Radiofrequency Ablation in people with Heart Diseases and Arrhythmia, run by Biosense Webster, Inc..

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This trial evaluates the safety and effectiveness of catheter ablation for PAF. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. At the time of this study, the NAVISTAR® THERMOCOOL® Catheter was FDA-approved for commercial distribution in the U.S. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Diseases, Arrhythmia, Atrial Fibrillation
What is being tested?
Radiofrequency Ablation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
Sep 2008to Dec 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to enrollment, one of which must be documented. Documentation may include electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.
  • Failure of at least one AAD for PAF [class I or III or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic PAF, or intolerable side effects due to AAD.
  • Signed Patient Informed Consent Form.
  • Age 18 years or older.
  • Able and willing to comply with all pre-, post- and follow-up testing and requirements.

Who cannot join

  • Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non- cardiac cause.
  • Previous ablation for atrial fibrillation.
  • Patients on amiodarone therapy at any time during the previous six (6) months.
  • AF episodes that last longer than 30 days and are terminated via cardioversion.
  • Any valvular cardiac surgical procedure.
  • CABG procedure within the last 180 days (six months).
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  • Awaiting cardiac transplantation or other cardiac surgery within the next 360 days (12 months).
  • Documented left atrial thrombus on imaging (e.g. TEE).
  • History of a documented thromboembolic event within the past one (1) year.
  • Diagnosed atrial myxoma.
  • Presence of implanted 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 (by history of menstrual period or pregnancy test if the history is considered unreliable).
  • Acute illness or active systemic infection or sepsis.
  • Unstable angina.
  • Myocardial infarction within the previous 60 days (two months).
  • LVEF < 40%.
  • History of blood clotting or bleeding abnormalities.
  • Contraindication to anticoagulation (i.e. heparin or warfarin).
  • Contraindication to CT/MRA procedure.
  • Life expectancy less than 360 days (12 months).
  • Enrollment in an investigational study evaluating another device or drug.
  • Uncontrolled heart failure or NYHA class III or IV heart failure.
  • Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
  • Presence of a condition that precludes vascular access.

About this study

This trial evaluates the safety and effectiveness of catheter ablation for PAF. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. At the time of this study, the NAVISTAR® THERMOCOOL® Catheter was FDA-approved for commercial distribution in the U.S. for treating patients with Type I atrial flutter and drug refractory monomorphic sustained ventricular tachycardia post myocardial infarction. The catheter was approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.

Being tested
Radiofrequency Ablation
Keywords
Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ablation, Non-randomized
Medical subject headings
Heart Diseases, Arrhythmias, Cardiac, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiofrequency AblationDevice

    The Biosense Webster® NAVISTAR THERMOCOOL Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.

Study groups in NCT00721149
Study groupRoleWhat they receive
NaviStar ThermoCoolExperimentalNot described
Receives: Device: Radiofrequency Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Subjects Who Exhibited no Documented Symptomatic Paroxysmal Atrial Fibrillation (PAF) Episodes From Study Day 91 Through Day 361.

    A subject who exhibited no documented symptomatic PAF episodes was one who 1) had 2 or fewer repeat ablations within 90 days of the initial ablation with investigational catheter; 2) had an addition of antiarrhythmic medication which was previously ineffective for atrial fibrillation and did not exceed the previous historical maximum dosage (24 hour total dose); 3) was on atrioventricular nodal blocking agents such as beta blockers and/or calcium channel blockers and might be maintained at the current dose (ie, did not exceed previous historical maximum dosage (24 hour total dose).

    Measured: From study day 91 through day 361

  2. The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Catheter-related Adverse Events.

    Catheter-related adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke, cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, hospitalization (initial and prolonged), and heart block.

    Measured: within 7 days of ablation procedure

Secondary outcomes (4)

  1. Percentage of Subjects Who Achieved Acute Success

    Acute success is defined as the confirmation of entrance block in all targeted pulmonary veins. Acute failure is defined as subjects who have a non-investigational catheter used for ablation of any atrial fibrillation targets or subjects who undergo more than 2 repeat ablation procedures or an ablation procedure beyond day 90.

    Measured: Day 91 - 361

  2. 24-hour Holter Data

    Measured: 1 year

  3. TTM Data

    Measured: 1 year

  4. Percentage of Subjects Who Responded to Quality of Life Assessment

    SF 36 Symptom Frequency and Severity Checklist

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionDec 2009
  4. Study completionDec 2009

Why it stopped: Enrollment stopped after CDRH Advisory Panel (Nov 20, 2008) recommended NAVISTAR® THERMOCOOL® catheter approval.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00721149
Sponsor's protocol ID
BWI03130TXA
Acronym
AFTX
Status last verified
Jan 2025
First submitted
21 Jul 2008
Last updated
4 Feb 2025
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radiofrequency Ablation in people with Heart Diseases and Arrhythmia, run by Biosense Webster, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects Who Exhibited no Documented Symptomatic Paroxysmal Atrial Fibrillation (PAF) Episodes From Study Day 91 Through Day 361. (time frame: From study day 91 through day 361). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00721149.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.

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