Use of the Hansen Medical System in Patients With Paroxysmal Atrial Fibrillation

August 14, 2018 updated by: Hansen Medical

A Prospective, Single Arm Study of the Hansen System for Introducing and Positioning RF Ablation Catheters in Subjects With Paroxysmal Atrial Fibrillation

The purpose of this study is to assess the safety and performance of the Hansen Medical Sensei Robotic System and Artisan Catheter when used to robotically manipulate RF ablation catheters for the treatment of paroxysmal atrial fibrillation (irregular heartbeats originating in the upper chambers of the heart).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Subjects who satisfy the inclusion and exclusion criteria will be treated with an RF ablation catheter and Artisan guide catheters controlled by the Sensei X Robotic Catheter System.

Subject will be followed for a period of one year post ablation procedure.

Follow up visit time frames will be conducted at 7-day, 30-day, 90-day, 180-day and 365-day.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Prague, Czechia
        • IKEM, Dept of Cardiology
  • Denmark
      • Hellerup, Denmark, 2900
        • Gentofte University Hospital
  • Spain
      • Madrid, Spain
        • Hospital Universitario Madrid Montepríncipe
  • United Kingdom
      • Oxford, United Kingdom, OX39DU
        • John Radcliff Hospital
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Banner Heart Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital and Medical Center
      • Livingston, New Jersey, United States, 07039
        • Saint Barnabas Heart Center
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Memorial Hospital
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Health Arlington Memorial/Heart Place
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Research Foundation (TCARF)
      • Houston, Texas, United States, 77030
        • Houston Methodist Research Institute
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Univeristy of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects with paroxysmal atrial fibrillation who have had two or more spontaneously terminating episodes of atrial fibrillation, that last longer than 30 seconds and shorter than 7 days, in the nine months prior to enrollment. At least one episode must be documented with EKG, TTM, Holter monitor, or telemetry.
  2. Failure of at least one Class I - IV anti-arrhythmic drug (AAD) for PAF as evidenced by recurrent symptomatic PAF, or intolerable side effects due to AADs. AADs are defined in Appendix B.
  3. Signed informed consent.
  4. Age 18 years or older
  5. Able and willing to comply with all pre-, post-, and follow-up testing and requirements.

Exclusion Criteria:

  1. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
  2. Previous ablation for atrial fibrillation.
  3. Atrial fibrillation episodes that last less than 7 days and are terminated by cardioversion.
  4. Previous valvular cardiac surgery procedure.
  5. Cardiac artery bypass graft procedure within the previous 180 days.
  6. Previous septal defect repair.
  7. Expecting cardiac transplantation or other cardiac surgery within the next 180 days.
  8. Coronary PTCA/stenting within the previous 180 days.
  9. Documented left atrial thrombus on ultrasound imaging (TEE).
  10. Documented history of a thrombo-embolic event within the previous 365 days.
  11. Diagnosed atrial myxoma.
  12. Presence of an implanted ICD.
  13. Presence of permanent pacing leads.
  14. Significant restrictive, constrictive, or chronic obstructive pulmonary disease or any other disease or malfunction of the lungs or respiratory system with chronic symptoms.
  15. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
  16. Women who are pregnant.
  17. Acute illness or active infection at time of index procedure documented by either pain, fever, drainage, positive culture and/or leukocytosis (WBC > 11,000 mm3) for which antibiotics have been or will be prescribed.
  18. Creatinine > 2.5 mg/dl (or > 221 µmol/L).
  19. Unstable angina.
  20. Myocardial infarction within the previous 60 days.
  21. Left ventricular ejection fraction less than 40%
  22. History of blood clotting or bleeding abnormalities.
  23. Contraindication to anticoagulation medications.
  24. Contraindication to computed tomography or magnetic resonance imaging procedures.
  25. Life expectancy less than 1 year.
  26. Enrollment in another investigational study.
  27. Uncontrolled heart failure (NYHA class III or IV heart failure).
  28. Presence of an intramural thrombus, tumor, or other abnormality that precludes catheter introduction or positioning.
  29. Presence of a condition that precludes vascular access.
  30. Left atrial size ≥ 50mm.
  31. INR greater than 3.0 within 24 hours of procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Robotic catheter manipulation, Ablation
To evaluate the safety and effectiveness of the family of Artisan guide catheters when used to remotely introduce and position commercially available cardiac RF ablation catheters to treat subjects with paroxysmal atrial fibrillation.
Device: Ablation
Atrial fibrillation ablation procedure
Other Names:
  • Sensei X Robotic Catheter System
  • Artisan Control Catheter
  • RF Ablation Catheters

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety-Incidence of Major Complications
Time Frame: within 7 days of the ablation procedure nd the incidence of esophageal injury or pulmonary vein stenosis through 180 days
The primary safety endpoint was defined as the incidence of major complications, including all early onset (within 7 days of the ablation procedure) major complications, and the incidence of esophageal injury or pulmonary vein stenosis through 180 days.
within 7 days of the ablation procedure nd the incidence of esophageal injury or pulmonary vein stenosis through 180 days
Effectiveness-Freedom From Symptomatic Atrial Fibrillation (AF), Atrial Flutter, and Atrial Tachycardia Episodes
Time Frame: 91 - 365 days after the inital ablation procedure
The primary effectiveness endpoint is chronic success as demonstrated by the freedom from symptomatic atrial arrhythmia from days 91 to 365.
91 - 365 days after the inital ablation procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute Procedural Success
Time Frame: Day 0
Acute procedural success is defined as the successful ablation of at least three of four pulmonary veins as shown by pulmonary vein entrance block per vein during the initial ablation procedure. A subject is considered to be an acute procedural failure if acute procedural success cannot be obtained by using the Hansen system and, as a result, manual manipulation is needed to complete the ablation procedure with the ablation catheter.
Day 0
Chronic Safety-Incidence of Major Complications
Time Frame: 8 - 365 days post-procedure
Chronic safety is defined as the incidence of Major Complications during the period from 8 - 365 days following the initial ablation procedure (excluding pulmonary vein stenosis and atrio-esophageal fistula from 8 - 180 days, which are included in the primary safety endpoint). The incidence of pulmonary vein stenosis and atrioesophageal fistula is included during the period from 181 - 365 days.
8 - 365 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hansen Medical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrea Natale, M.D., Texas Cardiac Arrhythmia Research Foundation
  • Principal Investigator: Joseph Gallinghouse, M.D., Texas Cardiac Arrhythmia Research Foundation
  • Study Director: Brenda Cayme, RN., BSN, Hansen Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2010

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HMP010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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