Paroxysmal Atrial FibrillationNCT01122173
Use of the Hansen Medical System in Patients With Paroxysmal Atrial Fibrillation
A study testing Ablation in people with Paroxysmal Atrial Fibrillation, run by Hansen Medical at 13 sites in 5 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 13 sitesin 5 countries
- Study dates
- Jul 2013to Apr 2017
- Phase
- Interventional
- 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
- 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.
- 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.
- Signed informed consent.
- 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.
- Atrial fibrillation episodes that last less than 7 days and are terminated by cardioversion.
- Previous valvular cardiac surgery procedure.
- Cardiac artery bypass graft procedure within the previous 180 days.
- Previous septal defect repair.
Show all 31Show fewer
- Expecting cardiac transplantation or other cardiac surgery within the next 180 days.
- Coronary PTCA/stenting within the previous 180 days.
- Documented left atrial thrombus on ultrasound imaging (TEE).
- Documented history of a thrombo-embolic event within the previous 365 days.
- Diagnosed atrial myxoma.
- Presence of an implanted ICD.
- Presence of permanent pacing leads.
- Significant restrictive, constrictive, or chronic obstructive pulmonary disease or any other disease or malfunction of the lungs or respiratory system with 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.
- 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.
- Creatinine > 2.5 mg/dl (or > 221 µmol/L).
- Unstable angina.
- Myocardial infarction within the previous 60 days.
- Left ventricular ejection fraction less than 40%
- History of blood clotting or bleeding abnormalities.
- Contraindication to anticoagulation medications.
- Contraindication to computed tomography or magnetic resonance imaging procedures.
- Life expectancy less than 1 year.
- Enrollment in another investigational study.
- Uncontrolled heart failure (NYHA class III or IV heart failure).
- Presence of an intramural thrombus, tumor, or other abnormality that precludes catheter introduction or positioning.
- Presence of a condition that precludes vascular access.
- Left atrial size ≥ 50mm.
- INR greater than 3.0 within 24 hours of procedure.
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
United States9 sites
Texas Health Arlington Memorial/Heart Place
Arlington, Texas, 76012
Texas Cardiac Arrhythmia Research Foundation (TCARF)
Austin, Texas, 78705
Univeristy of Virginia
Charlottesville, Virginia, 22908
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
Greenville Memorial Hospital
Greenville, South Carolina, 29605
Houston Methodist Research Institute
Houston, Texas, 77030
Saint Barnabas Heart Center
Livingston, New Jersey, 07039
Banner Heart Hospital
Mesa, Arizona, 85206
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: 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).
Read the 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.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Ablation
- Keywords
- Atrial Fibrillation, Robotic Control, Remote Control
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationDevice
Also called Sensei X Robotic Catheter System, Artisan Control Catheter, RF Ablation Catheters
Atrial fibrillation ablation procedure
| Study group | Role | What they receive |
|---|---|---|
| Robotic catheter manipulation, Ablation | Experimental | 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. Receives: Device: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety-Incidence of Major Complications
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.
Measured: 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
The primary effectiveness endpoint is chronic success as demonstrated by the freedom from symptomatic atrial arrhythmia from days 91 to 365.
Measured: 91 - 365 days after the inital ablation procedure
Secondary outcomes (2)
Acute Procedural Success
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.
Measured: Day 0
Chronic Safety-Incidence of Major Complications
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.
Measured: 8 - 365 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startJul 2013
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hansen Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Gallinghouse, M.D., Principal investigator, Texas Cardiac Arrhythmia Research FoundationAndrea Natale, M.D., Principal investigator, Texas Cardiac Arrhythmia Research FoundationBrenda Cayme, RN., BSN, Study director, Hansen Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122173
- Sponsor's protocol ID
- HMP010
- Status last verified
- Aug 2018
- First submitted
- 10 May 2010
- Last updated
- 11 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm Study of the Hansen System for Introducing and Positioning RF Ablation Catheters in Subjects With Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01122173
- Acronym / sponsor ID
- HMP010
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Robotic Control, Remote Control
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hansen MedicalIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 13 May 2010 (estimated)
- Results
- Posted 11 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic catheter manipulation, Ablation | Experimental | Device: AblationTo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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.
- Signed informed consent.
- Age 18 years or older
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements.
Key exclusion criteria (31 listed)
- Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- Previous ablation for atrial fibrillation.
- Atrial fibrillation episodes that last less than 7 days and are terminated by cardioversion.
- Previous valvular cardiac surgery procedure.
- Cardiac artery bypass graft procedure within the previous 180 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AblationAlso: Sensei X Robotic Catheter System, Artisan Control Catheter, RF Ablation CathetersAtrial fibrillation ablation procedure | Device | Robotic catheter manipulation, Ablation |
Primary outcome
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.
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.
2 secondary outcomes
Acute Procedural Success
Time frame: Day 0
Chronic Safety-Incidence of Major Complications
Time frame: 8 - 365 days post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Paroxysmal Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
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A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
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A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
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A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
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Not yet recruitingObservational study
Catheter Ablation Using a Novel Navigation and Imaging System
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Gallinghouse, M.D. principal investigator
Texas Cardiac Arrhythmia Research Foundation
Andrea Natale, M.D. principal investigator
Texas Cardiac Arrhythmia Research Foundation
Brenda Cayme, RN., BSN study director
Hansen Medical, Inc.
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation in people with Paroxysmal Atrial Fibrillation, run by Hansen Medical at 13 sites in 5 countries.
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 31 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 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Czechia, Denmark, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2018). 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?
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 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?
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 11 Sep 2018.