Back to resultsUse of the Hansen Medical System in Patients With Paroxysmal Atrial Fibrillation
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Atrial Fibrillation, Robotic Control, Remote Control
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Banner Heart Hospital
- Mayo Clinic
- Englewood Hospital and Medical Center
- Saint Barnabas Heart Center
- Greenville Memorial Hospital
- Texas Health Arlington Memorial/Heart Place
- Texas Cardiac Arrhythmia Research Foundation (TCARF)
- Houston Methodist Research Institute
- Univeristy of Virginia
- IKEM, Dept of Cardiology
- Gentofte University Hospital
- Hospital Universitario Madrid Montepríncipe
- John Radcliff Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Robotic catheter manipulation, Ablation
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01122173
Brief Title
Use of the Hansen Medical System in Patients With Paroxysmal Atrial Fibrillation
Official Title
A Prospective, Single Arm Study of the Hansen System for Introducing and Positioning RF Ablation Catheters in Subjects With Paroxysmal Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Study Start Date
July 2013 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hansen Medical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
Atrial Fibrillation, Robotic Control, Remote Control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robotic catheter manipulation, Ablation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Ablation
Other Intervention Name(s)
Sensei X Robotic Catheter System, Artisan Control Catheter, RF Ablation Catheters
Intervention Description
Atrial fibrillation ablation procedure
Primary Outcome Measure Information:
Title
Safety-Incidence of Major Complications
Description
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.
Time Frame
within 7 days of the ablation procedure nd the incidence of esophageal injury or pulmonary vein stenosis through 180 days
Title
Effectiveness-Freedom From Symptomatic Atrial Fibrillation (AF), Atrial Flutter, and Atrial Tachycardia Episodes
Description
The primary effectiveness endpoint is chronic success as demonstrated by the freedom from symptomatic atrial arrhythmia from days 91 to 365.
Time Frame
91 - 365 days after the inital ablation procedure
Secondary Outcome Measure Information:
Title
Acute Procedural Success
Description
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.
Time Frame
Day 0
Title
Chronic Safety-Incidence of Major Complications
Description
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.
Time Frame
8 - 365 days post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Gallinghouse, M.D.
Organizational Affiliation
Texas Cardiac Arrhythmia Research Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea Natale, M.D.
Organizational Affiliation
Texas Cardiac Arrhythmia Research Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brenda Cayme, RN., BSN
Organizational Affiliation
Hansen Medical, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Banner Heart Hospital
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Saint Barnabas Heart Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Texas Health Arlington Memorial/Heart Place
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation (TCARF)
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Houston Methodist Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univeristy of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
IKEM, Dept of Cardiology
City
Prague
Country
Czechia
Facility Name
Gentofte University Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Hospital Universitario Madrid Montepríncipe
City
Madrid
Country
Spain
Facility Name
John Radcliff Hospital
City
Oxford
ZIP/Postal Code
OX39DU
Country
United Kingdom
12. IPD Sharing Statement
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Use of the Hansen Medical System in Patients With Paroxysmal Atrial Fibrillation
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