Paroxysmal Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Robotic Control, Remote Control
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.
Interventions
DEVICEAblation
Atrial fibrillation ablation procedure
Sponsors
Hansen Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety-Incidence of Major Complications | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Procedural Success | 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. |
| Chronic Safety-Incidence of Major Complications | 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. |
Countries
Czechia, Denmark, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 150 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Left study for other reasons | 3 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Robotic Catheter Manipulation, Ablation |
|---|---|
| Age, Continuous | 60.2 years STANDARD_DEVIATION 11.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) White | 137 Participants |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 150 |
| other Total, other adverse events | 34 / 150 |
| serious Total, serious adverse events | 28 / 150 |
Outcome results
Primary
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.
Time frame: 91 - 365 days after the inital ablation procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Robotic Catheter Manipulation, Ablation | Effectiveness-Freedom From Symptomatic Atrial Fibrillation (AF), Atrial Flutter, and Atrial Tachycardia Episodes | Responders | 45 Participants |
| Robotic Catheter Manipulation, Ablation | Effectiveness-Freedom From Symptomatic Atrial Fibrillation (AF), Atrial Flutter, and Atrial Tachycardia Episodes | Failures | 60 Participants |
| Robotic Catheter Manipulation, Ablation | Effectiveness-Freedom From Symptomatic Atrial Fibrillation (AF), Atrial Flutter, and Atrial Tachycardia Episodes | Unknown | 45 Participants |
Primary
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.
Time frame: within 7 days of the ablation procedure nd the incidence of esophageal injury or pulmonary vein stenosis through 180 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Robotic Catheter Manipulation, Ablation | Safety-Incidence of Major Complications | Responders | 132 Participants |
| Robotic Catheter Manipulation, Ablation | Safety-Incidence of Major Complications | Failures | 13 Participants |
| Robotic Catheter Manipulation, Ablation | Safety-Incidence of Major Complications | Unknown | 5 Participants |
Secondary
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.
Time frame: Day 0
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Robotic Catheter Manipulation, Ablation | Acute Procedural Success | Responders | 142 Participants |
| Robotic Catheter Manipulation, Ablation | Acute Procedural Success | Failures | 8 Participants |
Secondary
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.
Time frame: 8 - 365 days post-procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Robotic Catheter Manipulation, Ablation | Chronic Safety-Incidence of Major Complications | Responders | 134 Participants |
| Robotic Catheter Manipulation, Ablation | Chronic Safety-Incidence of Major Complications | Failures | 16 Participants |