Trial Outcomes & Findings for Use of the Hansen Medical System in Patients With Paroxysmal Atrial Fibrillation (NCT NCT01122173)
NCT ID: NCT01122173
Last Updated: 2018-09-11
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
within 7 days of the ablation procedure nd the incidence of esophageal injury or pulmonary vein stenosis through 180 days
Results posted on
2018-09-11
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
150
|
|
Overall Study
COMPLETED
|
141
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Left study for other reasons
|
3
|
Baseline Characteristics
Use of the Hansen Medical System in Patients With Paroxysmal Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Robotic Catheter Manipulation, Ablation
n=150 Participants
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.
|
|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
137 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 7 days of the ablation procedure nd the incidence of esophageal injury or pulmonary vein stenosis through 180 daysThe 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.
Outcome measures
| Measure |
Robotic Catheter Manipulation, Ablation
n=150 Participants
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.
|
|---|---|
|
Safety-Incidence of Major Complications
Responders
|
132 Participants
|
|
Safety-Incidence of Major Complications
Failures
|
13 Participants
|
|
Safety-Incidence of Major Complications
Unknown
|
5 Participants
|
PRIMARY outcome
Timeframe: 91 - 365 days after the inital ablation procedureThe primary effectiveness endpoint is chronic success as demonstrated by the freedom from symptomatic atrial arrhythmia from days 91 to 365.
Outcome measures
| Measure |
Robotic Catheter Manipulation, Ablation
n=150 Participants
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.
|
|---|---|
|
Effectiveness-Freedom From Symptomatic Atrial Fibrillation (AF), Atrial Flutter, and Atrial Tachycardia Episodes
Responders
|
45 Participants
|
|
Effectiveness-Freedom From Symptomatic Atrial Fibrillation (AF), Atrial Flutter, and Atrial Tachycardia Episodes
Failures
|
60 Participants
|
|
Effectiveness-Freedom From Symptomatic Atrial Fibrillation (AF), Atrial Flutter, and Atrial Tachycardia Episodes
Unknown
|
45 Participants
|
SECONDARY outcome
Timeframe: Day 0Acute 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.
Outcome measures
| Measure |
Robotic Catheter Manipulation, Ablation
n=150 Participants
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.
|
|---|---|
|
Acute Procedural Success
Responders
|
142 Participants
|
|
Acute Procedural Success
Failures
|
8 Participants
|
SECONDARY outcome
Timeframe: 8 - 365 days post-procedureChronic 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.
Outcome measures
| Measure |
Robotic Catheter Manipulation, Ablation
n=150 Participants
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.
|
|---|---|
|
Chronic Safety-Incidence of Major Complications
Responders
|
134 Participants
|
|
Chronic Safety-Incidence of Major Complications
Failures
|
16 Participants
|
Adverse Events
Robotic Catheter Manipulation, Ablation
Serious events: 28 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Robotic Catheter Manipulation, Ablation
n=150 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
12.0%
18/150 • Number of events 24 • Adverse event data were collected one year following the procedure.
|
|
Cardiac disorders
Angina pectoris
|
0.67%
1/150 • Number of events 1 • Adverse event data were collected one year following the procedure.
|
|
Infections and infestations
Infection
|
0.67%
1/150 • Number of events 1 • Adverse event data were collected one year following the procedure.
|
|
Infections and infestations
Sepsis
|
0.67%
1/150 • Number of events 1 • Adverse event data were collected one year following the procedure.
|
|
Cardiac disorders
Heart block
|
0.67%
1/150 • Number of events 1 • Adverse event data were collected one year following the procedure.
|
|
Cardiac disorders
Perforation of the cardiac muscle
|
0.67%
1/150 • Number of events 1 • Adverse event data were collected one year following the procedure.
|
|
Cardiac disorders
Pericarditis
|
0.67%
1/150 • Number of events 1 • Adverse event data were collected one year following the procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.67%
1/150 • Number of events 2 • Adverse event data were collected one year following the procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary effusion
|
0.67%
1/150 • Number of events 2 • Adverse event data were collected one year following the procedure.
|
|
Vascular disorders
Bleeding (requiring treatment other than applying pressure & bandage)
|
1.3%
2/150 • Number of events 2 • Adverse event data were collected one year following the procedure.
|
|
Vascular disorders
Pseudoaneurysm
|
0.67%
1/150 • Number of events 1 • Adverse event data were collected one year following the procedure.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.67%
1/150 • Number of events 1 • Adverse event data were collected one year following the procedure.
|
|
Reproductive system and breast disorders
Benign prostatic hypertrophy
|
0.67%
1/150 • Number of events 1 • Adverse event data were collected one year following the procedure.
|
|
Cardiac disorders
Arrhytmia Prophylaxis
|
0.67%
1/150 • Number of events 1 • Adverse event data were collected one year following the procedure.
|
|
Cardiac disorders
Atrial fibrilation
|
0.67%
1/150 • Number of events 1 • Adverse event data were collected one year following the procedure.
|
|
Cardiac disorders
Cardiac ablation
|
2.0%
3/150 • Number of events 3 • Adverse event data were collected one year following the procedure.
|
|
Vascular disorders
Fluid overload
|
1.3%
2/150 • Number of events 2 • Adverse event data were collected one year following the procedure.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.67%
1/150 • Number of events 1 • Adverse event data were collected one year following the procedure.
|
|
Nervous system disorders
Migraine
|
0.67%
1/150 • Number of events 1 • Adverse event data were collected one year following the procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haematoma
|
0.67%
1/150 • Number of events 1 • Adverse event data were collected one year following the procedure.
|
|
Vascular disorders
Retroperitoneal haematoma
|
0.67%
1/150 • Number of events 1 • Adverse event data were collected one year following the procedure.
|
|
Renal and urinary disorders
Urinary retention
|
0.67%
1/150 • Number of events 1 • Adverse event data were collected one year following the procedure.
|
Other adverse events
| Measure |
Robotic Catheter Manipulation, Ablation
n=150 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
18.0%
27/150 • Number of events 42 • Adverse event data were collected one year following the procedure.
|
|
Infections and infestations
Infection
|
7.3%
11/150 • Number of events 13 • Adverse event data were collected one year following the procedure.
|
Additional Information
Emir Deljkich/Sr. Director, Clinical Affairs
Auris Health, Inc.
Phone: 650-397-2677
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place