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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01122173
Recruitment Status : Terminated
First Posted : May 13, 2010
Results First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Hansen Medical

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Paroxysmal Atrial Fibrillation
Intervention Device: Ablation
Enrollment 150
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Robotic Catheter Manipulation, Ablation
Hide Arm/Group 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.
Period Title: Overall Study
Started 150
Completed 141
Not Completed 9
Reason Not Completed
Lost to Follow-up             3
Withdrawal by Subject             3
Left study for other reasons             3
Arm/Group Title Robotic Catheter Manipulation, Ablation
Hide Arm/Group 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.
Overall Number of Baseline Participants 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 150 participants
60.2  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants
Female
58
  38.7%
Male
92
  61.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
137
  91.3%
More than one race
0
   0.0%
Unknown or Not Reported
13
   8.7%
1.Primary Outcome
Title Safety-Incidence of Major Complications
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robotic Catheter Manipulation, Ablation
Hide Arm/Group 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.
Overall Number of Participants Analyzed 150
Measure Type: Count of Participants
Unit of Measure: Participants
Responders
132
  88.0%
Failures
13
   8.7%
Unknown
5
   3.3%
2.Primary Outcome
Title Effectiveness-Freedom From Symptomatic Atrial Fibrillation (AF), Atrial Flutter, and Atrial Tachycardia Episodes
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robotic Catheter Manipulation, Ablation
Hide Arm/Group 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
Overall Number of Participants Analyzed 150
Measure Type: Count of Participants
Unit of Measure: Participants
Responders
45
  30.0%
Failures
60
  40.0%
Unknown
45
  30.0%
3.Secondary Outcome
Title Acute Procedural Success
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robotic Catheter Manipulation, Ablation
Hide Arm/Group 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.
Overall Number of Participants Analyzed 150
Measure Type: Count of Participants
Unit of Measure: Participants
Responders
142
  94.7%
Failures
8
   5.3%
4.Secondary Outcome
Title Chronic Safety-Incidence of Major Complications
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robotic Catheter Manipulation, Ablation
Hide Arm/Group 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.
Overall Number of Participants Analyzed 150
Measure Type: Count of Participants
Unit of Measure: Participants
Responders
134
  89.3%
Failures
16
  10.7%
Time Frame Adverse event data were collected one year following the procedure.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Robotic Catheter Manipulation, Ablation
Hide Arm/Group 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.
All-Cause Mortality
Robotic Catheter Manipulation, Ablation
Affected / at Risk (%)
Total   0/150 (0.00%)    
Hide Serious Adverse Events
Robotic Catheter Manipulation, Ablation
Affected / at Risk (%) # Events
Total   28/150 (18.67%)    
Cardiac disorders   
Arrhythmia †  18/150 (12.00%)  24
Angina pectoris †  1/150 (0.67%)  1
Heart block †  1/150 (0.67%)  1
Perforation of the cardiac muscle †  1/150 (0.67%)  1
Pericarditis †  1/150 (0.67%)  1
Arrhytmia Prophylaxis †  1/150 (0.67%)  1
Atrial fibrilation †  1/150 (0.67%)  1
Cardiac ablation †  3/150 (2.00%)  3
Gastrointestinal disorders   
Hiatus hernia †  1/150 (0.67%)  1
Infections and infestations   
Infection †  1/150 (0.67%)  1
Sepsis †  1/150 (0.67%)  1
Musculoskeletal and connective tissue disorders   
Back pain *  1/150 (0.67%)  1
Nervous system disorders   
Migraine *  1/150 (0.67%)  1
Renal and urinary disorders   
Urinary retention †  1/150 (0.67%)  1
Reproductive system and breast disorders   
Benign prostatic hypertrophy †  1/150 (0.67%)  1
Respiratory, thoracic and mediastinal disorders   
Pleurisy †  1/150 (0.67%)  2
Pulmonary effusion †  1/150 (0.67%)  2
Pharyngeal haematoma †  1/150 (0.67%)  1
Vascular disorders   
Bleeding (requiring treatment other than applying pressure & bandage) †  2/150 (1.33%)  2
Pseudoaneurysm †  1/150 (0.67%)  1
Fluid overload †  2/150 (1.33%)  2
Retroperitoneal haematoma †  1/150 (0.67%)  1
†
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Robotic Catheter Manipulation, Ablation
Affected / at Risk (%) # Events
Total   34/150 (22.67%)    
Cardiac disorders   
Arrhythmia †  27/150 (18.00%)  42
Infections and infestations   
Infection †  11/150 (7.33%)  13
†
Indicates events were collected by systematic assessment
Following the acquisition of Hansen, a decision was made to terminate the study. The PMA previously planned to be submitted year end 2016 will not be submitted.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Emir Deljkich/Sr. Director, Clinical Affairs
Organization: Auris Health, Inc.
Phone: 650-397-2677
EMail: emir.deljkich@aurisrobotics.com
Layout table for additonal information
Responsible Party: Hansen Medical
ClinicalTrials.gov Identifier: NCT01122173    
Other Study ID Numbers: HMP010
First Submitted: May 10, 2010
First Posted: May 13, 2010
Results First Submitted: August 14, 2018
Results First Posted: September 11, 2018
Last Update Posted: September 11, 2018