NCT01122173

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
5 countries

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2010

Completed
3.1 years until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 11, 2018

Completed
Last Updated

September 11, 2018

Status Verified

August 1, 2018

Enrollment Period

3.8 years

First QC Date

May 10, 2010

Results QC Date

August 14, 2018

Last Update Submit

August 14, 2018

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Atrial FibrillationRobotic ControlRemote Control

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    91 - 365 days after the inital ablation procedure

Secondary Outcomes (2)

  • Acute Procedural Success

    Day 0

  • Chronic Safety-Incidence of Major Complications

    8 - 365 days post-procedure

Study Arms (1)

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.

Device: Ablation

Interventions

AblationDEVICE

Atrial fibrillation ablation procedure

Also known as: Sensei X Robotic Catheter System, Artisan Control Catheter, RF Ablation Catheters
Robotic catheter manipulation, Ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Banner Heart Hospital

Mesa, Arizona, 85206, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Saint Barnabas Heart Center

Livingston, New Jersey, 07039, United States

Location

Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Texas Health Arlington Memorial/Heart Place

Arlington, Texas, 76012, United States

Location

Texas Cardiac Arrhythmia Research Foundation (TCARF)

Austin, Texas, 78705, United States

Location

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

Univeristy of Virginia

Charlottesville, Virginia, 22908, United States

Location

IKEM, Dept of Cardiology

Prague, Czechia

Location

Gentofte University Hospital

Hellerup, 2900, Denmark

Location

Hospital Universitario Madrid Montepríncipe

Madrid, Spain

Location

John Radcliff Hospital

Oxford, OX39DU, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

Title
Emir Deljkich/Sr. Director, Clinical Affairs
Organization
Auris Health, Inc.
emir.deljkich@aurisrobotics.com
650-397-2677

Study Officials

  • Joseph Gallinghouse, M.D.

    Texas Cardiac Arrhythmia Research Foundation

    PRINCIPAL INVESTIGATOR

  • Andrea Natale, M.D.

    Texas Cardiac Arrhythmia Research Foundation

    PRINCIPAL INVESTIGATOR

  • Brenda Cayme, RN., BSN

    Hansen Medical, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2010

First Posted

May 13, 2010

Study Start

July 1, 2013

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

September 11, 2018

Results First Posted

September 11, 2018

Record last verified: 2018-08

Locations

CZ(1)DK(1)GB(1)ES(1)US(9)