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

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

A Prospective, Single Arm Study of the Hansen System for Introducing and Positioning RF Ablation Catheters in Subjects With Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01122173
• Other study ID #: HMP010
• Status: Terminated
• Phase: N/A
• Start date: July 2013
• Est. completion date: April 2017

Study information

• Verified date: August 2018
• Source: Hansen Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• Ablation
Atrial fibrillation ablation procedure

Locations

Country	Name	City	State
Czechia	IKEM, Dept of Cardiology	Prague
Denmark	Gentofte University Hospital	Hellerup
Spain	Hospital Universitario Madrid Montepríncipe	Madrid
United Kingdom	John Radcliff Hospital	Oxford
United States	Texas Health Arlington Memorial/Heart Place	Arlington	Texas
United States	Texas Cardiac Arrhythmia Research Foundation (TCARF)	Austin	Texas
United States	Univeristy of Virginia	Charlottesville	Virginia
United States	Englewood Hospital and Medical Center	Englewood	New Jersey
United States	Greenville Memorial Hospital	Greenville	South Carolina
United States	Houston Methodist Research Institute	Houston	Texas
United States	Saint Barnabas Heart Center	Livingston	New Jersey
United States	Banner Heart Hospital	Mesa	Arizona
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Hansen Medical

Countries where clinical trial is conducted

United States,  Czechia,  Denmark,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	within 7 days of the ablation procedure nd the incidence of esophageal injury or pulmonary vein stenosis through 180 days
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.	91 - 365 days after the inital ablation procedure
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.	Day 0
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.	8 - 365 days post-procedure