Catheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation

Atrial Fibrillation Clinical Trial

— Hansen  

Official title:

Catheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation - A Randomised Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01037296
• Other study ID #: 005815
• Status: Terminated
• Phase: Phase 4
• First received: December 21, 2009
• Last updated: July 9, 2014
• Start date: April 2008
• Est. completion date: September 2013

Study information

• Verified date: March 2014
• Source: Barts & The London NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: London: Redbridge and Waltham Local Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Atrial fibrillation (AF) affects as many as 1 in 100 people and reduces the quality of life of large numbers of people in the UK and around the world. Catheter ablation is a minimally invasive treatment that has been developed to help eliminate AF. It is a complex procedure to perform so only a few hospitals are able to offer this treatment in the UK. A new technology allows the operator to guide their catheters (thin wires) in the patient by using a robotically steered sheath. This allows accurate and precise navigation that may improve the accuracy and integrity of ablation. We aim to prove whether this technology can make AF ablation easier and more effective.

Substudy: Platelet reactivity and activation in AF, and the impact of curative ablation. Blood and urine samples will be taken pre- and 3 months post ablation to see if platelet reactivity and activation are affected by AF compared to established normal ranges, and whether curative ablation impacts on this.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 166
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients with symptomatic AF planned for catheter ablation.

Exclusion Criteria:

• Age < 18 years

• Previous ablation procedure

• Expected life expectancy < 6 months

• Inability or unwillingness to sign consent

• Pregnancy

• Contraindications for the ablation procedure o Thrombus in the left atrium that fails to resolve with optimal oral anticoagulation therapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• catheter ablation
ablation procedure performed with Hansen robotic navigation system
• catheter ablation
Ablation will be performed as normal treatment

Locations

Country	Name	City	State
United Kingdom	Barts and the London NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Barts & The London NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Ullah W, McLean A, Hunter RJ, Baker V, Richmond L, Cantor EJ, Dhinoja MB, Sporton S, Earley MJ, Schilling RJ. Randomized trial comparing robotic to manual ablation for atrial fibrillation. Heart Rhythm. 2014 Nov;11(11):1862-9. doi: 10.1016/j.hrthm.2014.06 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single procedure success rate at 12 months		12 months	No
Secondary	Complication rates, catheter stability, procedure/fluoroscopy time (and dose), subjectively assessed operator fatigue		0-12 months	No
Secondary	Platelet substudy: Platelet activation post ablation compared to baseline.		3 months	No