Catheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01037296

Acronym

Hansen

Enrollment

166

Registered

2009-12-23

Start date

2008-04-30

Completion date

2013-09-30

Last updated

2014-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

catheter ablation, robotic navigation

Brief 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.

Interventions

PROCEDUREcatheter ablation

ablation procedure performed with Hansen robotic navigation system

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Single procedure success rate at 12 months	12 months

Secondary

Measure	Time frame
Complication rates, catheter stability, procedure/fluoroscopy time (and dose), subjectively assessed operator fatigue	0-12 months
Platelet substudy: Platelet activation post ablation compared to baseline.	3 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026