Catheter Ablation of Atrial Fibrillation Using Hansen Medical Robotic Navigation

B

Barts & The London NHS Trust

Status and phase

Terminated
Phase 4

Conditions

Atrial Fibrillation

Treatments

Procedure: catheter ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT01037296
005815

Details and patient eligibility

About

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.

Enrollment

166 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

166 participants in 2 patient groups

manual ablation
Other group
Treatment:
Procedure: catheter ablation
robotic ablation
Experimental group
Treatment:
Procedure: catheter ablation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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