Alster Man and Machine: Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation

Dr. Kai Jaquet

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: Pulmonary vein isolation with radiofrequency current

Study type: Interventional

Funder types: Industry

Identifiers

NCT00982475

1889

Details and patient eligibility

About

Long term results after pulmonary vein isolation (PVI) with robotic navigation in patients with drug refractory atrial fibrillation are not inferior to manual radiofrequency current ablation.

Enrollment: 130 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• paroxysmal atrial fibrillation
• persistent atrial fibrillation < 2 month
• indication for catheter ablation
• LEF > 50%
• diameter LA < 50 mm

Exclusion criteria

• intracardial thrombus
• atrial fibrillation with underlying curable disease
• renal failure > stage I
• contraindication for anticoagulation
• life expectancy < 12 month
• previous PVI
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups, including a placebo group

PVI with robotic navigation

Active Comparator group

Treatment:

Procedure: Pulmonary vein isolation with radiofrequency current

PVI manually

Placebo Comparator group

Treatment:

Procedure: Pulmonary vein isolation with radiofrequency current