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

Ablation at St. George Hospital - Prospective Randomized Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00982475

Enrollment

130

Registered

2009-09-23

Start date

2009-09-30

Completion date

2018-02-27

Last updated

2018-03-07

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

Conditions

Atrial Fibrillation

Keywords

pulmonary vein isolation, robotic navigation, atrial fibrillation

Brief summary

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.

Interventions

PROCEDUREPulmonary vein isolation with radiofrequency current

Pulmonary vein isolation with radiofrequency current

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Freedom of AF 12 months after procedure.	12 month

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026