Gen2 Isthmus-Dependent Atrial Flutter Ablation Study

Abbott

Status: Terminated

Conditions: Atrial Flutter

Treatments: Device: Cardiac Ablation (Gen2 Cardiac Ablation System)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00606463

0611.1

Details and patient eligibility

About

Irrigated catheter for ablation of isthmus-dependent atrial flutter

Full description

This study intends to use an investigational irrigated catheter for ablation of isthmus-dependent atrial flutter

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled for ablation of isthmus-dependent atrial flutter

Exclusion criteria

• Prior ablation of isthmus-dependent atrial flutter
• Atypical or scar flutter
• Significant heart disease
• Intracardiac thrombus
• Prior cardiac surgery (within 1 month)
• Contraindication to heparin

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

(Gen2 Cardiac Ablation System)

Experimental group

Description:

Ablation of isthmus-dependent atrial flutter

Treatment:

Device: Cardiac Ablation (Gen2 Cardiac Ablation System)