Gen2 Isthmus-Dependent Atrial Flutter Ablation Study

Gen2 Cardiac Ablation System Isthmus-Dependent Atrial Flutter Study

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00606463

Enrollment

Registered

2008-02-04

Start date

2008-02-29

Completion date

2009-01-31

Last updated

2023-07-14

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

Conditions

Atrial Flutter

Brief summary

Irrigated catheter for ablation of isthmus-dependent atrial flutter

Detailed description

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

Interventions

DEVICECardiac Ablation (Gen2 Cardiac Ablation System)

Ablation of isthmus-dependent atrial flutter

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of intraprocedural, serious cardiac adverse event	7 days post-procedure	Defined as the Incidence of intraprocedural, serious cardiac adverse event

Other

Measure	Time frame	Description
Bi-direction block and non-inducibility of atrial flutter	Procedural	Acute Procedure success defined as bi-directional block and non-inducibility of atrial flutter

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026