Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Atrial Flutter

Clinical Study to Evaluate the Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Cavo-Tricuspid Valve Isthmus-Dependent Atrial Flutter

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00113178

Enrollment

160

Registered

2005-06-07

Start date

2004-01-31

Completion date

2005-06-30

Last updated

2011-02-24

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

Conditions

Atrial Flutter

Keywords

atrial flutter, cryoablation

Brief summary

The purpose of this study is to evaluate the safety and efficacy of right atrial intra-cardiac lesions created by transvenous catheter cryoablation in patients with atrial flutter.

Detailed description

Catheter ablation of arrhythmias has become an accepted alternative to pharmacologic therapy. Cryoablation is a newer alternative to radiofrequency ablations. This study expands the prior pilot experience with the CryoCor™ Cardiac Cryoablation System to a larger cohort of patients with atrial flutter.

Interventions

DEVICECatheter-based cardiac cryoablation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Symptomatic atrial flutter

Exclusion criteria

* Prior ablation * Contraindication to intervention * Poor general health

Design outcomes

Primary

Measure	Time frame
Acute efficacy	—
Acute safety	—

Secondary

Measure	Time frame
Long-term efficacy	—
Long-term safety	—

Outcome results

None listed

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