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

Boston Scientific Corporation160 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Atrial Flutter

Interventions

Catheter-based cardiac cryoablationDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Symptomatic atrial flutter Exclusion Criteria: * Prior ablation * Contraindication to intervention * Poor general health

Outcomes

Primary Outcomes

Acute efficacy

Acute safety

Secondary Outcomes

Long-term efficacy

Long-term safety

Data from ClinicalTrials.gov

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