IntellaTip MiFi XP Ablation Catheter Trial

Boston Scientific Corporation10 enrolled

Overview

A study to assess the performance of a new catheter design for the treatment of Atrial Flutter.

A prospective, non-blinded, single arm, single center study designed to assess the performance of the IntellaTip MiFi XP Ablation Catheter for the treatment of recurrent or sustained type I atrial Flutter.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atrial Flutter

Interventions

IntellaTip MiFi XP CatheterDEVICE

Temperature controlled ablation catheter

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 or older * indicated for ablation for Atrial Flutter Exclusion Criteria: * Thrombus * Recent MI/cardiac revascularization * Prosthetic Valves * recent ablation for atrial flutter * atrial flutter with reversible cause * Class IV HF

Locations (1)

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Outcomes

Primary Outcomes

Acute Procedural Success

The Demonstration of bi-directional isthmus block at the end of the ablation procedure

Time frame: one day

Secondary Outcomes

Complication Rate at procedure

Determine major complications in patients exposed to the device, which occur within 7 days of the procedure

Time frame: 7 days

Data from ClinicalTrials.gov

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