IntellaTip MiFi XP Ablation Catheter Trial (MiFi-CTI)

Boston Scientific

Status: Completed

Conditions: Atrial Flutter

Treatments: Device: IntellaTip MiFi XP Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT01730807

MiFi-CTI

Details and patient eligibility

About

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

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

IntellaTip XP MiFi

Experimental group

Description:

Patients with Atrial Flutter will receive ablation treatment with the IntellaTip MiFi XP catheter

Treatment:

Device: IntellaTip MiFi XP Catheter