RecruitingEarly Phase 1ACTRN12613000317796

Feasibility Study to assess the performance of IntellaTip MiFi™ XP Temperature Ablation Catheter System for the treatment of Subjects with Sustained or Recurrent Type I Atrial Flutter

Sponsor

Boston Scientific Corporation

Enrollment

20 participants

Start Date

Mar 4, 2013

Study Type

Interventional

Conditions

Atrial Flutter Arrhythmia

Summary

The ablation procedure uses tools called catheters to treat the atrial flutter. Ablation catheters are thin, flexible plastic tubes that use electrical energy to stop abnormal heart rhythms by heating (ablating) and destroying a small area of tissue to break the abnormal pathway. The purpose of this study is to evaluate the safety, performance and effectiveness (success) of a new ablation catheter that is used to treat atrial flutter. The new catheter is called the Intellitip MiFi XP Ablation Catheter. The catheter is made by the company Boston Scientific Corporation, who is also the sponsor of this research study.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Atrial flutter is an abnormal heart rhythm where the heart beats too fast and irregularly. Catheter ablation is a common procedure that uses a thin tube (catheter) inserted into the heart to deliver energy that destroys the small patch of tissue causing the abnormal rhythm. This study is testing a new type of ablation catheter — the IntellaTip MiFi XP — to see whether it is safe and effective in treating type I atrial flutter. You may be eligible if: - You are 18 years of age or older - You have had at least one documented episode of type I atrial flutter (confirmed by heart rhythm recording) - Your doctor has recommended catheter ablation as your treatment You may NOT be eligible if: - You have had a cardiac ablation procedure in the past 90 days - You have previously had a CTI (cavotricuspid isthmus) ablation - You have had heart surgery in the last 90 days - You have had a heart attack or coronary procedure in the last 60 days - You have an unstable heart condition, blood clots, or tumours in the heart - You have had a pacemaker lead implanted through the right atrium in the past 30 days Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Cardiac Radiofrequency Ablation A radiofrequency ablation catheter, IntelliTip MiFi™ XP, will be used to deliver energy to the cardiac tissue to create a line of scar (through heat) to the cavotric

Cardiac Radiofrequency Ablation A radiofrequency ablation catheter, IntelliTip MiFi™ XP, will be used to deliver energy to the cardiac tissue to create a line of scar (through heat) to the cavotricuspid isthmus in patients with Type I atrial flutter. The total procedure duration may last 1-5 hours, but typically does not take longer than 2 hours. A participant in the trial will undergo the procedure 1 time and will be seen at one week following the procedure to evaluate the participant.

Locations(1)

The Royal Adelaide Hospital - Adelaide

SA, Australia

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ACTRN12613000317796