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

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000317796

Acronym

MiFi CTI

Enrollment

Registered

2013-03-21

Start date

2013-03-04

Completion date

2013-05-22

Last updated

2020-01-13

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

Conditions

None listed

Brief 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.

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 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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* At least one (1) documented episode of type I atrial flutter preceding enrollment documented by 12-lead ECG, Holter monitor, rhythm strip, or trans telephonic monitor * Subjects are clinically indicated for standard of care catheter ablation for type I atrial flutter * Age 18 or above, or of legal age to give informed consent specific to state and national law * Subjects or their legal representative are competent and willing to provide written informed consent to participate in the study and agree to (and are able to) comply with follow-up visits and evaluation

Exclusion criteria

* Any cardiac ablation within 90 days prior to enrollment * Previous CTI ablation * Cardiac surgery within 90 days prior to enrollment * Myocardial infarction (MI) or cardiac revascularization (percutaneous coronary intervention) within 60 days prior to enrollment * Current unstable angina * Documented atrial or ventricular tumors, clots, thrombus, Deep Vein Thrombus (DVT)or have a known clotting disorder within 90 days prior to enrollment * Implantation of permanent leads of an implantable device in or through the right atrium within 30 days prior to enrollment.

Outcome results