Atrial Fibrillation – TactiFlex PAF IDE

Speciality

Cardiology

Description

To evaluate the safety and effectiveness of a new ablation catheter used in patients to treat drug refractory, symptomatic, paroxysmal atrial fibrillation.

Eligibility criteria

To be considered for the study you must meet the following criteria:

  • 18 years of age or older
  • Be planned for a catheter ablation procedure due to symptomatic paroxysmal atrial fibrillation that is refractory or intolerant to at least one class I or III antiarrhythmic drug
  • Noted by a physician to have had recurrent self-terminating atrial fibrillation
  • Had at least one ECG in the last 12 months which documented an episode of atrial fibrillation
Study details

Your participation in this study would be for approximately 12 months.

You will need to attend the clinic for an initial assessment, including medical history and physical examination, ECG, echocardiogram if not performed within the last 6 months and complete questionnaires regarding physical symptoms and quality of life. You will also be required to undertake a neurological assessment at the beginning of the study and during your hospital admission.

Eligible participants will then need to go to hospital to have their clinically indicated catheter ablation procedure. Follow-up assessments will occur before hospital discharge and then at 7 days (phone call), 5 weeks (phone call), 3 months (in-person visit), 6 months (phone call) and 12 months (in-person visit) where you will again be asked about your health and medications, have ECG’s and be asked to complete questionnaires about your quality of life. You will also be provided with a device for trans-telephonic monitoring (TTM) of your heart’s rhythm. You will attach this device to your bare chest and follow the provided instructions to send a transmission of your heart’s rhythm once every 14-days until the 12-month study visit.

There are no additional costs associated with participating, nor will you be paid. All medication, tests and medical care required as part of the study will be provided to you free of charge.

Further information

NCT0435640

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