Atrial Fibrillation
Conditions
Keywords
atrial fibrillation
Brief summary
This is a prospective, non-randomized, multicenter, multi-country pilot study to evaluate the safety and effectiveness of the Ablation Frontiers Cardiac Ablation System for the ablative treatment of symptomatic permanent atrial fibrillation.
Detailed description
The study shall be conducted according to ISO 14155. Results of this research study will be used to assess the performance and safety of the System and its components. Data may be combined with similar research at additional sites to create a greater understanding of the endpoints. Up to sixty (60) patients (including roll-in or training patients) will be enrolled in a non-randomized study to assess the safety and efficacy of the Ablation Frontiers Cardiac Ablation System. Further studies may be performed to gather additional data regarding the safety and efficacy of the system. Patients with a history of symptomatic permanent AF, willing and able to sign an informed consent, and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study. Comparative and descriptive statistics will be used to summarize patient outcomes for the specified study endpoints.
Interventions
PROCEDUREAblation procedure and/or cardioversion
Ablation Frontiers Cardiac Ablation System
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* History of symptomatic permanent atrial fibrillation * Age between 18 and 70 * Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study
Exclusion criteria
* Structural heart disease of clinical significance * Any prior ablation for atrial fibrillation * Prior ablation for arrhythmias other than AF within the past three months * Enrollment in any other ongoing arrhythmia study protocol * Any ventricular tachyarrhythmias currently being treated where the arrhythmia or the management may interfere with this study * Active infection or sepsis * Any history of cerebral vascular disease including stroke or TIAs * Pregnancy or lactation * Left atrial thrombus at the time of ablation * Untreatable allergy to contrast media * Any diagnosis of AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes * History of blood clotting (bleeding or thrombotic) abnormalities * Known sensitivities to heparin or warfarin * Severe COPD (identified by an FEV1 \< 1) * Severe comorbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The acute/chronic safety endpoint is recording of all Severe Adverse Events (device and procedure related) followed for six months. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness | 6 months |
Countries
Netherlands, Switzerland, United Kingdom
Outcome results
None listed