atrial fibrillation
Conditions
Interventions
The following evaluations will be done as per the protocol requirements (not
standard of care)
Baseline Evaluations:
Determination of the NYHA functional class
Quality of life assessment
Pregnancy
Sponsors
St. Jude Medical GVA Sàrl
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient is planned to undergo a catheter ablation procedure due to symptomatic PAF that is refractory or intolerant to at least one Class I-IV antiarrhythmic drug 2. Minimum of one episode of PAF greater than 30 seconds in duration within 12 months prior to enrollment documented by 12 lead electrocardiogram (ECG), Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device 3. Minimum of 3 episodes of PAF within the preceding 12 months documented by patient history 4. Patient is 18 years of age or older 5. Patient is willing and capable of complying unassisted with the study protocol requirements including all specified follow up visits 6. Patient provides written informed consent prior to enrollment in the study
Exclusion criteria
Exclusion criteria: 1. Persistent or long-standing persistent atrial fibrillation (AF) 2. Patient has had 4 or more cardioversions in the last 12 months 3. Active systemic infection 4. Presence of implantable cardiac defibrillator (ICD) 5. Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, and other major surgical procedures in the preceding 3 months 6. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 3 months 7. Left atrial diameter > 5.0 cm 8. Left ventricular ejection fraction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness The primary effectiveness endpoint of the study is a non-inferiority comparison of treatment success between the TactiCath® Set and the control device as defined by both: • Acute procedural success - electrical isolation of all 4 pulmonary veins (PVs), or in the event of a common PV, the clinical equivalent of all PVs by the end of index procedure • Chronic success - acute procedural success and freedom from recurrence of symptomatic PAF, atrial flutter (AFL), and atrial tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3 month blanking period. Re-treatment for AF with ablation or the use of Class I or Class III antiarrhythmic drugs after the blanking period constitutes a treatment failure. Safety The primary safety endpoint is a non-inferiority comparison of device-related early onset primary SAEs between the TactiCath® Set and the control device occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness The secondary effectiveness endpoints are related to the use of the contact force sensor and will assess procedural effectiveness superiority of the TactiCath® Set over the control device. It is hypothesized that the use of the contact force sensor information will result in added procedural effectiveness through a reduction of: 1. Number of electrically reconnected pulmonary veins following a 30 minute waiting period assessed by entrance block 2. Time to achieve total PV isolation measured from initial application of RF energy to all target vessels isolated 3. Total time of RF application required for full PV isolation Safety Incidence of all serious adverse events (SAEs) during the 12 month follow up period | — |
Countries
Netherlands
Outcome results
None listed