Atrial fibrillation
Conditions
Interventions
The intervention is cardiac catheterization using an ablation catheter that is
slightly different from the catheter that is presently used in this patient
population.
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Be between eighteen and eighty years of age; Be scheduled for an atrial fibrilation ablation procedure; Be able to undergo contrast-enhanced MRI imaging; Have a cardiac CT or MRI scan within a 6 months time window prior to the planned procedure ; Be willing and able to sign the study specific consent form; Be willing and able to fulfill study requirements (including study follow-up visits); Have a negative pregnancy test for females in case of doubt about a possible pregnancy and Have documented paroxysmal or persistent atrial fibrillation (by electrocardiogram (ECG); trans-telephonic monitor (TTM); Holter monitor or telemetry strip)
Exclusion criteria
Exclusion criteria: Have evidence of or is currently receiving treatment for infection (local or systemic); Have evidence of LA thrombus prior to procedure; Be hypercoaguable (unable to tolerate heparin anticoagulation therapy) during the procedure; Have history of embolic event(s). (e.g., cerebrovascular accident, pulmonary embolism, transient ischemic attack, etc.); Have experienced a myocardial infarction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute Effectiveness (Technical Success) defined as: • Achievement of pulmonary vein ostia isolation confirmed at least 30 minutes following the last RF ablation for pulmonary vein isolation with the Gen2 catheter Chronic Effectiveness (Clinical Success) defined as: • Freedom from paroxysmal or persistent atrial fibrillation at 6 months post-ablation in the absence of antiarrhythmic medication (Subjects maintained on a prevously ineffective dose of class I or class III antiarrhythmic medication will be evaluated for freedom from AF at 6 months post-ablation off antiarrhythmic medication) • Freedom from SAE (Safety Success) defined as: Use of the Gen2 Irrigated Ablation Catheter does not result in unacceptable risk defined by specific serious adverse events identified in the clinical literature review listed . If any Unanticipated Adverse Device Effects (UADEs) or 3 SAE*s from the CLINICAL LITERATURE IDENTIFIED SERIOUS ADVERSE EVENT LIST are recorded, the study will be halted and deemed a failure. | — |
Secondary
| Measure | Time frame |
|---|---|
| None | — |
Countries
Netherlands
Outcome results
None listed