A Clinical Trial for the Assessment of the Safety and Performance of the Vimecon Laser Cardiac Ablation Instrument (CAI) for the Interventional Treatment of Paroxysmal Atrial Fibrillation (AF)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Vimecon GmbH
- Enrollment
- 1
- Locations
- 3
- Primary Endpoint
- Safety assessment, free of any Major Adverse Events's or safety events within the first three (3) months after the treatment..
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
This study is a prospective, non-randomized, single arm, multicenter, CE marking trial for patients with paroxysmal atrial fibrillation to undergo an ablation of the cardiac tissue near the PV.
Detailed Description
The objective of this clinical investigation is to confirm the safety and performance of the Vimecon® Laser Cardiac Ablation Instrument when creating scar tissue within the cardiac wall for the treatment of atrial fibrillation. Up to 66 patients with paroxysmal atrial fibrillation refractory to at least one antiarrhythmic medications (Class I or III) are enrolled. with an expected 10% dropout; 59 per protocol patients are required. The study duration will be 18 month with a 6 month enrollment period and 12 month follow-up. Interim follow-up visits are at post procedure, 1 Month, 3 Months, 6 Months and 12 Months. The baseline and follow up tests are standard of care. Additional optional tests are an esophageal endoscopy for determination of potential fistula formation and a cerebral MRI for micro embolism post treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 18 to 75 years.
- •Patients with intention to be treated for paroxysmal atrial fibrillation. AND unresponsive to ≥1 antiarrhythmic drug (class I or III) AND at least 2 episodes in the last 12 months, 1 of them documented.
- •Patient should be on an anticoagulation therapy according to the international guidelines (per ACC/AHA//ESC Practice Guidelines)
- •Left atrial (LA) size \< 50 mm
- •Symptomatic AF (EHRA-Score ≥ 2)
- •Accessibility of femoral vein and pulmonary veins
- •All patients willing to comply with the study protocol for at least 12 months
Exclusion Criteria
- •Inability to give written informed consent
- •NYHA Class III and IV
- •Hyperthyroidism
- •Reversible causes of the AF like Pericarditis, Electrolytic imbalance
- •Left Atrial Thrombus formation
- •Structural heart disease disturbing accessibility for AF ablation.
- •Valvular AF, permanent and long-standing persistent AF, currently present Atrial Flutter
- •Any valvular dysfunction more than II°
- •Systemic infections or endocarditis.
- •Impaired left ventricular function with an ejection fraction of less than 35%
Outcomes
Primary Outcomes
Safety assessment, free of any Major Adverse Events's or safety events within the first three (3) months after the treatment..
Time Frame: < month-3
Safety: • Evaluating the proportion of subjects free from experiencing Serious Adverse Events related to the catheter ablation procedure (Major Adverse Events's or safety events) within the first three (3) months after the treatment. Major adverse events (MAE, Safety events) associated with the catheter ablation procedure include: * Cardiac tamponade * Thromboembolic events including pulmonary embolism and stroke * Complete heart block * Acute myocardial infarction * Phrenic nerve palsy * Atrio-esophageal fistula * Vascular complications * Death