Evaluating Biophysical Parameters for Predicting Pulmonary Vein Isolation Outcomes
Prospective Evaluation of Biophysical Parameters as Long-term Predictors of PVI With Multi-Electrode Radiofrequency Catheter: Comparison Between CARTO Guided and Fluoroscopy Guided Approach (MERCY Study)
NA · Maria Cecilia Hospital · NCT05805189
This study is testing a new balloon catheter treatment for patients with paroxysmal atrial fibrillation to see if it can improve their chances of successful heart procedure outcomes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maria Cecilia Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Cotignola, Ravenna) |
| Trial ID | NCT05805189 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of a multi-electrode RF Balloon catheter (HELIOSTAR) in performing pulmonary vein isolation (PVI) for patients with paroxysmal atrial fibrillation (AF). The study will evaluate various biophysical parameters as long-term predictors of successful PVI outcomes. Participants will undergo RF ablation using the HELIOSTAR system, which allows for tailored energy delivery and improved tissue contact. The trial will include patients who have not responded to drug therapy and are eligible for ablation according to current guidelines.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with paroxysmal atrial fibrillation who have not previously undergone an AF ablation procedure.
Not a fit: Patients who have already had an AF ablation or have contraindications to the procedure will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for patients with atrial fibrillation who require catheter ablation.
How similar studies have performed: Previous studies, such as RADIANCE and SHINE, have shown promising results with similar approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: The following criteria must be met for subjects to be eligible for inclusion into the study * Subjects indicated for the treatment of paroxysmal AF with the RF ablation system according to current and future Guidelines and system indications for use * Subjects who are willing and capable of providing informed consent * Patients who have stopped amiodarone for at least one month * Subjects whose age is \> 18 years old * Subjects whose age is \< 80 years old * Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center Exclusion Criteria: Subjects who meet any one of the following criteria will be excluded from this clinical study * Patients who had already undergo an AF ablation procedure * Any known contraindication to an AF ablation or anticoagulation, including those listed in the instructions for use * Subjects with indication for treatment of AF that is not according to current and future Guidelines and system indications for use * Presence of an intracavitary thrombus * Subjects that are unable or not willing to complete follow-up visits and examination for the duration of the study * Patients with left ventricular ejection fraction \< 35% * Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon investigator's discretion) * Hematological contraindications to ionizing radiation exposure * Presence of complex congenital heart disease, and cardiac surgery within 1 month from enrollment * Uncontrolled heart failure * Subjects with severe valvular disease OR with a prosthetic - mechanical or biological- heart valve (not including valve repair and annular rings) * Contraindications to general anesthesia * Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study
Where this trial is running
Cotignola, Ravenna
- Maria Cecilia Hospital — Cotignola, Ravenna, Italy (RECRUITING)
Study contacts
- Principal investigator: Saverio Iacopino, MD — Maria Cecilia Hospital
- Study coordinator: Saverio Iacopino, MD
- Email: siacopino@gvmnet.it
- Phone: 0545/217228
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation