NCT05805189Active, not recruiting
Prospective Evaluation of Biophysical Parameters as Long-term Predictors of Pulmonary Vein Isolation
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)
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
Current, worldwide assessments of the prevalence of AF estimate that 33 million people are affected by this cardiac arrhythmia. As the most common sustained atrial arrhythmia, AF has a well-established association with systemic embolic events, stroke, heart failure, and increased mortality. Current treatment guidelines and consensus statements for patients with AF suggest that most patients should be first managed with a pharmaceutical drug therapy; however, when a patient becomes drug refractory (intolerant or non-responsive), catheter ablation by PV isolation (PVI) is recommended. The aim of PVI is abolishment of all conducted electrical activity beyond the isolating lesions. The recent NICE guidelines have established that today RF point-by-point ablation is the most cost-effective treatment approach over a lifetime after failure of 1 or more anti-arrhythmic drugs5, but until now a new technology, HELIOSTAR, RF Balloon, has not been included in this cost-effectiveness analysis
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 28 Mar 2023
- Start date
- 9 Feb 2023
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Maria Cecilia Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT05805189
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 9 Feb 2023 to the primary completion date, 30 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Hematological contraindications to ionizing radiation exposure
Other illness
- 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)
Lab values
- Patients with left ventricular ejection fraction \< 35%
Other
- 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
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon investigator's discretion)
- Contraindications to general anesthesia
- Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maria Cecilia Hospital Coordinator of this site? Confirm its status | Cotignola | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.