Identifying and treating heart rhythm issues in patients with specific heart conditions
Arrhythmogenic Substrate Assessment in Patients With Primary Cardiomyopathies and/or Channellopaties With and Without History of Brugada Syndrome: A Prospective Follow-up Study
This study is testing if a procedure called catheter ablation can help people with certain heart conditions and implanted devices by fixing heart rhythm problems to prevent serious issues like sudden cardiac death.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, Milano) |
| Trial ID | NCT03304847 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of catheter ablation in identifying and eliminating arrhythmogenic substrates to prevent recurrent ventricular arrhythmias and sudden cardiac death in patients with primary cardiomyopathy and/or channelopathies who have an implanted ICD. It is a prospective single-center study conducted at the Arrhythmology Department of San Donato Milanese Hospital. Eligible patients will undergo endo-epicardial electroanatomical 3D mapping and radio-frequency ablation, followed by a structured follow-up schedule to monitor their condition and response to treatment.
Who should consider this trial
Good fit: Ideal candidates include adults with specific types of cardiomyopathy or channelopathies who have an implanted ICD and experience symptoms related to ventricular arrhythmias.
Not a fit: Patients who are pregnant, breastfeeding, or have a life expectancy of less than 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of life-threatening arrhythmias and improve survival rates in affected patients.
How similar studies have performed: Other studies have shown promise in using catheter ablation for similar arrhythmogenic conditions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients affected by cardiomyopathies and/or channellopaties (long QT syndrome and J-wave syndrome) with and without documented family history of BrS; * Presence of symptoms attributable to VA and/or presenting documented arrhythmic episodes; * Patients with an ICD already implanted; * Patients referred to the centre for an electrophysiological study and indication for a potential concomitant radio-frequency catheter ablation (RFA) of ventricular tachycardia (VT) or ventricular fibrillation (VF); * Age ≥ 18; * Willingness to attend follow-up examinations; * Written informed consent for the participation in the trial Exclusion Criteria: * Pregnancy or breast-feeding; * Life expectancy \< 12 months
Where this trial is running
San Donato Milanese, Milano
- IRCCS Policlinico S. Donato — San Donato Milanese, Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Carlo Pappone, MD — Chief of Arrhythmology Department
- Study coordinator: Carlo Pappone, MD
- Email: carlo.pappone@af-ablation.org
- Phone: +39 02 52774260
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.