Personalized Atrial Fibrillation Ablation with QDOT Catheter
Personalized Atrial Fibrillation Ablation With the QDOT Catheter - The QDOT-by-LAW Trial
This study tests if a new catheter can help people with paroxysmal atrial fibrillation have better long-term results after heart ablation compared to standard methods.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 77 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro Medico Teknon Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT04298177 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the QDOT® catheter for performing high-power short-duration ablation in patients with paroxysmal atrial fibrillation (PAF). The study aims to assess the long-term outcomes of this novel approach compared to standard ablation techniques. Participants will undergo circumferential pulmonary vein isolation (PVI) to determine the catheter's safety and efficacy in preventing arrhythmia recurrence. The trial builds on previous findings that suggest improved outcomes with advanced catheter technology.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have been diagnosed with paroxysmal atrial fibrillation and are intolerant or refractory to medical treatment.
Not a fit: Patients under 18 years old, pregnant women, or those who have previously undergone atrial fibrillation procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and safer treatment options for patients suffering from atrial fibrillation.
How similar studies have performed: Previous studies have shown promising results with similar catheter technologies, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years. * Indication for paroxysmal atrial fibrillation ablation. * Signed informed consent Exclusion Criteria: * Age \< 18 years. * Pregnancy. * Previous AF redo procedure. * Impossibility to perform a pre-procedural CT scan. * Concomitant investigation treatments. * Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.
Where this trial is running
Barcelona
- Teknon Medical Center — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Antonio Berruezo, MD, PhD — Centro Medico Teknon
- Study coordinator: Antonio Berruezo, MD, PhD
- Email: antonio.berruezo@quironsalud.es
- Phone: (+34) 93 290 62 51
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.