Assessment of Procedural Times of Laser Ballon Ablation, Assessment of Safety of Laser Balloon Ablation
Conditions
Keywords
laser ballon ablation, laser ballon, pulmonary vein isolation, atrial fibrillation, AF ablation
Brief summary
To assess the efficacy of laser balloon ablation of atrial fibrillation (AF) without verification of electrical isolation of pulmonary veins using implantable loop recorder. This is a prospective and single-center study. A targeted number of 82 patients suffering from paroxysmal or persistent AF, indicated to undergo catheter ablation will be included. The study will consist of: i) patient enrolment, ii) treatment phase, and iii) 1-year follow-up phase. The duration of the study is expected to be 24 months, from first patient enrolment to last patient follow up.
Detailed description
This is a prospective and single-center study. A targeted number of 82 patients suffering from paroxysmal or persistent AF, indicated to undergo catheter ablation will be included. The study will consist of: i) patient enrolment, ii) treatment phase, and iii) 1-year follow-up phase. The duration of the study is expected to be 24 months, from first patient enrolment to last patient follow up. In a recent meta-analysis including 1188 patients, free from arrhythmic recurrences at 12 months after a single ablative procedure with a laser balloon and without continuous monitoring with ILR was 74%1. Assuming that the approach without post-ablative verification of pulmonary vein isolation and continuous monitoring with ILR can lead to a 60% success rate at 12 months, 80 patients are required to have an 80% probability to observe a level of 2-code significance of 0.05 in an exponential model with the log rank test. With an estimated loss of data (patients lost to follow-up, protocol deviations and incomplete data) of 5%, the total number of patients to be enrolled is 82. Subject screening and enrolment will be carried out for approximately 12 months. The study will continue up to 12 months after last patient enrolment, dependent on the rate of enrolment and the regulatory timeline (as applicable).
Interventions
OTHERLaser ballon ablation for Pulmonary vein isolation
The patients indicated to AF ablation procedure will be treated with laser balloon ablation without verification of electrical isolation of pulmonary veins using implantable loop recorder and/or Holter monitoring
Sponsors
IRCCS Policlinico S. Donato
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Inclusion criteria
To participate in this clinical subject, the subject must meet all of the following inclusion criteria: * Age between 18 and 85 years * Paroxysmal or persistent AF * Patients AF who have indications for the first time ablation procedure according to the ESC / EHRA recommendations (European Society of Cardiology / European Heart Rhythm Association). * Ability to provide written informed consent for study participation and be willing and able to comply with the study evaluations and follow up schedule
Exclusion criteria
Subjects are not eligible for clinical study participation if they meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate at 1 year | 12 months after ablation | Free from AF, atrial tachycardia and flutter documented with ILR or Holter ECG monitorwithout antiarrhythmic drugs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural and 1-year complications related to the ablation procedure. | during the procedure and 12 months after ablation | Procedural and 1-year complications related to the ablation procedure. |
| inducibility of AF after the procedures | During the procedure | programmed atrial stimulation before and after isoproterenol |
| AF Burden | 12 months after ablation | Assessment of AF burden by holter monitoring or implantable loop recorder |
Countries
Italy
Outcome results
None listed