An interventional study of Radiofrequency balloon catheter ablation in Atrial Fibrillation, sponsored by Jim Hansen. Active, not recruiting at 1 site in Denmark. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by Jim Hansen · Not applicable, Interventional, and Treatment
Atrial fibrillation (AF) is the most common heart rhythm disorder affecting 2-4% of the adult human population. AF is a disturbance in the electrical impulses of the heart - an electrical disturbance commonly originating from the pulmonary veins.
Normalization of the heart rhythm with anti-arrhythmic drugs often fail and is frequently associated with side effects. Therefore, a treatment termed ablation by catheters via an inguinal vein has been devised and is increasingly being used for the treatment of AF. The cornerstone of this treatment is electrical isolation of the pulmonary veins so that the nocuous electrical impulses from the pulmonary veins cannot cause a disturbance in the heart rhythm and initiate episodes of AF. This treatment is called pulmonary vein isolation (PVI). Recent studies have shown that PVI is better than anti-arrhythmic drug treatment in the prevention of recurrence of AF, but despite substantial improvements in techniques and tools only 60-70% are cured from AF by a single PVI procedure, and in around 80% of patients who require additional catheter ablation, durable isolation of all the pulmonary veins has not been achieved. Improved tools for durable PVI are therefore required.
A novel catheter to achieve PVI called the HELIOSTAR™ radiofrequency balloon ablation catheter has shown promising clinical results with a favorable safety profile, but the durability of PVI has not been evaluated. Therefore, we aim to investigate the long-term durability of PVI by the radiofrequency balloon and the clinical outcome following the procedure.
In this study, patients with AF referred for catheter ablation will undergo an initial PVI treatment using the radiofrequency balloon catheter. All patients will undergo a repeat electrophysiology (EP) study after 4-6 months to determine to durability of PVI. Patients will be issued with a 48-hour heart rhythm monitor at 3 and 12 months after the initial PVI. Patients-reported effects on quality of life by AF related symptoms will be evaluated using a specialized questionnaire provided approximately every third month throughout the 12 month follow-up.
The study is a single-arm prospective cohort study in 45 patients referred for AF ablation that will assess the durability of PVI, freedom from atrial tachyarrhythmia (ATA) recurrence and patient reported quality of life following PVI by radiofrequency balloon catheter ablation.
All patients, irrespective of ATA recurrence, will undergo a repeat EP study 4-6 months after initial PVI for the assessment of PVI durability. Recurrence of ATA after the initial PVI will be evaluated by 48-hour ambulatory electrocardiography (ECG) monitoring following a 3-months blanking period after the PVI procedure, and effect on quality of life will be evaluated by questionnaires at baseline, 3 months after the initial PVI, and at the time of the repeat procedure.
Recurrence of ATA after the repeat EP study will be evaluated by 48-hour ambulatory ECG monitoring 12 months after the initial PVI, and effect on quality of life will be evaluated by additional questionnaires at 9 and 12 months after the initial PVI.
In patients with symptoms of potentiel ATA outside the protocolled ambulatory ECG monitoring periods, ECG diagnostics appropriate for the duration and frequency of episodes with symptoms will be utilized.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 45 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →This is the only study on the registry with Jim Hansen as lead sponsor.
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Exclusion Criteria:
Enrolled patients will undergo PVI by radiofrequency balloon ablation.
Procedure: Radiofrequency balloon catheter ablation
Radiofrequency balloon ablation using the HELIOSTAR™ ablation catheter.
Proportion of durably isolated PVs observed at repeat EP study
During repeat EP study 4-6 months after initial PVI, all PVs are assessed for bidirectional block. Any reconnected PVs will be reisolated. After confirmation of bidirectional conduction block (preceded by reisolation in case of PV reconduction), adenosine injections will be used to test for dormant conduction. PVs with dormant conduction are not considered durably isolated.
Time frame: 4-6 months
Proportion of patients with durable isolation of all PVs observed at repeat EP study
During repeat EP study 4-6 months after initial PVI, all PVs are assessed for bidirectional block. Any reconnected PVs will be reisolated. After confirmation of bidirectional conduction block (preceded by reisolation in case of PV reconduction), adenosine injections will be used to test for dormant conduction. PVs with dormant conduction are not considered durably isolated.
Time frame: 4-6 months
Proportion of patients remaining free from recurrence of ATA after the initial PVI
The proportion of patients that remain free from recurrence ATA (AF, atrial flutter, and/or atrial tachycardia) ≥ 30 seconds of duration following a 3 month blanking period after initial PVI, documented by any type of ECG.
Time frame: 4-6 months
Difference in the effect of AF related symptoms on quality of life between baseline and after the initial PVI
The effect of AF related symptoms on quality of life assessed by the sum of units on The Atrial Fibrillation Effect on QualiTy of life survey (AFEQT) questionnaire
Time frame: 4-6 months
Complications
Complications attributed to radiofrequency balloon catheter ablation
Time frame: Occurring within 3 months after the initial PVI procedure
Proportion of patients remaining free from recurrence of ATA after the repeat EP study
The proportion of patients that remain free from recurrence ATA ≥ 30 seconds of duration following a 3 month blanking period after the repeat EP study, documented by any type of ECG.
Time frame: 12 months
Difference in the effect of AF related symptoms on quality of life between baseline, after the initial PVI, and after the repeat EP study
The effect of AF related symptoms on quality of life assessed by the sum of units on AFEQT questionnaire
Time frame: 12 months
Plan to share: No
This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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