Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Bern | OTHER |
Not provided
Not provided
Not provided
Not provided
Pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). Currently, Medtronic Arctic Front Cryoballoon is the most frequently used single shot technology and hence is the benchmark for upcoming technologies. A novel method, pulse-field ablation (PFA) using the FARAPULSE catheter, has recently been introduced (FARAPULSE PFA, Boston Scientific). However, whether FARAPULSE PFA provides effectiveness similar to the standard-of-practice Medtronic Arctic Front Cryoballoon is yet to be investigated. Given that FARAPULSE PFA has shown in studies not to cause any of the severe complications reported in association with traditional PVI while being highly effective, it might be even safer and more effective for use in AF ablation procedures.
The aim of this trial is to compare the efficacy and safety of PVI using FARAPULSE PFA (Boston Scientific) and the Arctic Front Cryoballoon (Medtronic) in patients with symptomatic paroxysmal AF undergoing their first PVI.
This is an investigator-initiated, multicenter, randomized controlled, open-label trial with blinded endpoint adjudication. Given that the Medtronic Arctic Front Cryoballoon is the standard-of-practice for PVI and the FARAPULSE PFA is the novel technology, this trial has a non-inferiority design.
The null hypothesis with regards to the primary efficacy endpoint is that the FARAPULSE PFA (Boston Scientific) shows lower efficacy compared to the Arctic Front Cryoballoon (Medtronic) and that therefore more episodes of first recurrence of any atrial arrhythmia between days 91 and 365 will be observed in patients with symptomatic paroxysmal AF undergoing their first PVI. Hence, the alternative hypothesis postulates that the FARAPULSE PFA is non-inferior to the Arctic Front Cryoballoon. Rejection of the null hypothesis is needed to conclude non-inferiority.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arctic Front Cryoballoon (Medtronic) | Active Comparator | Pulmonary vein isolation using the Arctic Front Cryoballoon (Medtronic) |
|
| Pulsed Field Ablation (FARAPULSE) | Active Comparator | Pulmonary vein isolation using the FARAPULSE PFA system (Boston Scientific) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVI using the Arctic Front Cryoballoon (Medtronic) | Device | Patients randomized to the Arctic Front cryoballoon group will undergo PVI using the Arctic Front Cryoballoon (Medtronic). At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first recurrence of any atrial tachyarrhythmia | Time to first recurrence of any atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between days 91 and 365 post ablation as detected on continuous implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 s or longer on ICM (the minimum programmable episode interval). | Days 91 to 365 post-ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with complications | Composite safety endpoint composed of:
| Days 0 to 30 post-ablation |
| Total procedure time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tobias Reichlin, MD | Inselspital, Bern University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | 4031 | Switzerland | |||
| Inselspital, Bern University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31085321 | Background | Reddy VY, Neuzil P, Koruth JS, Petru J, Funosako M, Cochet H, Sediva L, Chovanec M, Dukkipati SR, Jais P. Pulsed Field Ablation for Pulmonary Vein Isolation in Atrial Fibrillation. J Am Coll Cardiol. 2019 Jul 23;74(3):315-326. doi: 10.1016/j.jacc.2019.04.021. Epub 2019 May 11. | |
| 40162734 | Derived | Reichlin T, Kueffer T, Badertscher P, Juni P, Knecht S, Thalmann G, Kozhuharov N, Krisai P, Jufer C, Maurhofer J, Heg D, Pereira TV, Mahfoud F, Servatius H, Tanner H, Kuhne M, Roten L, Sticherling C; SINGLE SHOT CHAMPION Investigators. Pulsed Field or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2025 Apr 17;392(15):1497-1507. doi: 10.1056/NEJMoa2502280. Epub 2025 Mar 31. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| PVI using FARAPULSE Pulsed Field Ablation (Boston Scientific) | Device | Patients randomized to the Pulsed Field Ablation group will undergo PVI using the FARAPULSE PFA system (Boston Scientific). At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring. |
|
Procedural endpoint |
| Day 0 |
| Total left atrium indwelling time | Procedural endpoint | Day 0 |
| Total fluoroscopy time | Procedural endpoint | day 0 |
| Total radiation dose | Procedural endpoint | Day 0 |
| Contrast agent usage | Procedural endpoint | Day 0 |
| Increase in hsTroponin on day 1 post-ablation | Procedural endpoint | Day 1 |
| Proportion of isolated veins | Assessed by post-ablation 3D electro-anatomical mapping in the first 25 patients in each study group | Day 0 |
| Proportion of isolated carinas | Assessed by post-ablation 3D electro-anatomical mapping in the first 25 patients in each study group | Day 0 |
| Lesion size | Assessed by post-ablation 3D electro-anatomical mapping in the first 25 patients in each study group | Day 0 |
| Time to first recurrence of atrial tachyarrhythmia between days 1 and 90 after ablation | Time to first recurrence of any atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL] or atrial tachycardia [AT]) between days 1 and 90 post ablation as detected on continuous implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 s or longer on ICM (the minimum programmable episode interval). | Days 1 to 90 post-ablation |
| Arrhythmia burden evaluated based on continuous ICM (overall AF burden = % time in AF) | Assessed by the ICM Core Lab post implantation: between 0-90 days; 91-365 days, 365 days to explantation/end of life of the ICM | Between: 0-90 days, 91-365 days, 365 days up to 3.5 years |
| Arrhythmia being AF or organized atrial arrhythmias (atrial flutter or atrial tachycardias) | Comparison of the prevalence of the type of arrhythmia recurrences during follow-up being AF or organized atrial arrhythmias (AFL or AT) | 3, 12, 24 and 36 months follow up |
| Average heart rates | Average heart rates in ICM documentation in months 1, 2 and 3 after ablation | Months 1, 2 and 3 post-ablation |
| Proportion of patients admitted to the hospital or emergency room because of documented recurrence of atrial arrhythmias | Based on telephone follow-up | Postablation 3 months (+/- 2 weeks), 12 months (+/- 2 months), 24 months (+/- 2 months) and 36 months (+/- 2 months) |
| Proportion of patients undergoing electrical cardioversion because of documented recurrence of atrial arrhythmias | Based on telephone follow-up | Postablation 3 months (+/- 2 weeks), 12 months (+/- 2 months), 24 months (+/- 2 months) and 36 months (+/- 2 months) |
| Proportion of patients undergoing a repeat ablation procedure because of documented recurrence of atrial arrhythmias | Based on telephone follow-up | Postablation 3 months (+/- 2 weeks), 12 months (+/- 2 months), 24 months (+/- 2 months) and 36 months (+/- 2 months) |
| Reinitiation of antiarrhythmic drugs during follow-up | Reinitiation of antiarrhythmic drugs during follow-up based on telephone follow-up | Months 3, 12, 24 and 36 post-ablation |
| Number of reconnected veins evaluated during redo-procedures | During redo-procedure, expected to be on average 20-60 minutes |
| Evolution of Quality of Life through months 3 and 12 | QoL questionnaires (EQ-5D) will be sent to the patients by mail after 3 and 12 months to compare the evolution of QoL after the ablation | Months 3 and 12 post-ablation |
| Stroke including TIA after 3, 12, 24 and 36 months | Months 3, 12, 24 and 36 post-ablation |
| Death cardiovascular or non-cardiovascular after 3, 12, 24 and 36 months | Months 3, 12, 24 and 36 post-ablation |
| Sites (anatomical location) of vein reconnection assessed in study patients undergoing a Redo-Procedure at one of the study centres | During redo-procedure, expected to be on average 20-60 minutes |
| Size (area calculate in cm2) of antral scar area assessed in study patients undergoing a Redo-Procedure at one of the study centres | During redo-procedure, expected to be on average 20-60 minutes |
| Bern |
| 3010 |
| Switzerland |
| D013568 |
| Pathological Conditions, Signs and Symptoms |