Atrial Fibrillation, Atrial Fibrillation and Flutter, Paroxysmal Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, high power short duration, pulmonary vein isolation, cryo-ablation
Brief summary
Pulmonary vein isolation (PVI) using the cryoballoon has been proven equal to RF-PVI and is widely used. High Power Short Duration Ablation in RF-PVI has been successfully tested in several trials. Prospective data comparing both strategies is lacking. This trial will compare acute success rates, safety and foremost long-term outcome of two different PVI strategies (HPSD-PVI vs. cryo-PVI).
Detailed description
In several trials and real-life data pulmonary vein isolation (PVI) using the cryoballoon technique has been proven equal to RF-PVI for the treatment of paroxysmal atrial fibrillation (PAF). Due to the single-shot character of the device and shorter procedure times the cryoballoon is being widely used for PVI within the last years. However, additional endpoints such as non-excitability of the ablation line and consecutive arrhythmias may not be targeted properly by this device also lacking a detailed contact map to evaluate potential fibrotic areas. For the past decade, the use of RF energy for successful PVI has been the gold standard. However, ablation time and potential gaps within the circumferential ablation line are still an issue. High power (70 Watts) over short duration (7s) (HPSD) is a recently introduced RF-PVI concept. It has been shown to be as effective as conventional RF-PVI with equal safety features, shorter procedure durations and a superior long-term outcome. Therefore, HPSD-PVI in combination with the endpoint of non-excitability is potentially superior with regard to freedom of atrial arrhythmia during long-term FU compared to cryo-PVI with similar procedure times. So far, randomized prospective data comparing HPSD versus cryo-PVI are lacking. The aim of this prospective randomized study is to compare acute success rates, safety and foremost long-term outcome of two different PVI strategies (HPSD-PVI vs. cryo-PVI): 1\. To find the safest and most effective treatment strategy for PAF patients. 2. To evaluate the risk of complications for both treatment strategies. 3\. Evaluation of procedure endpoints like duration, costs and radiation dose. The present study is a mono-center prospective randomized study enrolling 170 patients with PAF and no prior Ablation for AF. Patients will be randomized to one of the following groups. Group A: Cryo-Ablation PVI will be performed using a Cryo-balloon. Group B: High-Power-Short-Duration PVI will be performed using HPSD RF-ablation. (70W over 5s posterior and 7s anterior) Catheter ablation procedures will be performed with commercially available devices including 3D mapping systems (EnSite, Abbott) and irrigated radiofrequency current (RFC) ablation or cryothermal balloon ablation (Arctic Front Advance Pro, Medtronic). The study shall start enrolling patients in April 2021. The last patient shall be enrolled in January 2023. Since follow-up is 12 months, end of study is planned for January 2024.
Interventions
PROCEDUREAblation
The ablation procedure will be performed during deep sedation using midazolam, fentanyl and a continuous infusion of propofol. Vital parameters will be monitored. For catheter access three 8F sheaths will be inserted into the femoral veins. A multipolar diagnostic catheter will be placed in the coronary sinus. Single transseptal puncture and insertion of a 8.5 F transseptal sheath or 12F Cryo-Sheath (FlexCath AdvanceTM, Medtronic, Minneapolis, MN, USA) will be followed by PV angiographies. Before or shortly after transseptal puncture unfractionated heparin will be repeatedly administered to maintain an activated clotting time between 250 and 400s.
Sponsors
Universitätsklinikum Köln
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The present study is a mono-center prospective randomized study enrolling 170 patients with PAF and no prior Ablation for AF. Patients will be randomized to one of the following groups. Group A: Cryo-Ablation PVI will be performed using a Cryo-balloon. Group B: High-Power-Short-Duration PVI will be performed using HPSD RF-ablation. (70W over 5s posterior and 7s anterior) Catheter ablation procedures will be performed with commercially available devices including 3D mapping systems (EnSite, Abbott) and irrigated radiofrequency current (RFC) ablation or cryothermal balloon ablation (Arctic Front Advance Pro, Medtronic).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic non-valvular atrial fibrillation with no prior ablation with an indication for re-ablation according to current guidelines. * Age 18-85 years. * Patient is able to provide informed consent and is willing to comply with the study protocol.
Exclusion criteria
* Contraindications for left atrial ablation * History of interventional or surgical AF-ablation * History of stroke during the past 12 months * BMI \>40kg/m2 * History of mitral valve surgery * Severe mitral valve regurgitation * Inability to be treated with oral anticoagulation * Presence of intracardiac thrombi * Contraindication or absolute indication for one of the two strategies * Pregnancy * Participation in other clinical studies * Unwilling to follow the study protocol and to attend follow-up visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of atrial arrhythmia | 12 months after a 3 months blanking period | Combined primary endpoint of recurrent atrial arrhythmia, onset of new AAD or re- ablation of atrial arrhythmia during the follow-up of 12 months after a 3-months blanking period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Periprocedural complications | Within 48 hours of procedure | Incidence of peri-procedural complications such as: major bleeding requiring intervention, phrenic nerve palsy, pericardial tamponade, thrombembolic events, death. |
| Number of re-hospitalisations | 12 months after a 3 months blanking period | Number of re-hospitalisations (total and for cardiovascular reasons) |
| Cardioversions | 12 months after a 3 months blanking period | Number of electrical cardioversions |
| Procedural data | During the procedure | Procedure duration, radiation dose, radiation duration |
Countries
Germany
Contacts
Primary ContactJonas Wörmann
Backup ContactArian Sultan, PD Dr.
Outcome results
None listed