HIgh Power Short Duration Radiofrequency Ablation or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation

  • End date
    Aug 1, 2023
  • participants needed
  • sponsor
    Universitätsklinikum Köln
Updated on 6 August 2021
radiofrequency ablation
paroxysmal atrial fibrillation
pulmonary vein isolation


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).


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.
  2. 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.

Condition Atrial Fibrillation and Flutter, Atrial Fibrillation, Atrial Fibrillation (Pediatric), Dysrhythmia, Arrhythmia, paroxysmal af, Paroxysmal Atrial Fibrillation
Treatment ablation
Clinical Study IdentifierNCT04855890
SponsorUniversitätsklinikum Köln
Last Modified on6 August 2021


Yes No Not Sure

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
Participation in other clinical studies
Unwilling to follow the study protocol and to attend follow-up visits
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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