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

  • STATUS
    Recruiting
  • End date
    Aug 1, 2023
  • participants needed
    170
  • sponsor
    Universitätsklinikum Köln
Updated on 6 August 2021
heparin
fibrillation
radiofrequency ablation
paroxysmal atrial fibrillation
pulmonary vein isolation

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).

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.
  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.

Details
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

Eligibility

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
Pregnancy
Participation in other clinical studies
Unwilling to follow the study protocol and to attend follow-up visits
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note