Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias

  • STATUS
    Recruiting
  • End date
    Jul 1, 2023
  • participants needed
    20
  • sponsor
    University Hospital Schleswig-Holstein
Updated on 1 September 2021
heart disease
shock
implantable cardioverter-defibrillators
catheter ablation
antiarrhythmic drug
premature ventricular contractions

Summary

Patients with refractory ventricular extrasystoles or tachycardia not eligible for catheter ablation will receive single fraction stereotactic body radiation therapy (cardiac radiosurgery) with 25 Gy.

Investigators initiated this study to demonstrate that in at least 70% of the patients the planned cardiac radiosurgery may be performed without any interruption or treatment related interventional events within the first 30 days after treatment.

Description

Primary endpoint: 30-day post-intervention safety defined as presence of both, radiosurgery delivery of the planned dose to the intended target area, and no possibly treatment related serious adverse events in the first 30 days after treatment.

Secondary endpoints: evaluated at 1 year

  • Changes in ventricular tachycardia episodes and ICD shocks
  • Changes in antiarrhythmic medication due to treatment effects
  • Occurrence of possibly treatment related adverse events in the first year after treatment (according to CTCAE v5.0)
  • Changes in patient-reported quality of life (recorded as EQ-5D-5L)
  • Overall survival
  • Safety profile

Details
Condition Tachycardia, Ventricular tachycardia, Fast Heart Rate (Tachycardia)
Treatment Cardiac Radiosurgery
Clinical Study IdentifierNCT03867747
SponsorUniversity Hospital Schleswig-Holstein
Last Modified on1 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with structural heart disease and implantable cardioverter defibrillator (ICD)
Age > 18 years
either
Recurring symptomatic monomorphic ventricular tachycardia that requires ICD intervention (e.g. shock or anti-tachycardia stimulation). At least 3 episodes within the 3 months prior to inclusion or
induction of symptomatic monomorphic ventricular tachycardia that requires ICD intervention (e.g. shock or anti-tachycardia stimulation). Induction triggered by ICD or during electrophysiology studies (EPS) or both, a) and b)
Refractory to antiarrhythmic combination therapy
Beside the cardiac conditions: No competing illness that would additionally limit the life expectancy to less than 6 months
No prior radiation therapy in the thorax area
No pregnancy and no active breastfeeding
Ability to consent and consent to study participation

Exclusion Criteria

ICD electrode malfunction of ICD readings outside reference range
Lack of evidence of a myocardial scar (Computer tomography or magnetic resonance tomography for MRI-capable ICD aggregates or electrophysiological measurement)
No possible induction of symptomatic monomorphic ventricular tachycardia non-persistent or persistent with delivery of ICD therapies such as antitachycardic pacing or shock
Contraindication to radiosurgery (e.g. precise target volume definition not possible due to image artifacts created from a left ventricular assist device [LVAD])
Inability to consent or missing or withdrawn consent
Clear my responses

How to participate?

Step 1 Connect with a site
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
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

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