NCT05439031

Brief Summary

Ventricular tachycardia (VT) is a malignant cardiac arrhythmia subjecting our patients to a high risk of sudden death, increased morbidity and reduced quality of life. Unfortunately, failure of treatment is common and VT recurrences remain an important concern. In these patients, stereotactic arrhythmia radiotherapy appears to be an effective and safe treatment. The mechanism of action however remains unknown and should be elucidated. The objective of this phase 2, single arm, monocenter, pre-post intervention study is to evaluate the efficacy and safety of stereotactic arrhythmia radiotherapy and obtain insights in the mechanism of action by evaluating electro-anatomical alterations of stereotactic arrhythmia radiotherapy in patients with therapy refractory ventricular tachycardia.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
14mo left

Started May 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
May 2023Jul 2027

First Submitted

Initial submission to the registry

June 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

May 19, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

4.1 years

First QC Date

June 27, 2022

Last Update Submit

January 13, 2026

Conditions

Ventricular TachycardiaArrythmia, Cardiac

Keywords

Ventricular ArrhythmiasVentricular TachycardiaCardiac RadioablationStereotactic RadiotherapyStereotactic Arrhythmia RadiotherapyStereotactic body radiotherapyCardiac ablative radiotherapy

Outcome Measures

Primary Outcomes (2)

  • Reduction in the number of treated VT episodes

    The main efficacy measure is a reduction in the number of treated VT episodes by ≥50% at the end of follow-up of 1 year (including a blanking period of 3 months). Net follow-up is 9 months compared to 9 months before treatment.

    18 months (excluding 3 months of blanking period)

  • Rate of treatment related serious adverse events (SAEs)

    The main safety measure is defined by a ≤20% rate of treatment related serious adverse events (SAEs), determined as the number of treatment related serious adverse events per number of treatment related adverse events.

    12 months

Secondary Outcomes (6)

  • Reduction in the number of treated and non-treated VT episodes

    18 months (excluding 3 months of blanking period)

  • Reduction in anti-arrhythmic drugs

    12 months

  • Quality of Life improvement

    12 months

  • Cardiac safety

    12 months

  • Pulmonary safety

    12 months

  • +1 more secondary outcomes

Study Arms (1)

Stereotactic Arrhythmia Radiotherapy

EXPERIMENTAL

Patients will undergo stereotactic arrhythmia radiotherapy and subsequent follow-up.

Radiation: Stereotactic Arrhythmia Radiotherapy

Interventions

Stereotactic Arrhythmia RadiotherapyRADIATION

Single radiation treatment of 25 Gy with external beam radiation therapy to the pro-arrhythmic region as determined by the cardiologist-electrophysiologist and radiation-oncologist combined

Also known as: Cardiac Radioablation
Stereotactic Arrhythmia Radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Implanted ICD
  • World Health Organization (WHO) / Eastern Cooperative Oncology Group (ECOG) performance status grade 0-3 in the past 3 months (from fully active to capable of limited self-care, see below for full explanation)
  • At least 3 episodes of treated VT within the last 3 months
  • Recurrence of VT after
  • Failed or intolerant to least one class 1 or class 3 anti-arrhythmic drug AND
  • At least one catheter ablation procedure OR considered to be unsuitable for a catheter ablation procedure (e.g. no sufficient vascular access, considered unfit to undergo prolonged general anesthesia, comorbid conditions resulting in unacceptable peri-procedural risks)
  • Able and willing to undergo all necessary evaluations, treatment and follow-up for the study and of follow-up thereafter

You may not qualify if:

  • Pregnancy
  • History of radiation treatment in the thorax or upper abdominal region
  • Interstitial pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC location University of Amsterdam

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

Related Publications (4)

  • Cuculich PS, Schill MR, Kashani R, Mutic S, Lang A, Cooper D, Faddis M, Gleva M, Noheria A, Smith TW, Hallahan D, Rudy Y, Robinson CG. Noninvasive Cardiac Radiation for Ablation of Ventricular Tachycardia. N Engl J Med. 2017 Dec 14;377(24):2325-2336. doi: 10.1056/NEJMoa1613773.

    PMID: 29236642BACKGROUND

  • Robinson CG, Samson PP, Moore KMS, Hugo GD, Knutson N, Mutic S, Goddu SM, Lang A, Cooper DH, Faddis M, Noheria A, Smith TW, Woodard PK, Gropler RJ, Hallahan DE, Rudy Y, Cuculich PS. Phase I/II Trial of Electrophysiology-Guided Noninvasive Cardiac Radioablation for Ventricular Tachycardia. Circulation. 2019 Jan 15;139(3):313-321. doi: 10.1161/CIRCULATIONAHA.118.038261.

    PMID: 30586734BACKGROUND

  • van der Ree MH, Blanck O, Limpens J, Lee CH, Balgobind BV, Dieleman EMT, Wilde AAM, Zei PC, de Groot JR, Slotman BJ, Cuculich PS, Robinson CG, Postema PG. Cardiac radioablation-A systematic review. Heart Rhythm. 2020 Aug;17(8):1381-1392. doi: 10.1016/j.hrthm.2020.03.013. Epub 2020 Mar 20.

    PMID: 32205299BACKGROUND

  • Zhang DM, Navara R, Yin T, Szymanski J, Goldsztejn U, Kenkel C, Lang A, Mpoy C, Lipovsky CE, Qiao Y, Hicks S, Li G, Moore KMS, Bergom C, Rogers BE, Robinson CG, Cuculich PS, Schwarz JK, Rentschler SL. Cardiac radiotherapy induces electrical conduction reprogramming in the absence of transmural fibrosis. Nat Commun. 2021 Sep 24;12(1):5558. doi: 10.1038/s41467-021-25730-0.

    PMID: 34561429BACKGROUND

MeSH Terms

Conditions

Tachycardia, VentricularArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

TachycardiaHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pieter G Postema, MD PhD

    University of Amsterdam

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pieter G Postema, MD PhD

CONTACT

0031 20 566 4338p.g.postema@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 27, 2022

First Posted

June 30, 2022

Study Start

May 19, 2023

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)