Ventricular TachycardiaPhase 2STARNL-2NCT05439031
StereoTactic Arrhythmia Radiotherapy in the NetherLands no. 2
A Phase 2 study testing Stereotactic Arrhythmia Radiotherapy in people with Ventricular Tachycardia and Arrythmia, Cardiac, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Arrythmia, Cardiac
- What is being tested?
- Stereotactic Arrhythmia Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 May 2023to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- History of radiation treatment in the thorax or upper abdominal region
- Interstitial pulmonary disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC location University of Amsterdam
Amsterdam, North Holland, 1105AZ
Pieter G Postema, MD PhD, 0031 20 566 4338 ext. 0031, p.g.postema@amsterdamumc.nl
About this study
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.
Read the detailed description
Ventricular tachycardia (VT) is a malignant cardiac arrhythmia leading to a sudden abolition of cardiac function directly followed by a shortage of oxygen supply to essential organs such as the brain and heart. For this reason, VT is a cardiac emergency and should be treated within seconds to minutes before irreversible and potentially fatal organ damage follows. Current treatment options are limited to anti-arrhythmic drugs, an implantable cardioverter defibrillator (ICD), and invasive catheter ablation. Unfortunately, invasive cardiac VT ablation has the lowest success rate and the highest complication rates among all arrhythmia ablations.
Since the first case series published by Cuculich et al. (2017) and the first prospective trial published by Robinson et al. (2019), stereotactic arrhythmia radiotherapy (STAR) has evolved as a new treatment modality for patients with ventricular tachycardia refractory to conventional therapies. Patients are treated with a single radiotherapy fraction of 25 Gy at the determined pro-arrhythmic cardiac region with the use of standard stereotactic radiotherapy techniques. Experience with STAR is steadily growing worldwide. In the systematic review by Van der Ree et al. (2020), a reduction of >85% in VT episodes with a simultaneously promising safety profile was shown.
The mechanism of action of STAR is not yet fully known and is yet to be elucidated. The pathophysiological mechanism of VT relies on re-entry due to zigzag conduction by the surviving myocardial fibers in previously damaged heart tissue. At first, it was hypothesized that inducing cell-death by ionizing radiation leads to dense transmural fibrosis. As mature myocardial fibrosis is not able to propagate electrical activation this may lead to the abolishment of the zigzag conduction herewith reducing the chance of re-entry and VT. Fibrosis maturation takes several weeks to months to complete. However, the anti-arrhythmic effects seem to occur earlier. In preclinical studies, early electrophysiological alterations were demonstrated (Zhang et al. 2021). The gap-junction protein connexion-43 (Cx43) and the voltage gated sodium channels were upregulated, leading to a supraphysiological state with increased conduction velocity. Since a slow conduction pathway is required for re-entry, this could explain the timing of the observed effect, although the exact mechanism of action remains to be elucidated.
In the STARNL-2 study we aim to confirm our STARNL-1 pilot (6 patients) efficacy and safety data in a larger cohort and obtain insights in the electro-anatomical alterations of stereotactic arrhythmia radiotherapy in patients with therapy refractory ventricular tachycardia.
- Conditions
- Ventricular Tachycardia, Arrythmia, Cardiac
- Being tested
- Stereotactic Arrhythmia Radiotherapy
- Keywords
- Ventricular Arrhythmias, Ventricular Tachycardia, Cardiac Radioablation, Stereotactic Radiotherapy, Stereotactic Arrhythmia Radiotherapy, Stereotactic body radiotherapy, Cardiac ablative radiotherapy
- Medical subject headings
- Tachycardia, Ventricular, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Arrhythmia RadiotherapyRadiation
Also called Cardiac Radioablation
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
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Arrhythmia Radiotherapy | Experimental | Patients will undergo stereotactic arrhythmia radiotherapy and subsequent follow-up. Receives: Radiation: Stereotactic Arrhythmia Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (6)
Reduction in the number of treated and non-treated VT episodes
Reduction in the number of treated and non-treated VT episodes by ≥70% at the end of follow-up compared to the year before treatment.
Measured: 18 months (excluding 3 months of blanking period)
Reduction in anti-arrhythmic drugs
A reduction of the daily dose by ≥50% (amiodarone or mexiletine) at the end of follow-up compared to baseline.
Measured: 12 months
Quality of Life improvement
Quality of life improvement of ≥25% in the categories health change and social functioning as measured by the SF-36 questionnaire at the end of follow-up compared to baseline.
Measured: 12 months
Cardiac safety
>25% relative decrease in left ventricular ejection fraction measured by echocardiography at end of follow-up as compared to baseline
Measured: 12 months
Pulmonary safety
>25% relative decrease in forced expiratory volume in 1 second (FEV1) measured by pulmonary functions tests at end of follow-up as compared to baseline.
Measured: 12 months
Pulmonary safety
>25% relative decrease in diffusing capacity (DLCO) measured by pulmonary functions tests at one year after treatment as compared to baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start19 May 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Heart Foundation
- Responsible party
- Principal investigator, Pieter G. Postema, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Pieter G Postema, MD PhD, Principal investigator, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439031
- Sponsor's protocol ID
- NL80617.018.22
- Acronym
- STARNL-2
- Status last verified
- Jan 2026
- First submitted
- 27 Jun 2022
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29236642Robinson 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.
PubMed 30586734van 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.
PubMed 32205299Zhang 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.
PubMed 34561429
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StereoTactic Arrhythmia Radiotherapy in the NetherLands no. 2
- ClinicalTrials.gov ID
- NCT05439031
- Acronym / sponsor ID
- STARNL-2 / NL80617.018.22
- Conditions
- Ventricular Tachycardia, Arrythmia, Cardiac
- Keywords
- Ventricular Arrhythmias, Ventricular Tachycardia, Cardiac Radioablation, Stereotactic Radiotherapy, Stereotactic Arrhythmia Radiotherapy, Stereotactic body radiotherapy, Cardiac ablative radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Dutch Heart Foundation
- Study start
- 19 May 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Ventricular tachycardia (VT) is a malignant cardiac arrhythmia leading to a sudden abolition of cardiac function directly followed by a shortage of oxygen supply to essential organs such as the brain and heart. For this reason, VT is a cardiac emergency and should be treated within seconds to minutes before irreversible and potentially fatal organ damage follows. Current treatment options are limited to anti-arrhythmic drugs, an implantable cardioverter defibrillator (ICD), and invasive catheter ablation. Unfortunately, invasive cardiac VT ablation has the lowest success rate and the highest complication rates among all arrhythmia ablations.
Since the first case series published by Cuculich et al. (2017) and the first prospective trial published by Robinson et al. (2019), stereotactic arrhythmia radiotherapy (STAR) has evolved as a new treatment modality for patients with ventricular tachycardia refractory to conventional therapies. Patients are treated with a single radiotherapy fraction of 25 Gy at the determined pro-arrhythmic cardiac region with the use of standard stereotactic radiotherapy techniques. Experience with STAR is steadily growing worldwide. In the systematic review by Van der Ree et al. (2020), a reduction of >85% in VT episodes with a simultaneously promising safety profile was shown.
The mechanism of action of STAR is not yet fully known and is yet to be elucidated. The pathophysiological mechanism of VT relies on re-entry due to zigzag conduction by the surviving myocardial fibers in previously damaged heart tissue. At first, it was hypothesized that inducing cell-death by ionizing radiation leads to dense transmural fibrosis. As mature myocardial fibrosis is not able to propagate electrical activation this may lead to the abolishment of the zigzag conduction herewith reducing the chance of re-entry and VT. Fibrosis maturation takes several weeks to months to complete. However, the anti-arrhythmic effects seem to occur earlier. In preclinical studies, early electrophysiological alterations were demonstrated (Zhang et al. 2021). The gap-junction protein connexion-43 (Cx43) and the voltage gated sodium channels were upregulated, leading to a supraphysiological state with increased conduction velocity. Since a slow conduction pathway is required for re-entry, this could explain the timing of the observed effect, although the exact mechanism of action remains to be elucidated.
In the STARNL-2 study we aim to confirm our STARNL-1 pilot (6 patients) efficacy and safety data in a larger cohort and obtain insights in the electro-anatomical alterations of stereotactic arrhythmia radiotherapy in patients with therapy refractory ventricular tachycardia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Arrhythmia Radiotherapy | Experimental | Radiation: Stereotactic Arrhythmia RadiotherapyPatients will undergo stereotactic arrhythmia radiotherapy and subsequent follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- History of radiation treatment in the thorax or upper abdominal region
- Interstitial pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Arrhythmia RadiotherapyAlso: Cardiac RadioablationSingle 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 | Radiation | Stereotactic Arrhythmia Radiotherapy |
Primary outcome
Reduction in the number of treated VT episodes
Time frame: 18 months (excluding 3 months of blanking period)
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.
Rate of treatment related serious adverse events (SAEs)
Time frame: 12 months
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.
6 secondary outcomes
Reduction in the number of treated and non-treated VT episodes
Time frame: 18 months (excluding 3 months of blanking period)
Reduction in anti-arrhythmic drugs
Time frame: 12 months
Quality of Life improvement
Time frame: 12 months
Cardiac safety
Time frame: 12 months
Pulmonary safety
Time frame: 12 months
Pulmonary safety
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Background: PubMed 29236642Cuculich 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.
- Background: PubMed 30586734Robinson 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.
- Background: PubMed 32205299van 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.
- Background: PubMed 34561429Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pieter G Postema, MD PhD principal investigator
University of Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Arrhythmia Radiotherapy in people with Ventricular Tachycardia and Arrythmia, Cardiac, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pieter G Postema, MD PhD (0031 20 566 4338 ext. 0031, p.g.postema@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the number of treated VT episodes (time frame: 18 months (excluding 3 months of blanking period)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05439031, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.