Heart FailureCASTLE-VTNCT06556485
Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure
A study testing Catheter ablation and Medical therapy in people with Heart Failure and Arrhythmia, Ventricular, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
Trial summary
CASTLE-VT is a randomized evaluation of prophylactic ablative treatment of arrhythmogenic ventricular scar in patients referred for HTx evaluation and diagnosed with ICM. Ablation will be performed with the use of a substrate-based approach in which the myocardial scar is mapped and ablated while the heart remains… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Failure, Arrhythmia, Ventricular, Cardiomyopathy Ischemic
- What is being tested?
- Catheter ablation and Medical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- 13 Sep 2024to 1 Jan 2027
- Phase
- Interventional
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic cardiomyopathy with left ventricular ejection fraction ≤ 35% (measured in the last 6 weeks prior to enrollment)
- Eligible for heart transplantation due to end-stage heart failure
- NYHA class ≥ III
- Impaired functional capacity or inability to exercise
- Indication for ICD therapy due to primary prevention
- Implanted ICD or ICD implantation within 3 months after randomization
- The patient is willing and able to comply with the protocol and has provided written informed consent
- Age ≥ 18 years
Who cannot join
- Previous catheter ablation for ventricular arrhythmias
- Previous appropriate ICD-therapy for ventricular arrhythmias
- Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 4 weeks prior to enrollment
- Untreated hypothyroidism or hyperthyroidism
- Woman currently pregnant, breastfeeding, or not using reliable contraceptive measures during fertility age
- Mental or physical inability to participate in the study
Show all 12Show fewer
- Listed as "high urgent" for heart transplantation
- Cardiac assist device implanted
- Planned cardiovascular intervention
- Life expectancy ≤ 12 month
- Uncontrolled hypertension
- Requirement for dialysis due to end-stage renal failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Clinic for Electrophysiology, Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545
Astrid Kleemeyer, 0495731971258, akleemeyer@hdz-nrw.de
Christian Sohns, MD
About this study
Official title: Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure rEfferred for Heart Transplantation eValuaTion (CASTLE-VT)
CASTLE-VT is a randomized evaluation of prophylactic ablative treatment of arrhythmogenic ventricular scar in patients referred for HTx evaluation and diagnosed with ICM. Ablation will be performed with the use of a substrate-based approach in which the myocardial scar is mapped and ablated while the heart remains predominantly in sinus rhythm. The primary end point is the composite of all-cause mortality, worsening of HF requiring prioritized transplantation or LVAD implantation. The main secondary study end points are all-cause mortality, cardiovascular mortality, incidence of implantable cardioverter-defibrillator (ICD) therapy, hospitalizations, Quality of life, time to first ICD therapy, number of device-detected ventricular tachycardia/ventricular fibrillation episodes, LV function, and exercise tolerance. CASTLE-VT will randomize 160 patients with a follow up period of 2 years.
- Conditions
- Heart Failure, Arrhythmia, Ventricular, Cardiomyopathy Ischemic, Catheter Ablation, Heart Transplantation, Left Ventricular Assist Device
- Being tested
- Catheter ablation, Medical therapy
- Medical subject headings
- Heart Failure, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationProcedure or surgery
Also called Ablation
Preventive ablation therapy
Medical therapyDrug
Also called Medical
Optimal medical therapy
| Study group | Role | What they receive |
|---|---|---|
| Ablation group | Active comparator | Primary prophylactic ablation Receives: Procedure: Catheter ablation |
| Control group | Active comparator | Optimal medical therapy Receives: Drug: Medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary end point
Composite of all-cause mortality, worsening of HF requiring prioritized transplantation or LVAD implantation
Measured: through study completion, an average of 2 years
Secondary outcomes (4)
Secondary end point 1
all-cause mortality, cardiovascular mortality
Measured: through study completion, an average of 2 years
Secondary end point 2
incidence of implantable cardioverter-defibrillator (ICD) therapy, hospitalizations, number of device-detected ventricular tachycardia/ventricular fibrillation episodes
Measured: through study completion, an average of 2 years
Secondary end point 3
Quality of life, time to first ICD therapy
Measured: through study completion, an average of 2 years
Secondary end point 4
LV function, exercise tolerance
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start13 Sep 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556485
- Sponsor's protocol ID
- HDZ-ER_004_CS
- Acronym
- CASTLE-VT
- Status last verified
- Nov 2024
- First submitted
- 17 Jul 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Catheter Ablation for Ventricular arrhythmiaS in Patients With End-sTage Heart faiLure rEfferred for Heart Transplantation eValuaTion (CASTLE-VT)
- ClinicalTrials.gov ID
- NCT06556485
- Acronym / sponsor ID
- CASTLE-VT / HDZ-ER_004_CS
- Conditions
- Heart Failure, Arrhythmia, Ventricular, Cardiomyopathy Ischemic, Catheter Ablation, Heart Transplantation, Left Ventricular Assist Device
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Heart and Diabetes Center North-Rhine WestfaliaUniversity, hospital or other
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 16 Aug 2024 (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.
CASTLE-VT is a randomized evaluation of prophylactic ablative treatment of arrhythmogenic ventricular scar in patients referred for HTx evaluation and diagnosed with ICM. Ablation will be performed with the use of a substrate-based approach in which the myocardial scar is mapped and ablated while the heart remains predominantly in sinus rhythm. The primary end point is the composite of all-cause mortality, worsening of HF requiring prioritized transplantation or LVAD implantation. The main secondary study end points are all-cause mortality, cardiovascular mortality, incidence of implantable cardioverter-defibrillator (ICD) therapy, hospitalizations, Quality of life, time to first ICD therapy, number of device-detected ventricular tachycardia/ventricular fibrillation episodes, LV function, and exercise tolerance. CASTLE-VT will randomize 160 patients with a follow up period of 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablation group | Active comparator | Procedure: Catheter ablationPrimary prophylactic ablation |
| Control group | Active comparator | Drug: Medical therapyOptimal medical therapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ischemic cardiomyopathy with left ventricular ejection fraction ≤ 35% (measured in the last 6 weeks prior to enrollment)
- Eligible for heart transplantation due to end-stage heart failure
- NYHA class ≥ III
- Impaired functional capacity or inability to exercise
- Indication for ICD therapy due to primary prevention
Key exclusion criteria (12 listed)
- Previous catheter ablation for ventricular arrhythmias
- Previous appropriate ICD-therapy for ventricular arrhythmias
- Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 4 weeks prior to enrollment
- Untreated hypothyroidism or hyperthyroidism
- Woman currently pregnant, breastfeeding, or not using reliable contraceptive measures during fertility age
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 |
|---|---|---|
| Catheter ablationAlso: AblationPreventive ablation therapy | Procedure or surgery | Ablation group |
| Medical therapyAlso: MedicalOptimal medical therapy | Drug | Control group |
Primary outcome
Primary end point
Time frame: through study completion, an average of 2 years
Composite of all-cause mortality, worsening of HF requiring prioritized transplantation or LVAD implantation
4 secondary outcomes
Secondary end point 1
Time frame: through study completion, an average of 2 years
Secondary end point 2
Time frame: through study completion, an average of 2 years
Secondary end point 3
Time frame: through study completion, an average of 2 years
Secondary end point 4
Time frame: through study completion, an average of 2 years
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 4 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation and Medical therapy in people with Heart Failure and Arrhythmia, Ventricular, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.
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 12 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 4 Dec 2024. 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 Germany. 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.
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 Christian Sohns, MD (49 5731 971327, csohns@hdz-nrw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary end point (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2024.