Sudden Cardiac DeathNCT03622307
Subcutaneous ICD Therapy Combined With VT Ablation for the Secondary Prevention of Sudden Cardiac Death
A study testing Subcutaneous ICD Therapy Combined with VT Ablation in people with Sudden Cardiac Death, run by Sheba Medical Center.
Trial summary
This study evaluates the feasibility and safety of a management approach that incorporates VT-ablation and S-ICD implantation in secondary prevention patients. This is a single arm prospective study with 30 patients eligible for implantation of an ICD for the secondary prevention of sudden cardiac death. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Sudden Cardiac Death
- What is being tested?
- Subcutaneous ICD Therapy Combined with VT Ablation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any scar related sustained VT or VF
- Class I, IIa, or IIb indication for secondary prevention ICD therapy per ESC Guidelines
- Age ≥ 22 years on a date of consent
- LVEF ≤ 40%
- Positive ECG screening for S-ICD
Who cannot join
- A requirement for antibradycardia pacing or CRTD
- Subjects with an existing ICD, CRT, CRT-D, or pacemaker device.
- Contraindications for S-ICD implantation
- Contraindications for VT ablation
- Serious known concomitant disease with a life expectancy of < 1 year
- Elderly patients >80 years of age
Show all 9Show fewer
- NYHA class IV or need for mechanical LV support (ECMO)
- Pregnancy or nursing
- Unwilling or unable to give informed consent
About this study
This study evaluates the feasibility and safety of a management approach that incorporates VT-ablation and S-ICD implantation in secondary prevention patients. This is a single arm prospective study with 30 patients eligible for implantation of an ICD for the secondary prevention of sudden cardiac death.
Read the detailed description
The subcutaneous ICD (S-ICD) is a system without transvenous leads that has been proven to safely provide defibrillation for patients at risk of sudden cardiac death due to ventricular tachyarrhythmias. However this system is currently not able to perform anti tachycardia pacing (ATP) which can terminate some VT, thus avoiding painful shocks.
Ideally slow VT should be managed with RF ablation while fast VT causing hemodynamic consequences should be treated with ICD shocks combined with medications. Typically, ICDs in secondary prevention patients are programmed to intervene at 10 msec at least above the clinical VT. In cases of hemodynamically stable VT this can result in unnecessary therapies and lead to ICD shocks. S-ICD can safely manage fast VTs while slower hemodynamically VTs can be managed with ablation.
This approach can avoid transvenous ICD related complications and unnecessary ICD interventions such as ATP which can accelerate VT to ICD shock zone. However, the benefit of this management strategy compared to conventional transvenous ICD programming has not been studied in patients who receive the device for the secondary prevention of sudden cardiac death.
- Conditions
- Sudden Cardiac Death
- Being tested
- Subcutaneous ICD Therapy Combined with VT Ablation
- Keywords
- Subcutaneous ICD Therapy, VT Ablation
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous ICD Therapy Combined with VT AblationDevice
S-ICD implantation and VT ablation/substrate modification among patients with a secondary prevention indication for an ICD
| Study group | Role | What they receive |
|---|---|---|
| S-ICD therapy combined with VT Ablation | Experimental | To evaluate the feasibility and safety of a management approach that incorporates VT-ablation and S-ICD implantation in secondary prevention patients Receives: Device: Subcutaneous ICD Therapy Combined with VT Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
arrhythmic event
Occurrence of treated arrhythmic event (appropriate and inappropriate). The primary endpoint will be assessed by patient interview, clinical examination, and regularly scheduled SICD interrogation during follow-up
Measured: 24 months
Secondary outcomes (3)
Appropriate ICD therapy
Rate of appropriate ICD therapy (defined as a shock therapy for ventricular tachycardia or fibrillation).
This will be assessed by patient interview and regularly scheduled ICD interrogation during follow-up.
Measured: 24 months
Inappropriate ICD therapy
Rate of inappropriate therapy (defined as any ICD shock delivered for Non-VT event).
This will be assessed by patient interview and regularly scheduled ICD interrogation during follow-up.
Measured: 24 months
Ablation success rates
Rate of ablation success (defined as absence of Ventricular Arrhythmia). This will be assessed by patient interview and regularly scheduled ICD interrogation during follow-up.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study startOct 2018 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Eyal Nof, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622307
- Sponsor's protocol ID
- VT ablation/SICD study
- Status last verified
- Aug 2018
- First submitted
- 5 Jun 2018
- Last updated
- 24 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous ICD Therapy Combined With VT Ablation for the Secondary Prevention of Sudden Cardiac Death
- ClinicalTrials.gov ID
- NCT03622307
- Acronym / sponsor ID
- VT ablation/SICD study
- Conditions
- Sudden Cardiac Death
- Keywords
- Subcutaneous ICD Therapy, VT Ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Oct 2018 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 9 Aug 2018 (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.
This study evaluates the feasibility and safety of a management approach that incorporates VT-ablation and S-ICD implantation in secondary prevention patients. This is a single arm prospective study with 30 patients eligible for implantation of an ICD for the secondary prevention of sudden cardiac death.
Detailed description
The subcutaneous ICD (S-ICD) is a system without transvenous leads that has been proven to safely provide defibrillation for patients at risk of sudden cardiac death due to ventricular tachyarrhythmias. However this system is currently not able to perform anti tachycardia pacing (ATP) which can terminate some VT, thus avoiding painful shocks.
Ideally slow VT should be managed with RF ablation while fast VT causing hemodynamic consequences should be treated with ICD shocks combined with medications. Typically, ICDs in secondary prevention patients are programmed to intervene at 10 msec at least above the clinical VT. In cases of hemodynamically stable VT this can result in unnecessary therapies and lead to ICD shocks. S-ICD can safely manage fast VTs while slower hemodynamically VTs can be managed with ablation.
This approach can avoid transvenous ICD related complications and unnecessary ICD interventions such as ATP which can accelerate VT to ICD shock zone. However, the benefit of this management strategy compared to conventional transvenous ICD programming has not been studied in patients who receive the device for the secondary prevention of sudden cardiac death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S-ICD therapy combined with VT Ablation | Experimental | Device: Subcutaneous ICD Therapy Combined with VT AblationTo evaluate the feasibility and safety of a management approach that incorporates VT-ablation and S-ICD implantation in secondary prevention patients |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Any scar related sustained VT or VF
- Class I, IIa, or IIb indication for secondary prevention ICD therapy per ESC Guidelines
- Age ≥ 22 years on a date of consent
- LVEF ≤ 40%
- Positive ECG screening for S-ICD
Key exclusion criteria (9 listed)
- A requirement for antibradycardia pacing or CRTD
- Subjects with an existing ICD, CRT, CRT-D, or pacemaker device.
- Contraindications for S-ICD implantation
- Contraindications for VT ablation
- Serious known concomitant disease with a life expectancy of < 1 year
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 |
|---|---|---|
| Subcutaneous ICD Therapy Combined with VT AblationS-ICD implantation and VT ablation/substrate modification among patients with a secondary prevention indication for an ICD | Device | S-ICD therapy combined with VT Ablation |
Primary outcome
arrhythmic event
Time frame: 24 months
Occurrence of treated arrhythmic event (appropriate and inappropriate). The primary endpoint will be assessed by patient interview, clinical examination, and regularly scheduled SICD interrogation during follow-up
3 secondary outcomes
Appropriate ICD therapy
Time frame: 24 months
Inappropriate ICD therapy
Time frame: 24 months
Ablation success rates
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
Related trials for Sudden Cardiac Death
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Recruiting
ODSSEY-SCD_Identification Of Markers to preDict the rISk of Sudden Cardiac Death in Moderated LVEF in ischEmic cardiomyopathY
Myocardial Infarction (MI), Sudden Cardiac Death Due to Cardiac Arrhythmia
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous ICD Therapy Combined with VT Ablation in people with Sudden Cardiac Death, run by Sheba Medical Center.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arrhythmic event (time frame: 24 months). 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 24 Aug 2018.