- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03622307
Subcutaneous ICD Therapy Combined With VT Ablation for the Secondary Prevention of Sudden Cardiac Death
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- NYHA class IV or need for mechanical LV support (ECMO)
- Pregnancy or nursing
- Unwilling or unable to give informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: S-ICD therapy combined with VT Ablation
To evaluate the feasibility and safety of a management approach that incorporates VT-ablation and S-ICD implantation in secondary prevention patients
|
S-ICD implantation and VT ablation/substrate modification among patients with a secondary prevention indication for an ICD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appropriate ICD therapy
Time Frame: 24 months
|
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. |
24 months
|
Inappropriate ICD therapy
Time Frame: 24 months
|
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. |
24 months
|
Ablation success rates
Time Frame: 24 months
|
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.
|
24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All cause mortality
Time Frame: 24 months
|
Rate of all cause mortality.
This will be assessed during patient follow up.
|
24 months
|
Cardiac mortality
Time Frame: 24 months
|
Rate of all cardiac mortality.
This will be assessed during patient follow up.
|
24 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VT ablation/SICD study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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