Optimal Antitachycardia Therapy in ICD Patients without Pacing Indications

Phase 4

• Conditions: 10007521; cardiac arrest; heart rhythm disorders

• Registration Number: NL-OMON30671
• Lead Sponsor: ELA Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1. Patient has been prescribed the implantation for an ICD system accordingly to the relevant currently-approved ACC/AHA guidelines1 (Appendix L) or ESC guidelines35 (Appendix M) or any relevant currently-approved local guidelines for the implantation of an ICD-system
2. Impaired left ventricular function demonstrated by a left-ventricular ejection fraction (LVEF) <= 40 %, measured by angio-scintigraphy, echocardiography, or contrast ventriculogram.
3. An optimal (as determined by the enrolling physician) medical regimen.
4. Patient has received all relevant information on the study, and has signed and dated a consent form.

Exclusion Criteria

1. Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing.
2. Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 (Appendix L) or ESC35 (Appendix M) guidelines for the implantation of a CRT system.
3. Any contraindication for ICD therapy and the implant of a dual chamber ICD.
4. ICD replacement
5. Chronic atrial arrhythmias or cardioversion for atrial fibrillation within the past month.
6. A PR interval > 250 ms or AR interval > 300 ms measured at implant.
7. Hypertrophic obstructive cardiomyopathy.
8. Acute myocarditis.
9. Unstable coronary symptoms or myocardial infarction within the last month.
10. Recent (within the last month) or planned cardiac revascularization or coronary angioplasty.
11. recently performed (in the last month) or planned cardiac surgery
12. Already included in another clinical study.
13. Life expectancy less than 24 months.
14. Inability to understand the purpose of the study or refusal to cooperate.
15. Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization.
16. Unavailability for scheduled follow-up at the implanting or cooperating center.
17. Age of less than 18 years.
18. Pregnancy

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to evaluate the clinical outcome of<br /><br>dual-chamber ICD therapy with minimized ventricular pacing compared with<br /><br>single-chamber device therapy with settings which are common in clinical<br /><br>practice. The outcome measure is the number of inappropriate shock therapy and<br /><br>a combined end point of all-cause mortality, hospitalisation for specified<br /><br>cardiac reasons (CHF, symptomatic AF, cardioversions for AF*, stroke,<br /><br>under-detected VT) and. Refer to 3.2.1 paragraph for more details.<br /><br>It is hypothesized that rate for unwanted clinical events is lower in the<br /><br>dual-chamber group than in the single-chamber group. In detail: the number of<br /><br>inappropriate shock therapies is lower in the dual-chamber arm but the rate of<br /><br>all cause mortality, hospitalisation for cardiac reasons as specified above is<br /><br>equal for both groups.</p><br>