Primary study objective:The primary objective of this study is to evaluate the clinical outcome of dual-chamber ICD therapy with minimized ventricular pacing compared with single-chamber device therapy with settings which are common in clinical…
ID
Source
Brief title
Study name: OPTION Study
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to evaluate the clinical outcome of
dual-chamber ICD therapy with minimized ventricular pacing compared with
single-chamber device therapy with settings which are common in clinical
practice. The outcome measure is the number of inappropriate shock therapy and
a combined end point of all-cause mortality, hospitalisation for specified
cardiac reasons (CHF, symptomatic AF, cardioversions for AF*, stroke,
under-detected VT) and. Refer to 3.2.1 paragraph for more details.
It is hypothesized that rate for unwanted clinical events is lower in the
dual-chamber group than in the single-chamber group. In detail: the number of
inappropriate shock therapies is lower in the dual-chamber arm but the rate of
all cause mortality, hospitalisation for cardiac reasons as specified above is
equal for both groups.
Secondary outcome
1. all cause mortality and cardio-vascular related mortality
2. Report Hospitalizations due to cardio-vascular event (specified for each
type of event)
3. Report time to first occurrence of inappropriate ICD shock therapy
4. Evaluation of the impact of the different therapies on quality of life and
heart failure status
5. Report sensitivity and specificity for the applied VT/SVT discrimination for
the first 100 patients in each group who complete their 27 months follow up
with a demonstrated correct pacing/sensing functioning
6. Report the inappropriate overall device reactions defined by inappropriate
shock and/or ATP therapy or inappropriate therapy delay/inhibition > 2 minutes
7. Report the time to first documented occurrence of permanent or persistent
AF* and number of patients moving into permanent AF
8. Report the cardiac dimensions obtained via echocardiography for a subset of
patients of both study groups at baseline and after 27 months
9. Report Slow VT incidence
10. Report unscheduled visits and hospitalizations due to slow VT
11. Report system-related complications (see section 2.3.9 for definition)
12. Report the mean and median cumulative percentage of ventricular pacing for
both study groups, and the % of pats with <1% V pacing.
13. Report the overall success rate of ATP in the FVT zone
14. Describe the cost-effectiveness for both study groups
15. Determination of the PPV and NPV for Tvar risk stratification to identify
patients at risk to develop VT/VF during follow up for the overall study
population.
Background summary
This study evaluates the impact of a new pacing mode avoiding unnecessary
ventricular stimulation in combination with advanced dual chamber detection
with slow VT management on the clinical outcome for hospitalization and
mortality and inadequate therapy in medically stable, ICD-indicated patients
with impaired left ventricular function (LVEF <= 40%) who do not have pacing
indications and no indication for Cardiac Resynchronization Therapy (CRT). It
compares a new pacing mode avoiding ventricular stimulation when not needed
combined with dual chamber detection with a pure ventricular back up pacing and
single chamber detection criteria with pure ventricular back up pacing.
Therapies are compared in a prospective, randomized, single-blinded, parallel
trial with a 24-month randomized treatment period. Randomization follows a 1:1
ratio. ICD therapy is enabled for all patients throughout the study. All
patients receive optimal drug therapy for arrhythmia and heart failure
treatment.
Study objective
Primary study objective:
The primary objective of this study is to evaluate the clinical outcome of
dual-chamber ICD therapy with minimized ventricular pacing compared with
single-chamber device therapy with settings which are common in clinical
practice.
The outcome measure is the number of inappropriate shock therapy and a combined
end point of all-cause mortality, hospitalisation for specified cardiac reasons
(CHF, symptomatic AF, cardioversions for AF*, stroke, under-detected VT)
It is hypothesized that rate for unwanted clinical events is lower in the
dual-chamber group than in the single-chamber group. In detail: the number of
inappropriate shock therapies is lower in the dual-chamber arm but the rate of
all cause mortality, hospitalisation for cardiac reasons as specified above is
equal for both groups.
Secondary study objectives are:
1. all cause mortality and cardio-vascular related mortality
2. Report Hospitalizations due to cardio-vascular event (specified for each
type of event)
3. Report time to first occurrence of inappropriate ICD shock therapy
4. Evaluation of the impact of the different therapies on quality of life and
heart failure status
5. Report sensitivity and specificity for the applied VT/SVT discrimination for
the first 100 patients in each group who complete their 27 months follow up
with a demonstrated correct pacing/sensing functioning
6. Report the inappropriate overall device reactions defined by inappropriate
shock and/or ATP therapy or inappropriate therapy delay/inhibition > 2 minutes
7. Report the time to first documented occurrence of permanent or persistent
AF* and number of patients moving into permanent AF
8. Report the cardiac dimensions obtained via echocardiography for a subset of
patients of both study groups at baseline and after 27 months
9. Report Slow VT incidence
10. Report unscheduled visits and hospitalizations due to slow VT
11. Report system-related complications (see section 2.3.9 for definition)
12. Report the mean and median cumulative percentage of ventricular pacing for
both study groups, and the % of pats with <1% V pacing.
13. Report the overall success rate of ATP in the FVT zone
14. Describe the cost-effectiveness for both study groups
Study design
After admitting the patients to the study, this by checking the in-and
exclusion criteria and the informed consent given by the patient, the patient
will be randomised before implant to the optimal treatment group (AAIsafeR 60
plus dual chamber detection with a TDI set to 500 ms and at least ATP
activated) or control group (VVI 40 plus optimized single chamber detection
with at least a monitoring detection zone TDI set to 500 ms). Programming of
therapies and an additional detection zone is left to physicians choice.
Study burden and risks
Normal risks associated with the implant of an implantable defibrillator.
Bastiaan de Zeeuwstraat 8
3227 AC OUdenhoorn
Nederland
Bastiaan de Zeeuwstraat 8
3227 AC OUdenhoorn
Nederland
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL15693.067.06 |