Inappropriate ICD TherapyPhase 2/3RISSY-ICDNCT02044315
Prevention of Inappropriate ICD Shocks
A Phase 2/3 study testing ICD programming in people with Inappropriate ICD Therapy and Appropriate ICD Therapy, run by Yuksek Ihtisas Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the present study is to investigate whether increasing detection zones can effectively reduce inappropriate ICD therapies in primary prevention patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inappropriate ICD Therapy, Appropriate ICD Therapy
- What is being tested?
- ICD programming
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2012to Dec 2012
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years
- Cardiomyopathy (ischemic or not)
- Current accepted indication for ICD implantation
Who cannot join
- Previous device implantation
- Secondary prevention patients
- Pregnancy,
- Primary electrical disorders,
- Patient refusal,
- <1 year of expected mortality
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yuksek Ihtisas Hospital
Ankara, Cankaya, 06100
About this study
The aim of the present study is to investigate whether increasing detection zones can effectively reduce inappropriate ICD therapies in primary prevention patients.
- Conditions
- Inappropriate ICD Therapy, Appropriate ICD Therapy
- Being tested
- ICD programming
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD programmingDevice
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Sham comparator | Conventional ICD programming Receives: Device: ICD programming |
| High-zone | Experimental | High-zone ICD programming Receives: Device: ICD programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
First total inappropriate therapy
Occurence of first total inappropriate therapy at 12-month follow-up
Measured: 12 months
Occurence of first total appropriate therapy at 12-month follow-up
Occurence of first total appropriate therapy at 12-month follow-up
Measured: 12 months
Secondary outcomes (2)
All-cause mortality
Occurence of all-cause mortality at 12-month follow-up
Measured: 12 months
Hospitalization for heart failure
Occurence of hospitalization for heart failure at 12-month follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inappropriate ICD TherapyStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuksek Ihtisas Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Cay, Yuksek Ihtisas Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044315
- Sponsor's protocol ID
- SNY-168
- Acronym
- RISSY-ICD
- Status last verified
- Jan 2014
- First submitted
- 21 Jan 2014
- Last updated
- 23 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Inappropriate ICD Shocks
- ClinicalTrials.gov ID
- NCT02044315
- Acronym / sponsor ID
- RISSY-ICD / SNY-168
- Conditions
- Inappropriate ICD Therapy, Appropriate ICD Therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Yuksek Ihtisas HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Jan 2014 (estimated)
- 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.
The aim of the present study is to investigate whether increasing detection zones can effectively reduce inappropriate ICD therapies in primary prevention patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Sham comparator | Device: ICD programmingConventional ICD programming |
| High-zone | Experimental | Device: ICD programmingHigh-zone ICD programming |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 18 years
- Cardiomyopathy (ischemic or not)
- Current accepted indication for ICD implantation
Key exclusion criteria (6 listed)
- Previous device implantation
- Secondary prevention patients
- Pregnancy,
- Primary electrical disorders,
- Patient refusal,
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 |
|---|---|---|
| ICD programming | Device | Conventional, High-zone |
Primary outcome
First total inappropriate therapy
Time frame: 12 months
Occurence of first total inappropriate therapy at 12-month follow-up
Occurence of first total appropriate therapy at 12-month follow-up
Time frame: 12 months
Occurence of first total appropriate therapy at 12-month follow-up
2 secondary outcomes
All-cause mortality
Time frame: 12 months
Hospitalization for heart failure
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2014.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ICD programming in people with Inappropriate ICD Therapy and Appropriate ICD Therapy, run by Yuksek Ihtisas Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 23 Jan 2014. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
First total inappropriate therapy (time frame: 12 months). The study lists 2 primary outcomes in all. 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 23 Jan 2014.