Ventricular ArrythmiaEFICAZNCT03632057
Shock Efficacy Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population
A study testing Fixed Tilt (65%) and Fixed Pulse Width in people with Ventricular Arrythmia, run by Abbott Medical Devices at 2 sites in Spain.
Trial summary
This is a prospective, 1:1 randomized, interventional, multicenter and international trial. Approximately 790 subjects are expected to be enrolled to 40 sites in the south of Europe and Middle East. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrythmia
- What is being tested?
- Fixed Tilt (65%) and Fixed Pulse Width
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 779 participants
- Where
- 2 sitesSpain
- Study dates
- 6 Jun 2018to 18 Apr 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who meet the current ESC indications for ICD or CRT-D implant. This includes upgrades indications from pacemaker to ICD or to CRT-D or replacements of ICDs or CRT-Ds provided that there is no previous record of ineffective shocks
- Subjects who are willing to be registered on the Merlin.net remote follow-up program
- Subject ≥18 years
- Subjects with life expectancy of at least 1 year
- Subjects who agree to comply with the follow-up program included in this protocol
Who cannot join
- • Subjects on the waiting list for a heart transplant or under consideration for a transplant over the next 12 months
- Subjects with Myocardial infarction or unstable angina within 40 days prior to enrollment
- Subjects who have undergone a recent cardiac revascularization (PTCA, Stent or CABG) procedure in the 4 weeks prior to enrollment
- Functional NYHA Class IV
- Subjects who are participating in another ICD or CRT-D study
- Subjects who are pregnant at the time of enrollment or women of childbearing potential that do not take contraceptives
- Any disability or limitations to correctly understand or complete the study (physical, intellectual, logistical)
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Puerta de Hierro
Madrid
Hospital Virgen de la Victoria
Málaga, Andalusia
About this study
Official title: Shock Efficacy, a Randomized Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population
This is a prospective, 1:1 randomized, interventional, multicenter and international trial. Approximately 790 subjects are expected to be enrolled to 40 sites in the south of Europe and Middle East.
Read the detailed description
The objective of this study is to evaluate and compare the efficacy of the first appropriate shock of an ICD in a ventricular tachyarrhythmia, when the waveform of the shock is programmed with the standard waveform, Fixed Tilt with a value of 65% (Control Group), versus the exclusive waveform programmable in SJM ICDs, Fixed Pulse Width (Study Group), in a standard population of subjects with ICD indication.
- Conditions
- Ventricular Arrythmia
- Being tested
- Fixed Tilt (65%), Fixed Pulse Width
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed Tilt (65%)Device
This is the standard group, so device programming for shock energy is the default setting
Fixed Pulse WidthDevice
The device has to be programmed with fixed pulse width for each phase of the biphasic waveform
| Study group | Role | What they receive |
|---|---|---|
| Fixed Tilt (65%) | Active comparator | This is the control group, so device programming for shock energy is the default setting Receives: Device: Fixed Tilt (65%) |
| Fixed Pulse Width | Active comparator | This is the Study group. Receives: Device: Fixed Pulse Width |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the first appropriate shock to revert a tachyarrhythmia to sinus rhythm
Rate of rhythm conversion from Ventricular Tachyarrhythmia to sinus rhythm by the first appropriate shock programmed to 25 Joules (or equivalent voltage) programming the shock waveform in Fixed Pulse Width (Study Group) versus the Fixed Tilt with value 65% (Control Group).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start6 Jun 2018
- Primary completion18 Apr 2025
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrythmiaStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 779 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ignacio Fernandez, MD, Principal investigatorJavier Alzueta, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632057
- Sponsor's protocol ID
- CRD_914
- Acronym
- EFICAZ
- Status last verified
- May 2025
- First submitted
- 19 Jul 2018
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shock Efficacy, a Randomized Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population
- ClinicalTrials.gov ID
- NCT03632057
- Acronym / sponsor ID
- EFICAZ / CRD_914
- Conditions
- Ventricular Arrythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 779 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 15 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 is a prospective, 1:1 randomized, interventional, multicenter and international trial. Approximately 790 subjects are expected to be enrolled to 40 sites in the south of Europe and Middle East.
Detailed description
The objective of this study is to evaluate and compare the efficacy of the first appropriate shock of an ICD in a ventricular tachyarrhythmia, when the waveform of the shock is programmed with the standard waveform, Fixed Tilt with a value of 65% (Control Group), versus the exclusive waveform programmable in SJM ICDs, Fixed Pulse Width (Study Group), in a standard population of subjects with ICD indication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed Tilt (65%) | Active comparator | Device: Fixed Tilt (65%)This is the control group, so device programming for shock energy is the default setting |
| Fixed Pulse Width | Active comparator | Device: Fixed Pulse WidthThis is the Study group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who meet the current ESC indications for ICD or CRT-D implant. This includes upgrades indications from pacemaker to ICD or to CRT-D or replacements of ICDs or CRT-Ds provided that there is no previous record of ineffective shocks
Key exclusion criteria (7 listed)
- • Subjects on the waiting list for a heart transplant or under consideration for a transplant over the next 12 months
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 |
|---|---|---|
| Fixed Tilt (65%)This is the standard group, so device programming for shock energy is the default setting | Device | Fixed Tilt (65%) |
| Fixed Pulse WidthThe device has to be programmed with fixed pulse width for each phase of the biphasic waveform | Device | Fixed Pulse Width |
Primary outcome
Efficacy of the first appropriate shock to revert a tachyarrhythmia to sinus rhythm
Time frame: 5 years
Rate of rhythm conversion from Ventricular Tachyarrhythmia to sinus rhythm by the first appropriate shock programmed to 25 Joules (or equivalent voltage) programming the shock waveform in Fixed Pulse Width (Study Group) versus the Fixed Tilt with value 65% (Control Group).
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 7 May 2025.
- Individual participant dataSharing planned: No
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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.
Ignacio Fernandez, MD principal investigator
Javier Alzueta, MD principal investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed Tilt (65%) and Fixed Pulse Width in people with Ventricular Arrythmia, run by Abbott Medical Devices at 2 sites in Spain.
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 7 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 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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. 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?
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?
Efficacy of the first appropriate shock to revert a tachyarrhythmia to sinus rhythm (time frame: 5 years). 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 7 May 2025.