TachycardiaReduceITNCT01963286
Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators
A study testing ICD with enhanced SVT discriminators in people with Tachycardia, run by Abbott Medical Devices at 23 sites in 2 countries.
Trial summary
The purpose of this clinical investigation is the continued assessment of the decision accuracy of St. Jude Medical (SJM) ICD with enhanced SVT discriminators in the treatment of subjects with primary and secondary prevention of sudden cardiac death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia
- What is being tested?
- ICD with enhanced SVT discriminators
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 735 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Aug 2013to Oct 2016
- 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
- Ischemic or nonischemic cardiomyopathy
- Primary prevention or secondary prevention of Sudden cardiac death (SCD)
- Indication for ICD/CRT-D new implantation per current guidelines (1, 2, 3-chamber)
- The patient is ≥ 18 years of age
- The patient is able to understand the patient information and is capable to provide informed consent.
- The patient has provided written informed consent prior to any investigational related procedure
Who cannot join
- Previously implanted ICD/CRT-D
- Hypertrophic (with or without obstructive) cardiomyopathy
- Ion channel disorders (Long/Short-QT, Brugada syndrome etc…)
- New York Heart Association (NYHA) Class IV
- Recent cardiac decompensation (within previous 3 months)
- The patient is unable to comply with the follow up schedule.
- The patient is participating in another investigational device or drug investigation.
- The patient is pregnant or is planning to become pregnant during the duration of the investigation
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
Germany21 sites
Praxis Dr. med. Bernhardt
Annaberg-Buchholz, 09456
Zentralklinik Bad Berka GmbH
Bad Berka, 99438
Hufeland Klinikum GmbH
Bad Langensalza, 99947
Caritas Krankenhaus
Bad Mergentheim
Medizinisches Versorgungszentrum am Küchwald GmbH
Chemnitz, 09113
Praxis Dr. med. Stellmach
Chemnitz, 09126
Klinikum Coburg GmbH
Coburg
Evangelisches Krankenhaus Kalk gGmbH
Cologne
Klinikum Esslingen
Esslingen am Neckar
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Freiburg im Breisgau
Medizinische Hochschule Hannover
Hanover
Oberhavel Kliniken GmbH Klinik Hennigsdorf
Hennigsdorf
Evangelisches Krankenhaus Holzminden gGmbH
Holzminden, 37603
Praxis Frau Dr. med. Gärtner
Leisnig
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen
Klinikum Memmingen
Memmingen
Universitätsklinikum Münster
Münster
Klinikum Oldenburg gGmbH
Oldenburg, 26133
Christliches Krankenhaus Quakenbrück gGmbH
Quakenbrück
Gem.-Praxis Dres. med. Ebert / Stenzel
Riesa
Hegau-Bodensee-Klinikum mbH
Singen
Estonia2 sites
North Estonia Medical Centre
Tallinn
Tartu University Hospital
Tartu
About this study
The purpose of this clinical investigation is the continued assessment of the decision accuracy of St. Jude Medical (SJM) ICD with enhanced SVT discriminators in the treatment of subjects with primary and secondary prevention of sudden cardiac death.
Read the detailed description
With Ellipse™ and Fortify Assura™ ICD family, St. Jude Medical introduced enhanced device algorithms that may be helpful to further improve SVT discrimination success: SecureSense™, Far field morphology, Chamber Onset. These algorithms in combination with a tailored device setting (primary or secondary prevention) will be prospectively investigated within this trial.
- Conditions
- Tachycardia
- Being tested
- ICD with enhanced SVT discriminators
- Keywords
- ICD, CRT-D, Sudden cardiac death, Device settings, Optimized programming strategy
- Medical subject headings
- Tachycardia, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD with enhanced SVT discriminatorsDevice
Also called Ellipse (St. Jude Medical), Fortify Assura (St. Jude Medical), Unify Assura (St. Jude Medical)
ICD will be programmed to uniform device settings with enhanced SVT discrimintators enabled.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced SVT discriminators | Other | Patients with activated enhanced SVT discriminators (in accordance with predefined mandatory study settings) Receives: Device: ICD with enhanced SVT discriminators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inappropriate ICD shocks
Freedom from inappropriate automatically delivered ICD-shocks within 12 months Follow-Up (FU) period after ICD/CRT-D implantation
Measured: 12 months
Secondary outcomes (8)
ICD shocks for any reason
Freedom from automatically delivered ICD shocks for any reason during FU period
Measured: 12 months
Inappropriate ICD therapies
Freedom from automatically delivered inappropriate ICD therapies during FU period
Measured: 12 months
Untreated VT/VF
Freedom from untreated sustained ventricular tachycardia (VT) / ventricular fibrillation (VF) during FU period
Measured: 12 months
Accuracy of ICD therapy decision
Accuracy of ICD therapy decision (VT/VF and nonVT/VF)
Measured: 12 months
Specificity
Specificity for…
- … other than sustained VT/VF
- … SVT (Supraventricular tachycardia)
- … different subtypes of SVTs (Sinus Tachycardia, Atrial Fibrillation, Atrial Flutter, other SVT).
Measured: 12 months
Cardiac deaths
Cardiac deaths
Measured: 12 months
Sensitivity
Sensitivity for sustained VT/VF
Measured: 12 months
ICD/CRT-D related SAE
ICD/CRT-D related Serious Adverse Events (SAE)
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 posted16 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TachycardiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 735 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johann C Geller, Prof. Dr., Study chair, Zentralklinik Bad Berka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963286
- Sponsor's protocol ID
- CR-12-092-GE-HV
- Acronym
- ReduceIT
- Status last verified
- Jan 2019
- First submitted
- 12 Sep 2013
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators
- ClinicalTrials.gov ID
- NCT01963286
- Acronym / sponsor ID
- ReduceIT / CR-12-092-GE-HV
- Conditions
- Tachycardia
- Keywords
- ICD, CRT-D, Sudden cardiac death, Device settings, Optimized programming strategy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 735 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 16 Oct 2013 (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 purpose of this clinical investigation is the continued assessment of the decision accuracy of St. Jude Medical (SJM) ICD with enhanced SVT discriminators in the treatment of subjects with primary and secondary prevention of sudden cardiac death.
Detailed description
With Ellipse™ and Fortify Assura™ ICD family, St. Jude Medical introduced enhanced device algorithms that may be helpful to further improve SVT discrimination success: SecureSense™, Far field morphology, Chamber Onset. These algorithms in combination with a tailored device setting (primary or secondary prevention) will be prospectively investigated within this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enhanced SVT discriminators | Other | Device: ICD with enhanced SVT discriminatorsPatients with activated enhanced SVT discriminators (in accordance with predefined mandatory study settings) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ischemic or nonischemic cardiomyopathy
- Primary prevention or secondary prevention of Sudden cardiac death (SCD)
- Indication for ICD/CRT-D new implantation per current guidelines (1, 2, 3-chamber)
- The patient is ≥ 18 years of age
- The patient is able to understand the patient information and is capable to provide informed consent.
Key exclusion criteria (8 listed)
- Previously implanted ICD/CRT-D
- Hypertrophic (with or without obstructive) cardiomyopathy
- Ion channel disorders (Long/Short-QT, Brugada syndrome etc…)
- New York Heart Association (NYHA) Class IV
- Recent cardiac decompensation (within previous 3 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 |
|---|---|---|
| ICD with enhanced SVT discriminatorsAlso: Ellipse (St. Jude Medical), Fortify Assura (St. Jude Medical), Unify Assura (St. Jude Medical)ICD will be programmed to uniform device settings with enhanced SVT discrimintators enabled. | Device | Enhanced SVT discriminators |
Primary outcome
Inappropriate ICD shocks
Time frame: 12 months
Freedom from inappropriate automatically delivered ICD-shocks within 12 months Follow-Up (FU) period after ICD/CRT-D implantation
8 secondary outcomes
ICD shocks for any reason
Time frame: 12 months
Inappropriate ICD therapies
Time frame: 12 months
Untreated VT/VF
Time frame: 12 months
Accuracy of ICD therapy decision
Time frame: 12 months
Specificity
Time frame: 12 months
Cardiac deaths
Time frame: 12 months
Sensitivity
Time frame: 12 months
ICD/CRT-D related SAE
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 4 Feb 2019.
Related trials for Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruiting
HEAL-IST IDE Trial
Inappropriate Sinus Tachycardia
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
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.
Johann C Geller, Prof. Dr. study chair
Zentralklinik Bad Berka
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICD with enhanced SVT discriminators in people with Tachycardia, run by Abbott Medical Devices at 23 sites in 2 countries.
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 6 inclusion and 8 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Germany, Estonia. 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?
Inappropriate ICD shocks (time frame: 12 months). 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 4 Feb 2019.