Monomorphic Ventricular TachycardiaEPICNCT02584595
Evaluation of Inducible Monomorphic Ventricular Tachycardia (MMVT) in Patients With St. Jude Medical (SJM) Implantable Cardioverter Defibrillator (ICD) Systems or Cardiac Resynchronization Therapy Defibrillation (CRT-D) Systems.
An observational study of Monomorphic Ventricular Tachycardia, run by Abbott Medical Devices.
Trial summary
The intent of this observational study is to understand the role of non-invasive programmed stimulation (NIPS) to induce substrate based MMVT (Monomorphic Ventricular Tachycardia) in patients receiving new St. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Monomorphic Ventricular Tachycardia
- What is being tested?
- ICD/CRT-D with NIPS or EP Study
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Feb 2022
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The primary study population includes patients who meet all inclusion/exclusion criteria, has had or will have market-approved St. Jude Medical ICD or CRT-D device systems implanted, and has no history of MMVT.
Who may be able to join
- Patient is receiving a new SJM ICD or CRT-D implant system, which has study required programing capabilities and is appropriate for remote monitoring. Patients who have received the ICD or CRT-D up to 30 days prior to enrollment are also eligible.
- Patient consents to have a NIPS/EP study.
- Patient has documented Ejection Fraction (EF) < 50% and / or Right Ventricular (RV) dysfunction.
- Patient has documented structural cardiomyopathy of any kind >1 month.
- Patient is between 18 to 75 years of age.
- Patient has been informed of the nature of the study and has agreed to its provisions and provided written informed consent using a form approved by the Institutional Review Board/Ethics Committee (IRB/EC).
Who cannot join
- Patient has history of stroke.
- Patient has had ST Segment elevation myocardial infarction (MI); or previous cardiac surgery within 60 days prior to enrollment.
- Patient is pregnant or nursing.
- Patient has chronic New York Heart Association (NYHA) Class IV heart failure.
- Patient has limited life expectancy according to the investigator (less than one year).
- Patient has had a recent coronary artery bypass graft (CABG) (< 60 days) or percutaneous coronary intervention (PCI) (< 30 days).
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- Patient is currently participating in an investigational drug or device study Patient is unable or unwilling to cooperate with the study procedures.
- Patient has a prosthetic mitral or aortic valve.
- Patient has mitral or aortic valvular heart disease requiring immediate surgical intervention.
- Patient has Left Ventricular EF < 15%.
- Patient has had a previous ablation procedure for ventricular tachycardia (VT), excluding remote (> 3 months) outflow tract tachycardia.
- Patient has previously documented history of severe loss of kidney function or kidney failure.
- Patient has premature ventricular contractions (PVC) or VT induced cardiomyopathy expected to resolve with ablation and will not require an ICD.
- Patient has reversible cause of VT.
About this study
Official title: An Evaluation of Inducible Monomorphic Ventricular Tachycardia (MMVT) in Patients With St. Jude Medical Implantable Cardioverter Defibrillator (ICD) Systems or Cardiac Resynchronization Therapy Defibrillation (CRT-D) Systems.
The intent of this observational study is to understand the role of non-invasive programmed stimulation (NIPS) to induce substrate based MMVT (Monomorphic Ventricular Tachycardia) in patients receiving new St. Jude Medical Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillation (CRT-D) systems.
Read the detailed description
Approximately 50 centers worldwide will participate in the study. Additional centers outside the US may be considered, as necessary. The anticipated enrollment duration is 48-60 months.
This study provides a mechanism for sites to refer subjects for potential enrollment to the Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia (STAR-VT) Investigational Device Exemption (IDE) study (ClinicalTrials.gov NCT02130765).
Patients receiving ICD or CRT-D device implant (or have received it within 30 days) may be enrolled in the study.
- Conditions
- Monomorphic Ventricular Tachycardia
- Being tested
- ICD/CRT-D with NIPS or EP Study
- Keywords
- Tachycardia, Ventricular Tachycardia, Cardiac Arrhythmias, Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Tachycardia, Tachycardia, Ventricular, Arrhythmias, Cardiac, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD/CRT-D with NIPS or EP StudyDevice
ICD/CRT-D implanted patients are tested for inducible MMVT during electrophysiology (EP) Study or Non-Invasive Programmed Stimulation (NIPS) Study
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of ICD/CRT-D implanted patients with documented monomorphic ventricular tachycardia.
Measured: 12 months
Secondary outcomes (2)
Number of ICD shocks.
Measured: 12 months
Quality of Life via Short Form Survey (SF-36)
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 posted22 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2022 (estimated)
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monomorphic Ventricular 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584595
- Sponsor's protocol ID
- SJM-CIP-10068
- Acronym
- EPIC
- Status last verified
- Feb 2019
- First submitted
- 21 Oct 2015
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
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
- An Evaluation of Inducible Monomorphic Ventricular Tachycardia (MMVT) in Patients With St. Jude Medical Implantable Cardioverter Defibrillator (ICD) Systems or Cardiac Resynchronization Therapy Defibrillation (CRT-D) Systems.
- ClinicalTrials.gov ID
- NCT02584595
- Acronym / sponsor ID
- EPIC / SJM-CIP-10068
- Conditions
- Monomorphic Ventricular Tachycardia
- Keywords
- Tachycardia, Ventricular Tachycardia, Cardiac Arrhythmias, Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 22 Oct 2015 (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 intent of this observational study is to understand the role of non-invasive programmed stimulation (NIPS) to induce substrate based MMVT (Monomorphic Ventricular Tachycardia) in patients receiving new St. Jude Medical Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillation (CRT-D) systems.
Detailed description
Approximately 50 centers worldwide will participate in the study. Additional centers outside the US may be considered, as necessary. The anticipated enrollment duration is 48-60 months.
This study provides a mechanism for sites to refer subjects for potential enrollment to the Substrate Targeted Ablation Using the FlexAbility™ Ablation Catheter System for the Reduction of Ventricular Tachycardia (STAR-VT) Investigational Device Exemption (IDE) study (ClinicalTrials.gov NCT02130765).
Patients receiving ICD or CRT-D device implant (or have received it within 30 days) may be enrolled in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The primary study population includes patients who meet all inclusion/exclusion criteria, has had or will have market-approved St. Jude Medical ICD or CRT-D device systems implanted, and has no history of MMVT.
Key inclusion criteria (6 listed)
- Patient is receiving a new SJM ICD or CRT-D implant system, which has study required programing capabilities and is appropriate for remote monitoring. Patients who have received the ICD or CRT-D up to 30 days prior to enrollment are also eligible.
- Patient consents to have a NIPS/EP study.
- Patient has documented Ejection Fraction (EF) < 50% and / or Right Ventricular (RV) dysfunction.
- Patient has documented structural cardiomyopathy of any kind >1 month.
- Patient is between 18 to 75 years of age.
Key exclusion criteria (14 listed)
- Patient has history of stroke.
- Patient has had ST Segment elevation myocardial infarction (MI); or previous cardiac surgery within 60 days prior to enrollment.
- Patient is pregnant or nursing.
- Patient has chronic New York Heart Association (NYHA) Class IV heart failure.
- Patient has limited life expectancy according to the investigator (less than one year).
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/CRT-D with NIPS or EP StudyICD/CRT-D implanted patients are tested for inducible MMVT during electrophysiology (EP) Study or Non-Invasive Programmed Stimulation (NIPS) Study | Device | – |
Primary outcome
Rate of ICD/CRT-D implanted patients with documented monomorphic ventricular tachycardia.
Time frame: 12 months
2 secondary outcomes
Number of ICD shocks.
Time frame: 12 months
Quality of Life via Short Form Survey (SF-36)
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Monomorphic Ventricular Tachycardia, run by Abbott Medical Devices.
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 14 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: withdrawn, 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Rate of ICD/CRT-D implanted patients with documented monomorphic ventricular tachycardia. (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.