Ventricular TachycardiaNCT02844127
Effect of Right Ventricular Lead Position on Defibrillation Threshold
A study testing Implantable Cardioverter Defibrillator (ICD) in people with Ventricular Tachycardia and Ventricular Fibrillation, run by OhioHealth at 1 site in United States.
Trial summary
The purpose of this study is to determine how the position of the right ventricular (RV) coil of an implantable cardioverter defibrillator (apex versus septum) affects the defibrillation threshold; specifically, can defibrillator threshold be improved by implantation site selection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ventricular Fibrillation
- What is being tested?
- Implantable Cardioverter Defibrillator (ICD)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 4 Apr 2017
- 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
- Patient indicates for single-chamber (VR), dual-chamber (DR) or resynchronization CRT-D) implantable defibrillator
- Left-sided implant
- Single coil or dual coil (single coil for testing)
- Age ≥ 18 years of age
- Ability to consent
- Medically stable, in the opinion of the implanting physician, to undergo defibrillation safety margin testing
- Procedure performed under conscious sedation
- English-speaking
Who cannot join
- Patient unable to understand and consent to the procedure on his or her own
- Pregnant or breastfeeding patients
- New York Heart Association (NYHA) Class IV
- Patients with pre-existing RV leads
- Pacemaker dependent
- Patient medically unstable to undergo defibrillation testing (e.g., high risk for deep sedation; patients that develop respiratory compromise or hemodynamic instability from the sedation)
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- Patients that require general anesthesia instead of conscious sedation
- Patients <18 years of age
- Non-English-speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
OhioHealth Grant Medical Center
Columbus, Ohio, 43215
About this study
The purpose of this study is to determine how the position of the right ventricular (RV) coil of an implantable cardioverter defibrillator (apex versus septum) affects the defibrillation threshold; specifically, can defibrillator threshold be improved by implantation site selection.
Read the detailed description
The investigators propose a prospective, pseudo-randomized study of patients who are electing to undergo implantation of an implantable cardioverter defibrillator (ICD).
There are two locations in the heart in which ICDs are normally implanted: the apex and the septum. The purpose of this study is to determine whether the ICD performs better in one location or the other, as measured by defibrillation threshold. In this study, both locations will be tested in each patient. The final location will be determined by the implanting physician as the location that is best for the patient.
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation
- Being tested
- Implantable Cardioverter Defibrillator (ICD)
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Cardioverter Defibrillator (ICD)Procedure or surgery
Patients will receive an Implantable Cardioverter Defibrillator (ICD), with the leads implanted in either the apex or the septum as the first location. After defibrillation threshold is determined, the leads position will be changed to the second location and DFT will be determined again.
| Study group | Role | What they receive |
|---|---|---|
| Apex First | Other | Patients born in odd-numbered years will receive an implantable cardioverter defibrillator (ICD). Defibrillation threshold determined with the right ventricular lead placed first in the apex and then in the septum. Final lead position will be determined at the discretion of the implanting physician. Receives: Procedure: Implantable Cardioverter Defibrillator (ICD) |
| Septum First | Other | Patients born in even-numbered years will receive an implantable cardioverter defibrillator (ICD). Defibrillation threshold determined with the right ventricular lead placed first in the septum and then in the apex. Final lead position will be determined at the discretion of the implanting physician Receives: Procedure: Implantable Cardioverter Defibrillator (ICD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defibrillator threshold
Defibrillator threshold (DFT) will be determined at the time of implantation for each patient at the apex and the septum. A difference of >4 joules will be considered clinically significant.
Measured: At the time of each surgery through study completion, or up to 12 months
Secondary outcomes (1)
Percentage of patients with improved defibrillation threshold at the septum versus the apex
The percentage of patients that have an improved safety profile from septal implantation versus apical implantation will be calculated. Improved safety profile is defined as a defibrillation threshold increase of >4 joules.
Measured: At the time of each surgery through study completion, or up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startNov 2016
- Primary completion4 Apr 2017
- Study completion4 Apr 2017
Why it stopped: Devices proposed for use in the protocol no longer used by physician
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- OhioHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
- Investigators
- Seth J Rials, MD, PhD, Principal investigator, OhioHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844127
- Sponsor's protocol ID
- OhioHealth 16-0029
- Status last verified
- Sep 2017
- First submitted
- 8 Jul 2016
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Because this is a pilot study with limited data collection, data will not need to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Right Ventricular Lead Position on Defibrillation Threshold
- ClinicalTrials.gov ID
- NCT02844127
- Acronym / sponsor ID
- OhioHealth 16-0029
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Devices proposed for use in the protocol no longer used by physician
- Enrolment
- 0 participants (actual)
- Lead sponsor
- OhioHealthUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- Nov 2016
- Primary completion
- 4 Apr 2017 (actual)
- Study completion
- 4 Apr 2017 (actual)
- First posted
- 26 Jul 2016 (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 study is to determine how the position of the right ventricular (RV) coil of an implantable cardioverter defibrillator (apex versus septum) affects the defibrillation threshold; specifically, can defibrillator threshold be improved by implantation site selection.
Detailed description
The investigators propose a prospective, pseudo-randomized study of patients who are electing to undergo implantation of an implantable cardioverter defibrillator (ICD).
There are two locations in the heart in which ICDs are normally implanted: the apex and the septum. The purpose of this study is to determine whether the ICD performs better in one location or the other, as measured by defibrillation threshold. In this study, both locations will be tested in each patient. The final location will be determined by the implanting physician as the location that is best for the patient.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apex First | Other | Procedure: Implantable Cardioverter Defibrillator (ICD)Patients born in odd-numbered years will receive an implantable cardioverter defibrillator (ICD). Defibrillation threshold determined with the right ventricular lead placed first in the apex and then in the septum. Final lead position will be determined at the discretion of the implanting physician. |
| Septum First | Other | Procedure: Implantable Cardioverter Defibrillator (ICD)Patients born in even-numbered years will receive an implantable cardioverter defibrillator (ICD). Defibrillation threshold determined with the right ventricular lead placed first in the septum and then in the apex. Final lead position will be determined at the discretion of the implanting physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient indicates for single-chamber (VR), dual-chamber (DR) or resynchronization CRT-D) implantable defibrillator
- Left-sided implant
- Single coil or dual coil (single coil for testing)
- Age ≥ 18 years of age
- Ability to consent
Key exclusion criteria (9 listed)
- Patient unable to understand and consent to the procedure on his or her own
- Pregnant or breastfeeding patients
- New York Heart Association (NYHA) Class IV
- Patients with pre-existing RV leads
- Pacemaker dependent
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 |
|---|---|---|
| Implantable Cardioverter Defibrillator (ICD)Patients will receive an Implantable Cardioverter Defibrillator (ICD), with the leads implanted in either the apex or the septum as the first location. After defibrillation threshold is determined, the leads position will be changed to the second location and DFT will be determined again. | Procedure or surgery | Apex First, Septum First |
Primary outcome
Defibrillator threshold
Time frame: At the time of each surgery through study completion, or up to 12 months
Defibrillator threshold (DFT) will be determined at the time of implantation for each patient at the apex and the septum. A difference of >4 joules will be considered clinically significant.
1 secondary outcome
Percentage of patients with improved defibrillation threshold at the septum versus the apex
Time frame: At the time of each surgery through study completion, or up to 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 19 Sep 2017.
- Individual participant dataSharing planned: No. Because this is a pilot study with limited data collection, data will not need to be shared.
Related trials for Ventricular Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
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.
Seth J Rials, MD, PhD principal investigator
OhioHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable Cardioverter Defibrillator (ICD) in people with Ventricular Tachycardia and Ventricular Fibrillation, run by OhioHealth at 1 site in United States.
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 8 inclusion and 9 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 19 Sep 2017. 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 United States. 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 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?
Defibrillator threshold (time frame: At the time of each surgery through study completion, or up to 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 19 Sep 2017.