Cardiac ElectrophysiologyNCT03628911
Study to Evaluate Tetanizing Burst Therapy in Patients Undergoing ICD Replacement
A study testing Tetanizing Burst Therapy in people with Cardiac Electrophysiology, run by EP Sciences at 1 site in United States.
Trial summary
This study evaluates whether the addition of tetanizing burst therapy reduces the pain associated with ICD shocks Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Electrophysiology
- What is being tested?
- Tetanizing Burst Therapy
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 1 Dec 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female age 18-80 years, inclusive
- Ability to understand and provide written informed consent
- Normal sinus rhythm
- Standard transvenous left-sided ICD referred for device replacement due to end of battery life
Who cannot join
- Heart rate <40 or >90 bpm
- Atrial fibrillation or pacemaker dependent
- NYHA Class III/IV symptoms of HF
- MI within 90 days of enrollment
- Severe cardiac ischemia manifested by chest pain at rest or with minimal exercise
- History stroke or TIAs
Show all 11Show fewer
- History of prior ICD pocket infection
- ICD lead resistance that is too high or too low in the opinion of the investigator
- Female who is pregnant or breastfeeding
- Prior heart transplant
- Serum electrolytes out of normal range at participating institution
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Michele Martucci, RN, 410-502-0517, mmill148@jhmi.edu
Kathy Avara, 410-502-5616, kavara1@jhmi.edu
About this study
Official title: Evaluation of the Ongoing Safety and Preliminary Efficacy of the Tetanizing Burst Therapy (TBT) System in Subjects Undergoing ICD Replacement Due to End-of-battery Life
This study evaluates whether the addition of tetanizing burst therapy reduces the pain associated with ICD shocks
Read the detailed description
The implantable cardioverter defibrillator is a device designed to rescue patients from life-threatening arrhythmias by delivering a defibrillation shock to allow restoration of cardiac rhythm. These defibrillation shocks are extremely painful, owing to sudden rapid contraction of thoracic and abdominal skeletal muscle, which, in addition to the heart, are stimulated by the defibrillation shock. Tetanizing Burst Therapy is a novel electrical waveform which tetanizes skeletal muscle with a brief burst of stimulation prior to the ICD shock, thereby reducing muscular contraction due to the shock. This study is designed for those patients who are already undergoing ICD replacement.
- Conditions
- Cardiac Electrophysiology
- Being tested
- Tetanizing Burst Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanizing Burst TherapyDevice
Tetanizing Burst Therapy tetanizes skeletal muscle with a brief burst of stimulation prior to ICD shock, thereby reducing muscular contraction due to the shock
What is being measured
The primary outcome is the main question the study is designed to answer.
Less pain after TBT impulse with ICD shock compared to ICD shock alone
Each subject will receive 2 therapies in random order delivered 5 minutes apart:
- Tetanizing Burst Therapy + shock; and
- Pure shock alone. Using the Numeric Pain Rating Scale (NRS) after each shock, the subject will be asked to provide a verbal score between 1 and 10, where 1 is no pain and 10 is the worst pain imaginable.
Measured: 5 minutes
Secondary outcomes (3)
The efficacy of tetanizing burst therapy in subjects undergoing ICD replacement as assessed by NRS verbal score
After each shock, a blinded assessor will ask the subject to provide an NRS verbal score between 1 and 10, where 1 is no pain and 10 is the worst pain imaginable. The percent change in the NRS score will be calculated for each subject along with the change in skeletal muscle force waveform
Measured: 5 minutes
The safety of tetanizing burst therapy in subjects undergoing ICD replacement as assessed by adverse events
Incidence rates of all adverse events will be calculated and compared to event rates in the literature. They will also be analyzed by severity and relationship to the device and/or study procedures.
Measured: 7 days
The device performance of tetanizing burst therapy in subjects undergoing ICD replacement as assessed degree of muscle contraction (Rate of Force Development)
The force of contraction is recorded at the patient's left elbow with a myometer
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 Jan 2018
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ElectrophysiologyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EP Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald Berger, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628911
- Sponsor's protocol ID
- TBT001
- Status last verified
- Sep 2019
- First submitted
- 31 Jul 2018
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ongoing Safety and Preliminary Efficacy of the Tetanizing Burst Therapy (TBT) System in Subjects Undergoing ICD Replacement Due to End-of-battery Life
- ClinicalTrials.gov ID
- NCT03628911
- Acronym / sponsor ID
- TBT001
- Conditions
- Cardiac Electrophysiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- EP SciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 14 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 study evaluates whether the addition of tetanizing burst therapy reduces the pain associated with ICD shocks
Detailed description
The implantable cardioverter defibrillator is a device designed to rescue patients from life-threatening arrhythmias by delivering a defibrillation shock to allow restoration of cardiac rhythm. These defibrillation shocks are extremely painful, owing to sudden rapid contraction of thoracic and abdominal skeletal muscle, which, in addition to the heart, are stimulated by the defibrillation shock. Tetanizing Burst Therapy is a novel electrical waveform which tetanizes skeletal muscle with a brief burst of stimulation prior to the ICD shock, thereby reducing muscular contraction due to the shock. This study is designed for those patients who are already undergoing ICD replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or Female age 18-80 years, inclusive
- Ability to understand and provide written informed consent
- Normal sinus rhythm
- Standard transvenous left-sided ICD referred for device replacement due to end of battery life
Key exclusion criteria (11 listed)
- Heart rate <40 or >90 bpm
- Atrial fibrillation or pacemaker dependent
- NYHA Class III/IV symptoms of HF
- MI within 90 days of enrollment
- Severe cardiac ischemia manifested by chest pain at rest or with minimal exercise
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 |
|---|---|---|
| Tetanizing Burst TherapyTetanizing Burst Therapy tetanizes skeletal muscle with a brief burst of stimulation prior to ICD shock, thereby reducing muscular contraction due to the shock | Device | – |
Primary outcome
Less pain after TBT impulse with ICD shock compared to ICD shock alone
Time frame: 5 minutes
Each subject will receive 2 therapies in random order delivered 5 minutes apart: * Tetanizing Burst Therapy + shock; and * Pure shock alone. Using the Numeric Pain Rating Scale (NRS) after each shock, the subject will be asked to provide a verbal score between 1 and 10, where 1 is no pain and 10 is the worst pain imaginable.
3 secondary outcomes
The efficacy of tetanizing burst therapy in subjects undergoing ICD replacement as assessed by NRS verbal score
Time frame: 5 minutes
The safety of tetanizing burst therapy in subjects undergoing ICD replacement as assessed by adverse events
Time frame: 7 days
The device performance of tetanizing burst therapy in subjects undergoing ICD replacement as assessed degree of muscle contraction (Rate of Force Development)
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- 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.
Ronald Berger, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetanizing Burst Therapy in people with Cardiac Electrophysiology, run by EP Sciences 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 17 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jane Wilson (8457218210, janew@databean.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Less pain after TBT impulse with ICD shock compared to ICD shock alone (time frame: 5 minutes). 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 17 Sep 2019.