ArrythmiaREVRAMPNCT03412240
Reverse RAMP Pacing to Terminate Ventricular Tachycardia ( REV-RAMP)
A study testing Induced pacing of the heart in people with Arrythmia, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Cardiac pacing which involved stimulating the heart electrically with electrical wires that go into the heart is routine practice in the diagnosis and treatment of heart rhythm problems. Clinically this involved the fields of cardiac pacing and electrophysiology. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Arrythmia
- What is being tested?
- Induced pacing of the heart
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Dec 2017to 10 Mar 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who are due to have a new defibrillator (including cardiac resynchronisation defibrillator) implant or box change
Who cannot join
- Contraindications to defibrillator testing e.g. severe untreatable coronary disease Intracardiac thrombus Interruption of anticoagulation Participants undergoing box change, device upgrade or revision Inability or unwillingness to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds
Muzahir Tayebjee, MBChB (Hons) MD MRCP
About this study
Cardiac pacing which involved stimulating the heart electrically with electrical wires that go into the heart is routine practice in the diagnosis and treatment of heart rhythm problems. Clinically this involved the fields of cardiac pacing and electrophysiology. Patients who are at risk of sudden death because of serious heart rhythms that are a result of malfunction of the electrical system of the pumping chambers of the heart (ventricles) are generally implanted with specialised pacemakers that can defibrillate (shock) the heart if a nasty life threatening rhythm should result. Shocks are painful and in order to try and treat these rhythms without shocks, anti tachycardia pacing is performed (this is routine part of the device), which aims to interrupt the rhythm by stimulating the heart electrically. This does not always work and can destabilise the rhythm leading to a shock. REVRAMP is a novel modification of anti tachycardia pacing which involved stimulating the heart through the defibrillator wires in a different way. It appears to work better and seems less likely to destabilise the heart rhythm, hence can reduce painful shocks.
Read the detailed description
Cardiac pacing which involved stimulating the heart electrically with electrical wires that go into the heart is routine practice in the diagnosis and treatment of heart rhythm problems. Clinically this involved the fields of cardiac pacing and electrophysiology. Patients who are at risk of sudden death because of serious heart rhythms that are a result of malfunction of the electrical system of the pumping chambers of the heart (ventricles) are generally implanted with specialised pacemakers that can defibrillate (shock) the heart if a nasty life threatening rhythm should result. Shocks are painful and in order to try and treat these rhythms without shocks, anti tachycardia pacing is performed (this is routine part of the device), which aims to interrupt the rhythm by stimulating the heart electrically. This does not always work and can destabilise the rhythm leading to a shock. REVRAMP is a novel modification of anti tachycardia pacing which involved stimulating the heart through the defibrillator wires in a different way. It appears to work better and seems less likely to destabilise the heart rhythm, hence can reduce painful shocks.
- Conditions
- Arrythmia
- Being tested
- Induced pacing of the heart
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induced pacing of the heartProcedure or surgery
Once the defibrillator leads have been inserted or, in the case of a box change, the old leads have been tested as per routine procedure, these pacing leads will be connected to an external pacing stimulator. The test involves electrically pacing your heart at different rates and we will be constantly monitoring you under close clinical supervision. During the test, your heart will be electrically stimulated to beat at a faster rate.
| Study group | Role | What they receive |
|---|---|---|
| Anti tachycardia pacing | Experimental | Not described Receives: Procedure: Induced pacing of the heart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Termination/cessation of ventricular tachycardia by rev ramp pacing protocol
Measured: 10 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start14 Dec 2017
- Primary completion10 Mar 2020 (estimated)
- Study completion10 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrythmiaStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412240
- Sponsor's protocol ID
- CD16/90568
- Acronym
- REVRAMP
- Status last verified
- Feb 2020
- First submitted
- 19 Jan 2018
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reverse RAMP Pacing to Terminate Ventricular Tachycardia ( REV-RAMP)
- ClinicalTrials.gov ID
- NCT03412240
- Acronym / sponsor ID
- REVRAMP / CD16/90568
- Conditions
- Arrythmia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 10 Mar 2020 (estimated)
- Study completion
- 10 Mar 2020 (estimated)
- First posted
- 26 Jan 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.
Cardiac pacing which involved stimulating the heart electrically with electrical wires that go into the heart is routine practice in the diagnosis and treatment of heart rhythm problems. Clinically this involved the fields of cardiac pacing and electrophysiology. Patients who are at risk of sudden death because of serious heart rhythms that are a result of malfunction of the electrical system of the pumping chambers of the heart (ventricles) are generally implanted with specialised pacemakers that can defibrillate (shock) the heart if a nasty life threatening rhythm should result. Shocks are painful and in order to try and treat these rhythms without shocks, anti tachycardia pacing is performed (this is routine part of the device), which aims to interrupt the rhythm by stimulating the heart electrically. This does not always work and can destabilise the rhythm leading to a shock. REVRAMP is a novel modification of anti tachycardia pacing which involved stimulating the heart through the defibrillator wires in a different way. It appears to work better and seems less likely to destabilise the heart rhythm, hence can reduce painful shocks.
Detailed description
Cardiac pacing which involved stimulating the heart electrically with electrical wires that go into the heart is routine practice in the diagnosis and treatment of heart rhythm problems. Clinically this involved the fields of cardiac pacing and electrophysiology. Patients who are at risk of sudden death because of serious heart rhythms that are a result of malfunction of the electrical system of the pumping chambers of the heart (ventricles) are generally implanted with specialised pacemakers that can defibrillate (shock) the heart if a nasty life threatening rhythm should result. Shocks are painful and in order to try and treat these rhythms without shocks, anti tachycardia pacing is performed (this is routine part of the device), which aims to interrupt the rhythm by stimulating the heart electrically. This does not always work and can destabilise the rhythm leading to a shock. REVRAMP is a novel modification of anti tachycardia pacing which involved stimulating the heart through the defibrillator wires in a different way. It appears to work better and seems less likely to destabilise the heart rhythm, hence can reduce painful shocks.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti tachycardia pacing | Experimental | Procedure: Induced pacing of the heart |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants who are due to have a new defibrillator (including cardiac resynchronisation defibrillator) implant or box change
Key exclusion criteria (1 listed)
- Contraindications to defibrillator testing e.g. severe untreatable coronary disease Intracardiac thrombus Interruption of anticoagulation Participants undergoing box change, device upgrade or revision Inability or unwillingness to provide informed consent.
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 |
|---|---|---|
| Induced pacing of the heartOnce the defibrillator leads have been inserted or, in the case of a box change, the old leads have been tested as per routine procedure, these pacing leads will be connected to an external pacing stimulator. The test involves electrically pacing your heart at different rates and we will be constantly monitoring you under close clinical supervision. During the test, your heart will be electrically stimulated to beat at a faster rate. | Procedure or surgery | Anti tachycardia pacing |
Primary outcome
Termination/cessation of ventricular tachycardia by rev ramp pacing protocol
Time frame: 10 mins
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induced pacing of the heart in people with Arrythmia, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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 19 Feb 2020. 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 Kingdom. 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 Muzahir Tayebjee, MBChB (Hons) MD MRCP (+441133926619, muzahir.tayebjee@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Termination/cessation of ventricular tachycardia by rev ramp pacing protocol (time frame: 10 mins). 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 Feb 2020.