ArrhythmiasHIPACENCT02629445
HIPACE High Frequency Low Energy Pacing to Terminate Fast Ventricular Arrythmias
A study testing Cardiac Resynchronisation Defibrillator in people with Arrhythmias, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
People that have survived, or are at high risk of a lifethreatening ventricular arrhythmia are routinely offered a defibrillator (ICD). An ICD is an implanted device which can recognise a ventricular arrhythmia and then try to treat it, either by rapidly pacing the heart or by shocking the heart. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Arrhythmias
- What is being tested?
- Cardiac Resynchronisation Defibrillator
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2015to 29 Jul 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is older than 18 years of age; Any patient with a Medtronic cardiac implantable defibrillator undergoing defibrillation testing; No contra indication to defibrillation testing Patient is able to give informed consent.
Who cannot join
- Patient is younger than 18 years; Patient is not able to give informed consent or is unwilling to participate in the study; Patient has a contraindication to defibrillation testing
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS2 9LN
About this study
Official title: High Frequency Low Energy Pacing to Terminate Fast Ventricular Arrythmias
People that have survived, or are at high risk of a lifethreatening ventricular arrhythmia are routinely offered a defibrillator (ICD). An ICD is an implanted device which can recognise a ventricular arrhythmia and then try to treat it, either by rapidly pacing the heart or by shocking the heart. Currently, very fast ventricular arrhythmias, known as VF, can only be treated with a shock. Patients find shocks painful and this study is intended to find out whether it is possible to pace the heart at very high rates during VF. It is hoped that if this is possible, further research could lead to effective treatment of VF with pacing rather than shocks, and therefore better outcomes for patients.
- Conditions
- Arrhythmias
- Being tested
- Cardiac Resynchronisation Defibrillator
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronisation DefibrillatorDevice
Defibrillation testing of cardiac defibrilator
What is being measured
The primary outcome is the main question the study is designed to answer.
Rapid pacing of the heart
The primary outcome measure is to determine whether it is possible to obtain ventricular capture of the heart by repetitive pacing at very high rates during ventricular fibrillation.
Measured: 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study startNov 2015
- Primary completion29 Jul 2016
- Study completion29 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiasStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
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
- NCT02629445
- Sponsor's protocol ID
- CD14/11241
- Acronym
- HIPACE
- Status last verified
- Feb 2019
- First submitted
- 10 Dec 2015
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Frequency Low Energy Pacing to Terminate Fast Ventricular Arrythmias
- ClinicalTrials.gov ID
- NCT02629445
- Acronym / sponsor ID
- HIPACE / CD14/11241
- Conditions
- Arrhythmias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- 29 Jul 2016 (actual)
- Study completion
- 29 Jul 2016 (actual)
- First posted
- 14 Dec 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.
People that have survived, or are at high risk of a lifethreatening ventricular arrhythmia are routinely offered a defibrillator (ICD). An ICD is an implanted device which can recognise a ventricular arrhythmia and then try to treat it, either by rapidly pacing the heart or by shocking the heart. Currently, very fast ventricular arrhythmias, known as VF, can only be treated with a shock. Patients find shocks painful and this study is intended to find out whether it is possible to pace the heart at very high rates during VF. It is hoped that if this is possible, further research could lead to effective treatment of VF with pacing rather than shocks, and therefore better outcomes for patients.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient is older than 18 years of age; Any patient with a Medtronic cardiac implantable defibrillator undergoing defibrillation testing; No contra indication to defibrillation testing Patient is able to give informed consent.
Key exclusion criteria (1 listed)
- Patient is younger than 18 years; Patient is not able to give informed consent or is unwilling to participate in the study; Patient has a contraindication to defibrillation testing
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 |
|---|---|---|
| Cardiac Resynchronisation DefibrillatorDefibrillation testing of cardiac defibrilator | Device | – |
Primary outcome
Rapid pacing of the heart
Time frame: 10 seconds
The primary outcome measure is to determine whether it is possible to obtain ventricular capture of the heart by repetitive pacing at very high rates during ventricular fibrillation.
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 28 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Resynchronisation Defibrillator in people with Arrhythmias, 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: finished, as of the sponsor's last update on 28 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 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?
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?
Rapid pacing of the heart (time frame: 10 seconds). 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 28 Feb 2019.