BradycardiaPacingRVNCT02153242
The Effects of Selective Site Right Ventricular Pacing
An observational study of Bradycardia, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a pilot study into the effects on heart function when pacing the right ventricle (RV). This study aims to enrol a population with structurally normal hearts. The investigators aim to measure heart function directly when pacing. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bradycardia
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Jun 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing SVT studies
Who may be able to join
- Patients undergoing elective Electrophysiological Studies +/Ablation
- Age 18-80
- Normal Heart on Pre-procedural Echocardiogram
Who cannot join
- Atrial Fibrillation
- Evidence of anterograde conducting accessory pathway
- Permanent Pacemaker insitu
- Pregnant
- Breast Feeding
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Essex Cardiothoracic Centre
Basildon, Essex, SS16 5NL
About this study
Official title: Does a Surrogate Marker Exist That Can be Used as A Predictor For Left Ventricular Dysfunction In Patients Undergoing Right Ventricular Pacing
This is a pilot study into the effects on heart function when pacing the right ventricle (RV). This study aims to enrol a population with structurally normal hearts. The investigators aim to measure heart function directly when pacing.
When normal conduction within the heart fails, the treatment may be to implant a permanent pacemaker. Pacing involves passing a lead via a vein to the heart and using an electrical impulse to stimulate a beat. The usual site for pacing is the tip of the RV. This has been shown to be less efficient than the normal conduction system of the heart and in some cases leads to markedly reduced function. What the investigators do not know is why this is the case.
Read more
Much effort has been directed at looking at features within the left ventricle (LV) for markers of disease progression but little has been investigated regarding the RV.
There may be some benefit to pacing the heart preferentially from different parts of the RV and the investigators aim to measure if any differences are detectable from stimulating the heart at various sites within the RV.
Read the detailed description
Inclusion Criteria;
- Patients undergoing elective Electrophysiological Studies +/Ablation
- Age 18-80
- Normal Heart on Pre-procedural Echocardiogram
Exclusion criteria;
- Atrial Fibrillation
- Evidence of anterograde conducting accessory pathway
- Permanent Pacemaker insitu
- Pregnant
- Breast Feeding
Outcome Measures; Change in load-independent indices of LV and RV contractility before and after pacing intervention. LV and RV function measured by transthoracic echocardiography and tissue Doppler imaging.
- Conditions
- Bradycardia
- Keywords
- Pacing, Haemodynamics, Pilot
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Supra Ventricular Tachycardia (SVT) | Patients undergoing SVT studies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular Function
Measurement of both right and left ventricular function under differing pacing conditions
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startSep 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart Tan, Principal investigator, Basildon & Thurrock University Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153242
- Sponsor's protocol ID
- B596
- Acronym
- PacingRV
- Status last verified
- Dec 2020
- First submitted
- 6 May 2014
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Surrogate Marker Exist That Can be Used as A Predictor For Left Ventricular Dysfunction In Patients Undergoing Right Ventricular Pacing
- ClinicalTrials.gov ID
- NCT02153242
- Acronym / sponsor ID
- PacingRV / B596
- Conditions
- Bradycardia
- Keywords
- Pacing, Haemodynamics, Pilot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 3 Jun 2014 (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.
This is a pilot study into the effects on heart function when pacing the right ventricle (RV). This study aims to enrol a population with structurally normal hearts. The investigators aim to measure heart function directly when pacing.
When normal conduction within the heart fails, the treatment may be to implant a permanent pacemaker. Pacing involves passing a lead via a vein to the heart and using an electrical impulse to stimulate a beat. The usual site for pacing is the tip of the RV. This has been shown to be less efficient than the normal conduction system of the heart and in some cases leads to markedly reduced function. What the investigators do not know is why this is the case.
Much effort has been directed at looking at features within the left ventricle (LV) for markers of disease progression but little has been investigated regarding the RV.
There may be some benefit to pacing the heart preferentially from different parts of the RV and the investigators aim to measure if any differences are detectable from stimulating the heart at various sites within the RV.
Detailed description
Inclusion Criteria;
- Patients undergoing elective Electrophysiological Studies +/Ablation
- Age 18-80
- Normal Heart on Pre-procedural Echocardiogram
Exclusion criteria;
- Atrial Fibrillation
- Evidence of anterograde conducting accessory pathway
- Permanent Pacemaker insitu
- Pregnant
- Breast Feeding
Outcome Measures; Change in load-independent indices of LV and RV contractility before and after pacing intervention. LV and RV function measured by transthoracic echocardiography and tissue Doppler imaging.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supra Ventricular Tachycardia (SVT) | – | –Patients undergoing SVT studies |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing SVT studies
Key inclusion criteria (3 listed)
- Patients undergoing elective Electrophysiological Studies +/Ablation
- Age 18-80
- Normal Heart on Pre-procedural Echocardiogram
Key exclusion criteria (5 listed)
- Atrial Fibrillation
- Evidence of anterograde conducting accessory pathway
- Permanent Pacemaker insitu
- Pregnant
- Breast Feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ventricular Function
Time frame: 30 minutes
Measurement of both right and left ventricular function under differing pacing conditions
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 22 Dec 2020.
- 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.
Stuart Tan principal investigator
Basildon & Thurrock University Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia, run by Mid and South Essex NHS Foundation 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 3 inclusion and 5 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 22 Dec 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?
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?
Ventricular Function (time frame: 30 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 22 Dec 2020.