Heart FailureNCT04322877
Cardiac Resynchronisation Therapy In Patients With Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping
A study testing Temporary pacing Study, Thoracic CT and Acute hemodynamic study in people with Heart Failure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Cardiac Resynchronisation Therapy (CRT) is a specialist pacemaker procedure that aims to improve the efficiency of the heartbeat. This treatment is used routinely in patients with heart failure and a delay in electrical conduction across the heart seen on the surface ECG (heart tracing). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Temporary pacing Study, Thoracic CT and Acute hemodynamic study
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2019to 30 Sep 2021
- 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
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Either 1) has CRT system in situ or 2) has a planned CRT system implant or 3) has a planned upgrade to CRT from a standard pacemaker
- NYHA grade II-IV heart failure
- LVEF<35%
- Intrinsic QRS duration >120ms
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- On optimum medical therapy for heart failure
- Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
- Able (in the Investigators opinion) and willing to comply with all study requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Who cannot join
- Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
- Scheduled elective surgery or other procedures requiring general anaesthesia during the study.
- Participant who is terminally ill or is inappropriate for placebo medication
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Rate uncontrolled atrial fibrillation precluding a cMR
- Significant peripheral vascular disease precluding an EP study
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- A contraindication to anticoagulation
- A prosthetic aortic or tricuspid valve
- Significant Aortic valve disease
- Known LV thrombus
- Insufficient capacity to consent to the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Guys and St Thomas' NHS Foundation Trust
London, SE1 7EH
Christopher A Rinaldi, 02071889257, aldo.rinaldi@kcl.ac.uk
About this study
Cardiac Resynchronisation Therapy (CRT) is a specialist pacemaker procedure that aims to improve the efficiency of the heartbeat. This treatment is used routinely in patients with heart failure and a delay in electrical conduction across the heart seen on the surface ECG (heart tracing). The investigators aim to assess acute response to CRT and compare different methods of delivering CRT using hemodynamic data from invasive dP/dTmax and electroanatomical data from either invasive mapping or non-invasive body surface mapping.
- Conditions
- Heart Failure
- Being tested
- Temporary pacing Study, Thoracic CT, Acute hemodynamic study, Non-invasive body surface mapping, Invasive catheter-based mapping
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary pacing StudyProcedure or surgery
Also called Electrophysiology study
Temporary delivery of CRT
Thoracic CTRadiation
As part of non-invasive mapping protocol
Acute hemodynamic studyDiagnostic test
Measurement of invasive dP/dTmax
Non-invasive body surface mappingDiagnostic test
Cardioinsight body surface mapping
Invasive catheter-based mappingDiagnostic test
Invasive electroanatomical mapping
| Study group | Role | What they receive |
|---|---|---|
| Body surface mapping and temporary pacing | Experimental | Temporary pacing procedure with acute hemodynamic study and non-invasive body surface mapping. Receives: Procedure: Temporary pacing Study; Radiation: Thoracic CT; Diagnostic Test: Acute hemodynamic study; Diagnostic Test: Non-invasive body surface mapping |
| Catheter-based mapping and temporary pacing | Experimental | Temporary pacing procedure with acute hemodynamic study and invasive catheter-based mapping. Receives: Procedure: Temporary pacing Study; Diagnostic Test: Acute hemodynamic study; Diagnostic Test: Invasive catheter-based mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in LV dP/dTmax >10 percent during temporary multisite pacing
Measured: Intra-procedure
Secondary outcomes (1)
Electrical dyssynchrony measured from electro-anatomical mapping
Measured: Intra-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Sep 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322877
- Sponsor's protocol ID
- 125230
- Status last verified
- Mar 2020
- First submitted
- 24 Mar 2020
- Last updated
- 30 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Resynchronisation Therapy In Patients With Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping
- ClinicalTrials.gov ID
- NCT04322877
- Acronym / sponsor ID
- 125230
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 26 Mar 2020 (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 Resynchronisation Therapy (CRT) is a specialist pacemaker procedure that aims to improve the efficiency of the heartbeat. This treatment is used routinely in patients with heart failure and a delay in electrical conduction across the heart seen on the surface ECG (heart tracing). The investigators aim to assess acute response to CRT and compare different methods of delivering CRT using hemodynamic data from invasive dP/dTmax and electroanatomical data from either invasive mapping or non-invasive body surface mapping.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body surface mapping and temporary pacing | Experimental | Procedure: Temporary pacing Study, Radiation: Thoracic CT, Diagnostic Test: Acute hemodynamic study, Diagnostic Test: Non-invasive body surface mappingTemporary pacing procedure with acute hemodynamic study and non-invasive body surface mapping. |
| Catheter-based mapping and temporary pacing | Experimental | Procedure: Temporary pacing Study, Diagnostic Test: Acute hemodynamic study, Diagnostic Test: Invasive catheter-based mappingTemporary pacing procedure with acute hemodynamic study and invasive catheter-based mapping. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Either 1) has CRT system in situ or 2) has a planned CRT system implant or 3) has a planned upgrade to CRT from a standard pacemaker
- NYHA grade II-IV heart failure
- LVEF<35%
Key exclusion criteria (11 listed)
- Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
- Scheduled elective surgery or other procedures requiring general anaesthesia during the study.
- Participant who is terminally ill or is inappropriate for placebo medication
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Rate uncontrolled atrial fibrillation precluding a cMR
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 |
|---|---|---|
| Temporary pacing StudyAlso: Electrophysiology studyTemporary delivery of CRT | Procedure or surgery | Body surface mapping and temporary pacing, Catheter-based mapping and temporary pacing |
| Thoracic CTAs part of non-invasive mapping protocol | Radiation | Body surface mapping and temporary pacing |
| Acute hemodynamic studyMeasurement of invasive dP/dTmax | Diagnostic test | Body surface mapping and temporary pacing, Catheter-based mapping and temporary pacing |
| Non-invasive body surface mappingCardioinsight body surface mapping | Diagnostic test | Body surface mapping and temporary pacing |
| Invasive catheter-based mappingInvasive electroanatomical mapping | Diagnostic test | Catheter-based mapping and temporary pacing |
Primary outcome
Improvement in LV dP/dTmax >10 percent during temporary multisite pacing
Time frame: Intra-procedure
1 secondary outcome
Electrical dyssynchrony measured from electro-anatomical mapping
Time frame: Intra-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary pacing Study, Thoracic CT and Acute hemodynamic study in people with Heart Failure, run by Guy's and St Thomas' 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 10 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 30 Mar 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 Christopher A Rinaldi, MBBS MD FHRS (02071889257, aldo.rinaldi@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in LV dP/dTmax >10 percent during temporary multisite pacing (time frame: Intra-procedure). 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 30 Mar 2020.