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出境医 / 临床实验 / A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy (TACTIC CRT)
A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy (TACTIC CRT)
Study Description
Brief Summary:
The purpose of the study is to determine whether MRI guided CRT implantation (using Siemen's software prototype) is superior to standard treatment in terms of CRT response. Data will be collected at enrolment, implant, pre-discharge, 6 weeks and 6 months. The total duration of the investigation will be 6 months.
The primary endpoint will be assessed by calculating the difference in the proportion of responders (>15% reduction in end systolic volume derived from 2-dimensional transthoracic echocardiogram at 6 months post CRT implant).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiovascular Diseases | Device: Guide CRT Software Prototype | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 218 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Care Provider) |
| Primary Purpose: | Treatment |
| Official Title: | A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy |
| Actual Study Start Date : | July 5, 2019 |
| Estimated Primary Completion Date : | July 5, 2021 |
| Estimated Study Completion Date : | July 5, 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
| No Intervention: Standard CRT implantation | |
| Experimental: MRI guided CRT implantation |
Device: Guide CRT Software Prototype
The medical device in the trial is a software programme that allows image fusion of previously acquired MRI images with real-time X-Ray fluoroscopic images in the cardiac catheter laboratory. We are able to use the MRI information to assess the best location to place the left ventricular lead for a CRT device and then superimpose this location onto the real-time X-Ray fluoroscopic images during the left ventricular lead implantation
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Outcome Measures
Primary Outcome Measures :
- >15% reduction in end systolic volume [ Time Frame: 6 months ]>15% reduction in end systolic volume derived from 2-dimensional transthoracic echocardiogram at 6 months post CRT implant
Secondary Outcome Measures :
- 5% absolute increase in left ventricular ejection fraction [ Time Frame: 6 months ]5% absolute increase in left ventricular ejection fraction as derived from 2D echocardiogram
- >10% reduction in end diastolic volume [ Time Frame: 6 months ]>10% reduction in end diastolic volume as derived from 2D echocardiogram
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- >18yrs of age
- Standard indication for CRT-P or CRT-D according to European Society of Cardiology (ESC)/European Heart Rhythm (EHRA) guidelines.1
- Stable on optimal medical therapy for at least 3 months
- Ischaemic aetiology
- Patients with atrial fibrillation can be included
Exclusion Criteria:
- Any contraindication to pacing /implantable cardioverter-defibrillator (ICD) implant
- Requirement for endocardial pacing
- Contraindication to gadolinium contrast enhanced cardiac Magnetic Resonance (MR) scanning
- Significant claustrophobia
- Significant renal impairment with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
- Existing pacemaker or ICD system or extraction of a CRT system within the last 6 months
- Participation in other studies with active treatment/ investigational arm
- Pregnant or planning to become pregnant in the next 7 months
Contacts and Locations
Locations
| United Kingdom | |
| Guys and St Thomas NHS Foundation Trust | Recruiting |
| London, United Kingdom, SE1 7EH | |
| Contact: Humra Chadwick 02071887188 ext 56217 humra.chadwick1@gstt.nhs.uk | |
| Principal Investigator: Aldo Rinaldi | |
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
King's College London
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 18, 2019 | ||||
| First Posted Date ICMJE | June 20, 2019 | ||||
| Last Update Posted Date | March 5, 2020 | ||||
| Actual Study Start Date ICMJE | July 5, 2019 | ||||
| Estimated Primary Completion Date | July 5, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
>15% reduction in end systolic volume [ Time Frame: 6 months ] >15% reduction in end systolic volume derived from 2-dimensional transthoracic echocardiogram at 6 months post CRT implant
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy | ||||
| Official Title ICMJE | A Prospective Randomised Multi-centre Trial Comparing cArdiac MRI Guided CRT Versus Conventional CRT Implantation in Patients With Ischaemic Cardiomyopathy | ||||
| Brief Summary |
The purpose of the study is to determine whether MRI guided CRT implantation (using Siemen's software prototype) is superior to standard treatment in terms of CRT response. Data will be collected at enrolment, implant, pre-discharge, 6 weeks and 6 months. The total duration of the investigation will be 6 months. The primary endpoint will be assessed by calculating the difference in the proportion of responders (>15% reduction in end systolic volume derived from 2-dimensional transthoracic echocardiogram at 6 months post CRT implant). |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Care Provider) Primary Purpose: Treatment |
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| Condition ICMJE | Cardiovascular Diseases | ||||
| Intervention ICMJE | Device: Guide CRT Software Prototype
The medical device in the trial is a software programme that allows image fusion of previously acquired MRI images with real-time X-Ray fluoroscopic images in the cardiac catheter laboratory. We are able to use the MRI information to assess the best location to place the left ventricular lead for a CRT device and then superimpose this location onto the real-time X-Ray fluoroscopic images during the left ventricular lead implantation
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
218 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | July 5, 2022 | ||||
| Estimated Primary Completion Date | July 5, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | |||||
| Listed Location Countries ICMJE | United Kingdom | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03992560 | ||||
| Other Study ID Numbers ICMJE | 1.1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Guy's and St Thomas' NHS Foundation Trust | ||||
| Study Sponsor ICMJE | Guy's and St Thomas' NHS Foundation Trust | ||||
| Collaborators ICMJE | King's College London | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Guy's and St Thomas' NHS Foundation Trust | ||||
| Verification Date | June 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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