Heart FailureCRT clinicNCT01426321
Combining Myocardial Strain and Cardiac CT to Optimize Left Ventricular Lead Placement in CRT Treatment
A study testing Imaging guided LV lead positioning in people with Heart Failure, run by Region Skane at 1 site in Sweden.
Trial summary
For patients with advanced heart failure, Cardiac Resynchronization Therapy (CRT) has been a major improvement. The treatment improves symptoms and prolongs life in selected patients with heart failure. 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?
- Imaging guided LV lead positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2011to Dec 2018
- 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
- Symptomatic heart failure (New York Heart Association functional class II - IV) despite stabile optimal medical therapy.
- Wide QRS ≥ 120 milliseconds on standard ECG.
- LV systolic dysfunction (EF ≤ 35%).
- Written informed consent.
- Accepted for CRT-P or CRT-D treatment
Who cannot join
- Life expectancy < 12 months.
- Recent myocardial infarction (< 3 months).
- Significant valve disease
- Chronic atrial fibrillation
- Pregnancy
- Severely impaired renal function (estimated glomerular filtration rate (eGFR) < 30 ml/min)
- Unable to give written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individually Tailored Cardiac Resynchronization Therapy - Combing Myocardial Strain and Cardiac CT to Optimize Left Ventricular Lead Placement in Cardiac Resynchronization Therapy
For patients with advanced heart failure, Cardiac Resynchronization Therapy (CRT) has been a major improvement. The treatment improves symptoms and prolongs life in selected patients with heart failure. However, with the current selection criteria and methods for implanting the pacemaker, only 60-70% of the patients derive significant benefit from the treatment.
New imaging techniques, including advanced ultrasound and computed tomography, in combination with new versatile multi-pole electrodes, have made an individually tailored therapy possible. Using these techniques in combination, the study will investigate the effect of individually based "optimal" placement of the pacemaker electrodes vs. standard care. The optimal LV electrode position is defined as pacing a viable segment with the latest mechanical delay, targeting a specific segment of the coronary sinus as visualised on cardiac CT. The hypothesis is that this will increase the number of positive responders from 65% to 85%.
- Conditions
- Heart Failure
- Being tested
- Imaging guided LV lead positioning
- Keywords
- Cardiac resynchronization therapy, Echocardiography, Cardiac computed tomography
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging guided LV lead positioningOther
LV lead positioning guided by echocardiography (mechanical strain evaluation by speckle tracking) in combination with cardiac CT. A viable segment with the latest mechanical activation is targeted, and an appropriate "optimal" cardiac vein segment is then chosen using the CT images.
| Study group | Role | What they receive |
|---|---|---|
| Imaging guided LV lead positioning | Active comparator | Not described Receives: Other: Imaging guided LV lead positioning |
| Standard LV lead positioning | No intervention | The LV lead position is decided at the discretion of the treating physician. Cardiac CT images are available for viewing, but no echocardiography data regarding segmental myocardial strain are available. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive response to CRT treatment
The primary efficacy endpoint will evaluate the effect of echocardiography and cardiac CT guided placement of the left ventricular lead vs standard care (i.e. position of the left ventricular lead at the discretion of the treating physician).
Number of patients with positive response to CRT (YES or NO). A positive response is defined as survival in combination with either a reduction in end systolic left ventricular volume ≥ 15% by echocardiography ("volume responder") and / or improvement ≥ 1 NYHA class and ≥10% improvement in 6 minute hall walk test ("clinical responder").
Measured: 6 months
Secondary outcomes (13)
Response to CRT (on-treatment analysis)
Evaluate the effect of optimal LV placement (post hoc analysis of both groups) versus non-optimal LV lead placement. Optimal lead placement is defined as pacing from a viable segment with the latest mechanical activation (by myocardial strain measurement). Outcome measure is the same as in the primary outcome measure.
Measured: 6 months
Heart failure morbidity
Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to hospitalisation for worsening of heart failure
Measured: 6 months 2 years and 5 years
Morbidity and mortality
Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to a composite endpoint of all cause mortality and hospitalisation for worsening of heart failure (2 years and 5 years).
Measured: 6 months 2 years and 5 years
Mortality
Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to all cause mortality
Measured: 6 months, 2 years and 5 years
Left ventricular dyssynchrony
Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to echocardiography measured changes in LV dyssynchrony
Measured: 6 months
Ventricular tachycardia
Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to number of treated ventricular tachycardia episodes
Measured: 6 months 2 years and 5 years
Quality of life
Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to the change in the Minnesota Living with heart failure Quality of Life questionnaire
Measured: 6 months 2 years 5 years
Myocardial viability
Evaluate the concordance in viability assessment using myocardial strain evaluation (echocardiography) compared to cardiac MRI.
Measured: Peroperative
Biochemical markers of heart failure
Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to the change in blood natriuretic peptide (BNP) levels
Measured: 6 months
Left ventricular systolic function
Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to the change in LV ejection fraction
Measured: 6 months
Myocardial viability
Evaluate the concordance between echocardiography (strain evaluation with speckle tracking) and cardiac MRI viability images (late gadolinium enhancement).
Measured: 6 months
MRI left ventricular dyssynchrony
Evaluate if MRI dyssynchroni evaluation has incremental value over echocardiography alone for predicting the effect of cardiac resynchronization therapy.
Measured: 6 months
Left ventricular diastolic dimension
Evaluate the effect of echocardiography guided LV lead placement compared to standard care in relation to the change in left ventricular diastolic dimension
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJan 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Crafoord Foundation
- Responsible party
- Sponsor
- Investigators
- Rasmus Borgquist, MD PhD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426321
- Sponsor's protocol ID
- CRTCLIN01
- Acronym
- CRT clinic
- Status last verified
- Mar 2019
- First submitted
- 25 Aug 2011
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Borgquist R, Carlsson M, Markstad H, Werther-Evaldsson A, Ostenfeld E, Roijer A, Bakos Z. Cardiac Resynchronization Therapy Guided by Echocardiography, MRI, and CT Imaging: A Randomized Controlled Study. JACC Clin Electrophysiol. 2020 Oct;6(10):1300-1309. doi: 10.1016/j.jacep.2020.05.011. Epub 2020 Aug 12.
PubMed 33092758
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individually Tailored Cardiac Resynchronization Therapy - Combing Myocardial Strain and Cardiac CT to Optimize Left Ventricular Lead Placement in Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT01426321
- Acronym / sponsor ID
- CRT clinic / CRTCLIN01
- Conditions
- Heart Failure
- Keywords
- Cardiac resynchronization therapy, Echocardiography, Cardiac computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Crafoord Foundation
- Study start
- Aug 2011 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 31 Aug 2011 (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.
For patients with advanced heart failure, Cardiac Resynchronization Therapy (CRT) has been a major improvement. The treatment improves symptoms and prolongs life in selected patients with heart failure. However, with the current selection criteria and methods for implanting the pacemaker, only 60-70% of the patients derive significant benefit from the treatment.
New imaging techniques, including advanced ultrasound and computed tomography, in combination with new versatile multi-pole electrodes, have made an individually tailored therapy possible. Using these techniques in combination, the study will investigate the effect of individually based "optimal" placement of the pacemaker electrodes vs. standard care. The optimal LV electrode position is defined as pacing a viable segment with the latest mechanical delay, targeting a specific segment of the coronary sinus as visualised on cardiac CT. The hypothesis is that this will increase the number of positive responders from 65% to 85%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imaging guided LV lead positioning | Active comparator | Other: Imaging guided LV lead positioning |
| Standard LV lead positioning | No intervention | –The LV lead position is decided at the discretion of the treating physician. Cardiac CT images are available for viewing, but no echocardiography data regarding segmental myocardial strain are available. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Symptomatic heart failure (New York Heart Association functional class II - IV) despite stabile optimal medical therapy.
- Wide QRS ≥ 120 milliseconds on standard ECG.
- LV systolic dysfunction (EF ≤ 35%).
- Written informed consent.
- Accepted for CRT-P or CRT-D treatment
Key exclusion criteria (7 listed)
- Life expectancy < 12 months.
- Recent myocardial infarction (< 3 months).
- Significant valve disease
- Chronic atrial fibrillation
- Pregnancy
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 |
|---|---|---|
| Imaging guided LV lead positioningLV lead positioning guided by echocardiography (mechanical strain evaluation by speckle tracking) in combination with cardiac CT. A viable segment with the latest mechanical activation is targeted, and an appropriate "optimal" cardiac vein segment is then chosen using the CT images. | Other | Imaging guided LV lead positioning |
Primary outcome
Positive response to CRT treatment
Time frame: 6 months
The primary efficacy endpoint will evaluate the effect of echocardiography and cardiac CT guided placement of the left ventricular lead vs standard care (i.e. position of the left ventricular lead at the discretion of the treating physician). Number of patients with positive response to CRT (YES or NO). A positive response is defined as survival in combination with either a reduction in end systolic left ventricular volume ≥ 15% by echocardiography ("volume responder") and / or improvement ≥ 1 NYHA class and ≥10% improvement in 6 minute hall walk test ("clinical responder").
13 secondary outcomes
Response to CRT (on-treatment analysis)
Time frame: 6 months
Heart failure morbidity
Time frame: 6 months 2 years and 5 years
Morbidity and mortality
Time frame: 6 months 2 years and 5 years
Mortality
Time frame: 6 months, 2 years and 5 years
Left ventricular dyssynchrony
Time frame: 6 months
Ventricular tachycardia
Time frame: 6 months 2 years and 5 years
Quality of life
Time frame: 6 months 2 years 5 years
Myocardial viability
Time frame: Peroperative
Biochemical markers of heart failure
Time frame: 6 months
Left ventricular systolic function
Time frame: 6 months
Myocardial viability
Time frame: 6 months
MRI left ventricular dyssynchrony
Time frame: 6 months
Left ventricular diastolic dimension
Time frame: 6 months
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 Mar 2019.
- Derived from this study: PubMed 33092758Borgquist R, Carlsson M, Markstad H, Werther-Evaldsson A, Ostenfeld E, Roijer A, Bakos Z. Cardiac Resynchronization Therapy Guided by Echocardiography, MRI, and CT Imaging: A Randomized Controlled Study. JACC Clin Electrophysiol. 2020 Oct;6(10):1300-1309. doi: 10.1016/j.jacep.2020.05.011. Epub 2020 Aug 12.
Related trials for Heart Failure
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
RecruitingObservational study
dPmax for Predicting Right Ventricular Failure After Left Ventricular Assist Device Implantation
Ventricular Dysfunction, Right
Active, not recruiting
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial
Aortic Valve Stenosis, Regurgitation, Aortic
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
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.
Rasmus Borgquist, MD PhD principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging guided LV lead positioning in people with Heart Failure, run by Region Skane at 1 site in Sweden.
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 5 inclusion and 7 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 Mar 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 Sweden. 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?
Positive response to CRT treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01426321, which also lists 1 linked publication.
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 Mar 2019.