Heart FailureENDO-CRTNCT02174289
LV Endocardial Cardiac Resynchronisation Therapy
A study testing Targeted left ventricular endocardial lead placement in people with Heart Failure, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Cardiac resynchronisation therapy (CRT) is an established treatment for severe systolic heart failure with well documented benefits in symptom improvement and reduction of morbidity and mortality. However, upto 30% of patients do not respond to treatment despite fulfilling the recommended indications. 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?
- Targeted left ventricular endocardial lead placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2014to Apr 2017
- 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
- Age greater than 18 years
- NYHA class II-IV
- LVEF ≤35%
- QRS ≥120 milliseconds
- Optimal tolerated medical therapy
- Either unable to position an LV lead via the standard coronary sinus on CRT implantation
- OR Recipient of a CRT-P or CRT-D system for greater than 6 months for standard indications AND limited improvement or worsened clinical status despite device optimisation
- Informed consent
Who cannot join
- Life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders
- Previous atrial septal defect device closure.
- Chronic renal dialysis and End stage liver disease
- History of stroke, myocardial infarction, unstable angina, Coronary artery bypass grafting and coronary stenting within the last 3 months
- Presence of correctable valvular disease (aortic/mitral)
- Mitral valve prosthesis.
Show all 9Show fewer
- Contra indication to vitamin K antagonist
- Unresolved intra-cardiac thrombus
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Charles Butcher, MBBS MRCP contact
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Brompton and Harefield NHS Foundation Trust
London
Charles Butcher, MBBS MRCP, c.butcher@rbht.nhs.uk
Tom Wong
About this study
Official title: A Randomised Double-blinded Cross Over Study to Evaluate the Improvement of Left Ventricular Systolic Failure Using Targeted Left Ventricular Endocardial Lead Placement in Cardiac Resynchronisation Therapy.
Cardiac resynchronisation therapy (CRT) is an established treatment for severe systolic heart failure with well documented benefits in symptom improvement and reduction of morbidity and mortality. However, upto 30% of patients do not respond to treatment despite fulfilling the recommended indications. Lack of clinical response may be the result of imperfect left ventricular lead placement in the veins around the heart with conventional techniques. Optimum lead placement may constrained by coronary venous anatomy and may overlie scarred heart muscle or may not be at the site of latest electrical depolarisation. In a further 10% of patients, conventional left ventricular lead placement is not possible for other technical reasons.
Left ventricular endocardial lead placement may overcome the limitations and allow placement to be guided by echocardiography, electrical mapping and the pattern of heart muscle scarring.
Read more
We aim to investigate if targeted left ventricular endocardial lead placement improves exercise capacity, heart failure symptoms, heart function and size, heart pumping efficiency and biochemical markers of heart strain. Each parameter will be assessed independently and as part of a composite cardiac performance score.
Patients with heart failure will be enrolled who require an endocardial left ventricular lead on clinical grounds as either conventional left ventricular lead implantation has technically failed or they have clinically non-responded to CRT.
- Conditions
- Heart Failure
- Being tested
- Targeted left ventricular endocardial lead placement
- Keywords
- Heart Failure, Cardiac Resynchronisation Therapy, Transseptal left ventricular endocardial lead
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted left ventricular endocardial lead placementDevice
The left ventricular endocardial lead will be passed through the intra-atrial septum
| Study group | Role | What they receive |
|---|---|---|
| Active Bi-ventricular Pacing | Active comparator | Not described Receives: Device: Targeted left ventricular endocardial lead placement |
| No Biventricular pacing | Placebo comparator | Not described Receives: Device: Targeted left ventricular endocardial lead placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary Exercise Test
Improvement in peak oxygen consumption
Measured: 3 months
Secondary outcomes (7)
New NYHA Class
Change in New York Heart Association functional Class
Measured: 3 months
6 minute walk
Change in 6 minute hall walk test distance
Measured: 3 months
Quality of life
Minnesota Living with heart failure questionnaire score
Measured: 3 months
Echocardiography
Change in size and function of the heart
Measured: 3 months
Digital photoplethysmography
Cardiac output
Measured: 3 months
Biochemical response
Change in eGFR (estimated glomerular filtration rate) and NT pro BNP (N terminal pro brain natriuretic peptide) levels.
Measured: 3 months
Composite cardiac assessment score
Change in composite assessment score made up of symptom, exercise tolerance, echocardiographic and biochemical parameters.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tom Wong, MD FESC, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174289
- Sponsor's protocol ID
- 2013PS003H
- Other IDs
- ISROTH20092
- Acronym
- ENDO-CRT
- Status last verified
- Jun 2014
- First submitted
- 24 Jun 2014
- Last updated
- 27 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005 Apr 14;352(15):1539-49. doi: 10.1056/NEJMoa050496. Epub 2005 Mar 7.
PubMed 15753115McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. No abstract available.
PubMed 22611136Gras D, Bocker D, Lunati M, Wellens HJ, Calvert M, Freemantle N, Gervais R, Kappenberger L, Tavazzi L, Erdmann E, Cleland JG, Daubert JC; CARE-HF Study Steering Committee and Investigators. Implantation of cardiac resynchronization therapy systems in the CARE-HF trial: procedural success rate and safety. Europace. 2007 Jul;9(7):516-22. doi: 10.1093/europace/eum080. Epub 2007 May 31.
PubMed 17540662Jais P, Douard H, Shah DC, Barold S, Barat JL, Clementy J. Endocardial biventricular pacing. Pacing Clin Electrophysiol. 1998 Nov;21(11 Pt 1):2128-31. doi: 10.1111/j.1540-8159.1998.tb01133.x.
PubMed 9826866van Gelder BM, Scheffer MG, Meijer A, Bracke FA. Transseptal endocardial left ventricular pacing: an alternative technique for coronary sinus lead placement in cardiac resynchronization therapy. Heart Rhythm. 2007 Apr;4(4):454-60. doi: 10.1016/j.hrthm.2006.11.023. Epub 2006 Nov 29.
PubMed 17399634Nuta B, Lines I, MacIntyre I, Haywood GA. Biventricular ICD implant using endocardial LV lead placement from the left subclavian vein approach and transseptal puncture via the transfemoral route. Europace. 2007 Nov;9(11):1038-40. doi: 10.1093/europace/eum176. Epub 2007 Aug 17.
PubMed 17704095Jais P, Takahashi A, Garrigue S, Yamane T, Hocini M, Shah DC, Barold SS, Deisenhofer I, Haissaguerre M, Clementy J. Mid-term follow-up of endocardial biventricular pacing. Pacing Clin Electrophysiol. 2000 Nov;23(11 Pt 2):1744-7. doi: 10.1111/j.1540-8159.2000.tb07010.x.
PubMed 11139915Spragg DD, Dong J, Fetics BJ, Helm R, Marine JE, Cheng A, Henrikson CA, Kass DA, Berger RD. Optimal left ventricular endocardial pacing sites for cardiac resynchronization therapy in patients with ischemic cardiomyopathy. J Am Coll Cardiol. 2010 Aug 31;56(10):774-81. doi: 10.1016/j.jacc.2010.06.014.
PubMed 20797490Khan FZ, Virdee MS, Palmer CR, Pugh PJ, O'Halloran D, Elsik M, Read PA, Begley D, Fynn SP, Dutka DP. Targeted left ventricular lead placement to guide cardiac resynchronization therapy: the TARGET study: a randomized, controlled trial. J Am Coll Cardiol. 2012 Apr 24;59(17):1509-18. doi: 10.1016/j.jacc.2011.12.030. Epub 2012 Mar 7.
PubMed 22405632Saba S, Marek J, Schwartzman D, Jain S, Adelstein E, White P, Oyenuga OA, Onishi T, Soman P, Gorcsan J 3rd. Echocardiography-guided left ventricular lead placement for cardiac resynchronization therapy: results of the Speckle Tracking Assisted Resynchronization Therapy for Electrode Region trial. Circ Heart Fail. 2013 May;6(3):427-34. doi: 10.1161/CIRCHEARTFAILURE.112.000078. Epub 2013 Mar 8.
PubMed 23476053
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double-blinded Cross Over Study to Evaluate the Improvement of Left Ventricular Systolic Failure Using Targeted Left Ventricular Endocardial Lead Placement in Cardiac Resynchronisation Therapy.
- ClinicalTrials.gov ID
- NCT02174289
- Acronym / sponsor ID
- ENDO-CRT / 2013PS003H
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Cardiac Resynchronisation Therapy, Transseptal left ventricular endocardial lead
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2017 (estimated)
- First posted
- 25 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.
Cardiac resynchronisation therapy (CRT) is an established treatment for severe systolic heart failure with well documented benefits in symptom improvement and reduction of morbidity and mortality. However, upto 30% of patients do not respond to treatment despite fulfilling the recommended indications. Lack of clinical response may be the result of imperfect left ventricular lead placement in the veins around the heart with conventional techniques. Optimum lead placement may constrained by coronary venous anatomy and may overlie scarred heart muscle or may not be at the site of latest electrical depolarisation. In a further 10% of patients, conventional left ventricular lead placement is not possible for other technical reasons.
Left ventricular endocardial lead placement may overcome the limitations and allow placement to be guided by echocardiography, electrical mapping and the pattern of heart muscle scarring.
We aim to investigate if targeted left ventricular endocardial lead placement improves exercise capacity, heart failure symptoms, heart function and size, heart pumping efficiency and biochemical markers of heart strain. Each parameter will be assessed independently and as part of a composite cardiac performance score.
Patients with heart failure will be enrolled who require an endocardial left ventricular lead on clinical grounds as either conventional left ventricular lead implantation has technically failed or they have clinically non-responded to CRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Bi-ventricular Pacing | Active comparator | Device: Targeted left ventricular endocardial lead placement |
| No Biventricular pacing | Placebo comparator | Device: Targeted left ventricular endocardial lead placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age greater than 18 years
- NYHA class II-IV
- LVEF ≤35%
- QRS ≥120 milliseconds
- Optimal tolerated medical therapy
Key exclusion criteria (9 listed)
- Life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders
- Previous atrial septal defect device closure.
- Chronic renal dialysis and End stage liver disease
- History of stroke, myocardial infarction, unstable angina, Coronary artery bypass grafting and coronary stenting within the last 3 months
- Presence of correctable valvular disease (aortic/mitral)
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 |
|---|---|---|
| Targeted left ventricular endocardial lead placementThe left ventricular endocardial lead will be passed through the intra-atrial septum | Device | Active Bi-ventricular Pacing, No Biventricular pacing |
Primary outcome
Cardiopulmonary Exercise Test
Time frame: 3 months
Improvement in peak oxygen consumption
7 secondary outcomes
New NYHA Class
Time frame: 3 months
6 minute walk
Time frame: 3 months
Quality of life
Time frame: 3 months
Echocardiography
Time frame: 3 months
Digital photoplethysmography
Time frame: 3 months
Biochemical response
Time frame: 3 months
Composite cardiac assessment score
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
- Background: PubMed 15753115Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005 Apr 14;352(15):1539-49. doi: 10.1056/NEJMoa050496. Epub 2005 Mar 7.
- Background: PubMed 22611136McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. No abstract available.
- Background: PubMed 17540662Gras D, Bocker D, Lunati M, Wellens HJ, Calvert M, Freemantle N, Gervais R, Kappenberger L, Tavazzi L, Erdmann E, Cleland JG, Daubert JC; CARE-HF Study Steering Committee and Investigators. Implantation of cardiac resynchronization therapy systems in the CARE-HF trial: procedural success rate and safety. Europace. 2007 Jul;9(7):516-22. doi: 10.1093/europace/eum080. Epub 2007 May 31.
- Background: PubMed 9826866Jais P, Douard H, Shah DC, Barold S, Barat JL, Clementy J. Endocardial biventricular pacing. Pacing Clin Electrophysiol. 1998 Nov;21(11 Pt 1):2128-31. doi: 10.1111/j.1540-8159.1998.tb01133.x.
- Background: PubMed 17399634van Gelder BM, Scheffer MG, Meijer A, Bracke FA. Transseptal endocardial left ventricular pacing: an alternative technique for coronary sinus lead placement in cardiac resynchronization therapy. Heart Rhythm. 2007 Apr;4(4):454-60. doi: 10.1016/j.hrthm.2006.11.023. Epub 2006 Nov 29.
- Background: PubMed 17704095Nuta B, Lines I, MacIntyre I, Haywood GA. Biventricular ICD implant using endocardial LV lead placement from the left subclavian vein approach and transseptal puncture via the transfemoral route. Europace. 2007 Nov;9(11):1038-40. doi: 10.1093/europace/eum176. Epub 2007 Aug 17.
- Background: PubMed 11139915Jais P, Takahashi A, Garrigue S, Yamane T, Hocini M, Shah DC, Barold SS, Deisenhofer I, Haissaguerre M, Clementy J. Mid-term follow-up of endocardial biventricular pacing. Pacing Clin Electrophysiol. 2000 Nov;23(11 Pt 2):1744-7. doi: 10.1111/j.1540-8159.2000.tb07010.x.
- Background: PubMed 20797490Spragg DD, Dong J, Fetics BJ, Helm R, Marine JE, Cheng A, Henrikson CA, Kass DA, Berger RD. Optimal left ventricular endocardial pacing sites for cardiac resynchronization therapy in patients with ischemic cardiomyopathy. J Am Coll Cardiol. 2010 Aug 31;56(10):774-81. doi: 10.1016/j.jacc.2010.06.014.
- Background: PubMed 22405632Khan FZ, Virdee MS, Palmer CR, Pugh PJ, O'Halloran D, Elsik M, Read PA, Begley D, Fynn SP, Dutka DP. Targeted left ventricular lead placement to guide cardiac resynchronization therapy: the TARGET study: a randomized, controlled trial. J Am Coll Cardiol. 2012 Apr 24;59(17):1509-18. doi: 10.1016/j.jacc.2011.12.030. Epub 2012 Mar 7.
- Background: PubMed 23476053Saba S, Marek J, Schwartzman D, Jain S, Adelstein E, White P, Oyenuga OA, Onishi T, Soman P, Gorcsan J 3rd. Echocardiography-guided left ventricular lead placement for cardiac resynchronization therapy: results of the Speckle Tracking Assisted Resynchronization Therapy for Electrode Region trial. Circ Heart Fail. 2013 May;6(3):427-34. doi: 10.1161/CIRCHEARTFAILURE.112.000078. Epub 2013 Mar 8.
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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.
Charles Butcher, MBBS MRCP contact
Tom Wong, MD FESC principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted left ventricular endocardial lead placement in people with Heart Failure, run by Royal Brompton & Harefield 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 8 inclusion and 9 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 27 Jun 2014. 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. Some participants in this study may receive a placebo. 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 Charles Butcher, MBBS MRCP (c.butcher@rbht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary Exercise Test (time frame: 3 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 NCT02174289, which also lists 10 linked publications.
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 27 Jun 2014.