Heart FailureTRIUMPH-CRTNCT02350842
Triple-site Biventricular Stimulation in the Optimization of CRT
A study testing triple-site biventricular pacing with peri-operative echo guidance and standard biventricular pacing in people with Heart Failure, run by MicroPort CRM at 14 sites in 6 countries.
Trial summary
Cardiac resynchronization is a recommended therapy for patients with advanced heart failure, under optimized medical treatment with reduced left ventricular ejection fraction and prolonged QRS, nevertheless, still 30% of the population do not respond to standard biventricular implantation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- triple-site biventricular pacing with peri-operative echo guidance and standard biventricular pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 14 sitesin 6 countries
- Study dates
- Jul 2015to 25 Apr 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Stable heart failure with New York Heart Association (NYHA) functional class II, III or ambulatory IV
- Stable optimized medical regimen according to medical guidelines (No change in heart failure medication for at least 1 month prior to enrollment)
- Left ventricular ejection fraction (LVEF) ≤ 35%
- Intrinsic QRS duration ≥ 140 msec
- Non-typical left bundle branch block (LBBB) morphology on 12-lead surface ECG
- Signed and dated informed consent
Who cannot join
- Typical LBBB according to Strauss criteria
- Unstable heart failure
- Permanent or long-lasting persistent Atrial Fibrillation
- Unstable angina, acute Myocardial Infarction (MI), Coronary Artery Bypass-Grafting (CABG), or Percutaneous Transluminal Coronary Angioplasty (PTCA) within 90 days prior to enrollment (intervention)
- Conventional pacemaker indication
- Previous implant with a pacemaker or an Implantable Cardioverter-Defibrillator (ICD)
Show all 13Show fewer
- Renal Failure (Glomerular filtration rate (GFR) < 30 ml/min/1.73m2)
- Pregnant women
- Already included in another clinical study that could confound the results of this study
- Life expectancy < 12 months
- Mechanical heart valve or indication for valve repair or replacement
- Recent Cerebro-Vascular Accident (CVA) or Transient Ischemic Attack (TIA) (within the previous 3 months)
- Heart transplant
Trial locations and contacts
14 sites in 6 countries.
14 sites in 6 countries
France8 sites
CHRU Hopital Sud
Amiens, 80054
Clinique Rhone Durance
Avignon, 84082
Hopital Jean Minjoz Besançon
Besançon, 25030
CHRU Brest
Brest, 29609
Groupe hospitalier Paris Saint-Joseph
Paris, 75614
CHU Poitiers
Poitiers, 86021
CHU Hôpital Charles Nicolle
Rouen, 76031
CHU Toulouse, Hopital Rangueil
Toulouse, 31400
Spain2 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, 8025
Hospital Universitario La Fe
Valencia, 46009
About this study
Official title: Triple-site Biventricular Stimulation in the Optimization of Cardiac Resynchronization Therapy (CRT)
Cardiac resynchronization is a recommended therapy for patients with advanced heart failure, under optimized medical treatment with reduced left ventricular ejection fraction and prolonged QRS, nevertheless, still 30% of the population do not respond to standard biventricular implantation.
Non-response can be explained by a combination of factors including sub-optimal patient selection, placement of the pacing lead over a zone of slow conduction, insufficient correction of mechanical dyssynchrony including sub-optimal lead implantation. Few data distinguish true non-responders from patients in which effective resynchronization was not delivered through standard biventricular implantation.
Triple-site cardiac resynchronization pacing (stimulation at three ventricular sites) has been proposed to improve synchrony and thus the response rate in (Cardiac Resynchronisation Therapy) CRT recipients.
Read the detailed description
The frequent failure of CRT in non-Left Bundle Branch Block (non-LBBB) patients is suspected to be due to more complex and heterogeneous forms of electrical/mechanical dyssynchronies needing more complex and individualized pacing configurations to be corrected.
Acute studies during implant show that standard biventricular pacing provides optimal mechanical improvement only in a minority of patients. In a peri-operative echo-guided leads placement procedure most of non-improved patients could be successfully mechanically resynchronized. A significant number of patients required optimized placement of right ventricular (RV) lead and/or triple-site configurations.
These studies led to the hypothesis that more complex and individualized pacing configurations (Triple-site biventricular) might increase the number of responders to CRT.
To assess this hypothesis, this study will be conducted in Class II-ambulatory IV patients indicated for CRT with wide QRS (≥ 140 ms) and non-LBBB. Patients will be randomized in a 1:1 configuration:
- Standard biventricular pacing (1 right ventricular/1 left ventricular (1RV/1LV)) through classical implantation procedure without peri-operative optimization
- Triple-site biventricular pacing with individual optimization of the placement of the third lead by peri-operative echo guidance.
The objective of the optimization process is to improve LV efficiency and to decrease the left pre-ejection interval (LPEI, defined as the time interval between the onset of QRS and the onset of LV ejection) as much as possible compared with a standard biventricular configuration by moving a second right ventricular lead at different locations.
LPEI is simple to measure, with good inter- and intra-observer reproducibility and its utility has previously been strongly suggested.
Reduction in LPEI results in decreased duration of ventricular systole and is associated with improved LV filling and reduced interventricular delay.
The primary objective of this study is to demonstrate that individually optimized, triple-site biventricular pacing is superior to standard biventricular pacing in reverse ventricular modeling as demonstrated by Echo Left Ventricle End-Systolic Volume (LVESV) at 1 year in patients with non-LBBB morphology without increasing the risk of serious procedure and/or device related adverse events at 30 days.
- Conditions
- Heart Failure
- Being tested
- triple-site biventricular pacing with peri-operative echo guidance, standard biventricular pacing
- Keywords
- non-Left Bundle Branch Block morphology, Triple-site biventricular pacing, cardiac resynchronization therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triple-site biventricular pacing with peri-operative echo guidanceDevice
placement of the third lead by peri-operative echo guidance.
standard biventricular pacingDevice
standard biventricular pacing without optimization by echo guidance
| Study group | Role | What they receive |
|---|---|---|
| Triple-site biventricular pacing | Experimental | Triple-site biventricular pacing with individual optimization of the placement of the third lead by peri-operative echo guidance. Devices used will be the Sorin, locally approved and commercially available Paradym SonR Tri-V CRT-D. Receives: Device: triple-site biventricular pacing with peri-operative echo guidance |
| Standard biventricular pacing | Active comparator | Standard biventricular pacing (1RV/1LV) through classical implantation procedure without peri-operative optimization. Devices used will be locally approved and commercially available Sorin implantable cardioverter defibrillators. Receives: Device: standard biventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
TriV pacing is superior to standard BiV pacing in reversing ventricular modeling as demonstrated by Echo LVESV at 12 months in pts. with non LBBB without increasing the risk of serious events at 30 days.
The efficacy endpoint for this study is the change in LVESV at twelve months post-implant between individually optimized, triple-site biventricular pacing and standard biventricular pacing.
LVESV is a standard marker of CRT effectiveness1. Echocardiographic data collected at twelve months follow-up will document the evolution of LVESV as compared to baseline in order to assess reverse ventricular remodeling.
The safety endpoint for this study is the rate of all serious procedure and/or device related events reported at thirty days post-implant.
Measured: 12 months
Secondary outcomes (4)
Evaluate serious device related complications at six and twelve months post-procedure.
A safety assessment will be performed, including all reported events collected for all enrolled patients.
Measured: 6 and 12 months
Evaluate reverse ventricular remodeling response based on additional echocardiographic measures
Change in LV volumes and LV ejection fraction will be evaluated as part of reverse remodeling response, based on echocardiographic measurements:
- LVESV at 6 months
- LVEDV at 6 and 12 months
- LVEF at 6 and 12 months
Measured: 6 and 12 months
Evaluate patient's clinical status considering New York Heart Association (NYHA) functional class improvement
A patient's clinical status will be evaluated considering:
- NYHA functional class improvement - The evaluation of the NYHA classification consists of reporting the percentage of patients who improved at least one NYHA class at each follow-up post-implant.
- Death from any cause - The reporting of deaths occurred consists of the percentage of dead patients, the causes of death, the time to death and survival curves.
- HF-related hospitalizations, as defined in section 15.4.
- The incidence of serious device related events assessed at six and twelve months.
Measured: 6 and 12 months
Evaluate mortality and serious heart failure (HF) events during the procedure through discharge and at the different follow-up time-points.
A safety assessment will be performed, including all reported events collected for all enrolled patients.
Measured: 1, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startJul 2015
- Primary completion31 Mar 2017
- Study completion25 Apr 2018
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.
- 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort CRM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Claude Daubert, MD, Principal investigator, Hôpital Pontchaillou-CHU Rennes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350842
- Sponsor's protocol ID
- ICSY02
- Acronym
- TRIUMPH-CRT
- Status last verified
- Mar 2019
- First submitted
- 20 Jan 2015
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple-site Biventricular Stimulation in the Optimization of Cardiac Resynchronization Therapy (CRT)
- ClinicalTrials.gov ID
- NCT02350842
- Acronym / sponsor ID
- TRIUMPH-CRT / ICSY02
- Conditions
- Heart Failure
- Keywords
- non-Left Bundle Branch Block morphology, Triple-site biventricular pacing, cardiac resynchronization therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- MicroPort CRMIndustry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 25 Apr 2018 (actual)
- First posted
- 30 Jan 2015 (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 resynchronization is a recommended therapy for patients with advanced heart failure, under optimized medical treatment with reduced left ventricular ejection fraction and prolonged QRS, nevertheless, still 30% of the population do not respond to standard biventricular implantation.
Non-response can be explained by a combination of factors including sub-optimal patient selection, placement of the pacing lead over a zone of slow conduction, insufficient correction of mechanical dyssynchrony including sub-optimal lead implantation. Few data distinguish true non-responders from patients in which effective resynchronization was not delivered through standard biventricular implantation.
Triple-site cardiac resynchronization pacing (stimulation at three ventricular sites) has been proposed to improve synchrony and thus the response rate in (Cardiac Resynchronisation Therapy) CRT recipients.
Detailed description
The frequent failure of CRT in non-Left Bundle Branch Block (non-LBBB) patients is suspected to be due to more complex and heterogeneous forms of electrical/mechanical dyssynchronies needing more complex and individualized pacing configurations to be corrected.
Acute studies during implant show that standard biventricular pacing provides optimal mechanical improvement only in a minority of patients. In a peri-operative echo-guided leads placement procedure most of non-improved patients could be successfully mechanically resynchronized. A significant number of patients required optimized placement of right ventricular (RV) lead and/or triple-site configurations.
These studies led to the hypothesis that more complex and individualized pacing configurations (Triple-site biventricular) might increase the number of responders to CRT.
To assess this hypothesis, this study will be conducted in Class II-ambulatory IV patients indicated for CRT with wide QRS (≥ 140 ms) and non-LBBB. Patients will be randomized in a 1:1 configuration:
- Standard biventricular pacing (1 right ventricular/1 left ventricular (1RV/1LV)) through classical implantation procedure without peri-operative optimization
- Triple-site biventricular pacing with individual optimization of the placement of the third lead by peri-operative echo guidance.
The objective of the optimization process is to improve LV efficiency and to decrease the left pre-ejection interval (LPEI, defined as the time interval between the onset of QRS and the onset of LV ejection) as much as possible compared with a standard biventricular configuration by moving a second right ventricular lead at different locations.
LPEI is simple to measure, with good inter- and intra-observer reproducibility and its utility has previously been strongly suggested.
Reduction in LPEI results in decreased duration of ventricular systole and is associated with improved LV filling and reduced interventricular delay.
The primary objective of this study is to demonstrate that individually optimized, triple-site biventricular pacing is superior to standard biventricular pacing in reverse ventricular modeling as demonstrated by Echo Left Ventricle End-Systolic Volume (LVESV) at 1 year in patients with non-LBBB morphology without increasing the risk of serious procedure and/or device related adverse events at 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple-site biventricular pacing | Experimental | Device: triple-site biventricular pacing with peri-operative echo guidanceTriple-site biventricular pacing with individual optimization of the placement of the third lead by peri-operative echo guidance. Devices used will be the Sorin, locally approved and commercially available Paradym SonR Tri-V CRT-D. |
| Standard biventricular pacing | Active comparator | Device: standard biventricular pacingStandard biventricular pacing (1RV/1LV) through classical implantation procedure without peri-operative optimization. Devices used will be locally approved and commercially available Sorin implantable cardioverter defibrillators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years
- Stable heart failure with New York Heart Association (NYHA) functional class II, III or ambulatory IV
- Stable optimized medical regimen according to medical guidelines (No change in heart failure medication for at least 1 month prior to enrollment)
- Left ventricular ejection fraction (LVEF) ≤ 35%
- Intrinsic QRS duration ≥ 140 msec
Key exclusion criteria (13 listed)
- Typical LBBB according to Strauss criteria
- Unstable heart failure
- Permanent or long-lasting persistent Atrial Fibrillation
- Unstable angina, acute Myocardial Infarction (MI), Coronary Artery Bypass-Grafting (CABG), or Percutaneous Transluminal Coronary Angioplasty (PTCA) within 90 days prior to enrollment (intervention)
- Conventional pacemaker indication
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 |
|---|---|---|
| triple-site biventricular pacing with peri-operative echo guidanceplacement of the third lead by peri-operative echo guidance. | Device | Triple-site biventricular pacing |
| standard biventricular pacingstandard biventricular pacing without optimization by echo guidance | Device | Standard biventricular pacing |
Primary outcome
TriV pacing is superior to standard BiV pacing in reversing ventricular modeling as demonstrated by Echo LVESV at 12 months in pts. with non LBBB without increasing the risk of serious events at 30 days.
Time frame: 12 months
The efficacy endpoint for this study is the change in LVESV at twelve months post-implant between individually optimized, triple-site biventricular pacing and standard biventricular pacing. LVESV is a standard marker of CRT effectiveness1. Echocardiographic data collected at twelve months follow-up will document the evolution of LVESV as compared to baseline in order to assess reverse ventricular remodeling. The safety endpoint for this study is the rate of all serious procedure and/or device related events reported at thirty days post-implant.
4 secondary outcomes
Evaluate serious device related complications at six and twelve months post-procedure.
Time frame: 6 and 12 months
Evaluate reverse ventricular remodeling response based on additional echocardiographic measures
Time frame: 6 and 12 months
Evaluate patient's clinical status considering New York Heart Association (NYHA) functional class improvement
Time frame: 6 and 12 months
Evaluate mortality and serious heart failure (HF) events during the procedure through discharge and at the different follow-up time-points.
Time frame: 1, 6 and 12 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 25 Mar 2019.
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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.
Jean-Claude Daubert, MD principal investigator
Hôpital Pontchaillou-CHU Rennes, France
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing triple-site biventricular pacing with peri-operative echo guidance and standard biventricular pacing in people with Heart Failure, run by MicroPort CRM at 14 sites in 6 countries.
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 7 inclusion and 13 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 25 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 14 sites in France, Spain, Germany, Italy, Netherlands and 1 more country. 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?
TriV pacing is superior to standard BiV pacing in reversing ventricular modeling as demonstrated by Echo LVESV at 12 months in pts. with non LBBB without increasing the risk of serious events at 30 days. (time frame: 12 months). 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 25 Mar 2019.