Cardiac Resynchronization TherapyTRIPLEADNCT02962791
Prospective Randomized Trial Comparing TRIPLE Site ventriculAr Stimulation Versus Conventional Pacing in CRT canDidates
A study testing Cardiac resynchronization therapy implantation, Stimulation of 3 ventricular sites and Stimulation of 2 ventricular sites in people with Cardiac Resynchronization Therapy, run by University Hospital, Rouen at 1 site in France.
Trial summary
Cardiac resynchronization therapy (CRT) is a recommended treatment for selected patients with symptomatic heart failure (HF). Although most treated patients show a benefit from CRT, a lack of response is observed for about 25-30% of them whatever the response criteria used either based on the clinical status (NYHA… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Resynchronization Therapy
- What is being tested?
- Cardiac resynchronization therapy implantation, Stimulation of 3 ventricular sites and Stimulation of 2 ventricular sites
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 24 Oct 2017to 20 Nov 2020
- 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
- Patient who signed the MEC approved informed consent
- Patient older than 18
- Patient with a CRT (CRT-P or D) indication as per ESC guidelines 2013
- Left Ventricular Ejection Fraction (LVEF) ≤ 35%
- NYHA class II/III/IV despite optimal medical treatment
- Left Bundle Branch Block (LBBB) and QRS ≥ 120 ms (class IA and IB indications) or in the absence of LBBB QRS > 150 ms (class IIA indication)
- De novo implantation
- Sinus rhythm
Who cannot join
- Permanent supra ventricular tachycardia
- Pacing indication for 3rd degree AV block
- Impossibility to perform FU at the investigative center
- Pregnancy
- Adults under legal protection
- Heart transplant candidates
- Concomitant pathology that may interfere with the study results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Trial Comparing TRIPLE Site ventriculAr Stimulation Versus Conventional Pacing in CRT canDidates: TRIPLEAD Trial
Cardiac resynchronization therapy (CRT) is a recommended treatment for selected patients with symptomatic heart failure (HF). Although most treated patients show a benefit from CRT, a lack of response is observed for about 25-30% of them whatever the response criteria used either based on the clinical status (NYHA class, Packer clinical composite score) or on ventricular remodeling parameters assessed by echography (Left ventricle end of systole volume). This rate has remained remarkably stable since the therapy started and has motivated many studies to better understand the underlying physiopathology and the CRT action mechanisms.
Among the various research axes to improve CRT response and responders rate, increasing the number of pacing sites in an attempt to better homogenize the cardiac mechanical activity has been evaluated. A configuration with two RV leads and one LV lead was tested acutely in three studies. In all cases, it demonstrated a significant improvement of cardiac performance whether assessed by echographic parameters or LV dp/dt measurements. Additionally feasibility of this approach for long term CRT delivery was demonstrated during a previous study. First results with triple-site ventricular stimulation are encouraging and its clinical efficacy should now be tested on a larger population in order to conclude on its interest for CRT candidates.
- Conditions
- Cardiac Resynchronization Therapy
- Being tested
- Cardiac resynchronization therapy implantation, Stimulation of 3 ventricular sites, Stimulation of 2 ventricular sites, Echocardiography
- Keywords
- symptomatic heart failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac resynchronization therapy implantationProcedure or surgery
Cardiac resynchronization therapy implantation will be done for patient with symptomatic heart failure
Stimulation of 3 ventricular sitesDevice
Cardiac resynchronization therapy with stimulation of 3 ventricular sites
Stimulation of 2 ventricular sitesDevice
Cardiac resynchronization therapy with stimulation of 2 ventricular sites
EchocardiographyDevice
Standard Echocardiography will de bone for patient
| Study group | Role | What they receive |
|---|---|---|
| Stimulation of 3 ventricular sites | Experimental | Cardiac resynchronization therapy implantation wil be done as usual, except the additional stimulation lead. Standard Echocardiography will be done at one year Receives: Procedure: Cardiac resynchronization therapy implantation; Device: Stimulation of 3 ventricular sites; Device: Echocardiography |
| Stimulation of 2 ventricular sites | Active comparator | Cardiac resynchronization therapy implantation wil be done as usual. Standard Echocardiography will be done at one year Receives: Procedure: Cardiac resynchronization therapy implantation; Device: Stimulation of 2 ventricular sites; Device: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference from baseline in Left Ventricular End-Systolic Volume
Left Ventricular End-Systolic Volume will be evaluated using echocardiography
Measured: 12 months
Secondary outcomes (3)
Difference from baseline in left ventricular remodelling
Left ventricular remodelling will be evaluated using echocardiography
Measured: 12 months
Number of patients alive
Measured: 12 months
Number of adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study start24 Oct 2017
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Why it stopped: Difficulty in resuming inclusions following the COVID-19 crises
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Resynchronization TherapyStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric ANSELME, Pr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962791
- Sponsor's protocol ID
- 2016/091/HP
- Acronym
- TRIPLEAD
- Status last verified
- Feb 2026
- First submitted
- 9 Nov 2016
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Comparing TRIPLE Site ventriculAr Stimulation Versus Conventional Pacing in CRT canDidates: TRIPLEAD Trial
- ClinicalTrials.gov ID
- NCT02962791
- Acronym / sponsor ID
- TRIPLEAD / 2016/091/HP
- Conditions
- Cardiac Resynchronization Therapy
- Keywords
- symptomatic heart failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in resuming inclusions following the COVID-19 crises
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 11 Nov 2016 (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 therapy (CRT) is a recommended treatment for selected patients with symptomatic heart failure (HF). Although most treated patients show a benefit from CRT, a lack of response is observed for about 25-30% of them whatever the response criteria used either based on the clinical status (NYHA class, Packer clinical composite score) or on ventricular remodeling parameters assessed by echography (Left ventricle end of systole volume). This rate has remained remarkably stable since the therapy started and has motivated many studies to better understand the underlying physiopathology and the CRT action mechanisms.
Among the various research axes to improve CRT response and responders rate, increasing the number of pacing sites in an attempt to better homogenize the cardiac mechanical activity has been evaluated. A configuration with two RV leads and one LV lead was tested acutely in three studies. In all cases, it demonstrated a significant improvement of cardiac performance whether assessed by echographic parameters or LV dp/dt measurements. Additionally feasibility of this approach for long term CRT delivery was demonstrated during a previous study. First results with triple-site ventricular stimulation are encouraging and its clinical efficacy should now be tested on a larger population in order to conclude on its interest for CRT candidates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulation of 3 ventricular sites | Experimental | Procedure: Cardiac resynchronization therapy implantation, Device: Stimulation of 3 ventricular sites, Device: EchocardiographyCardiac resynchronization therapy implantation wil be done as usual, except the additional stimulation lead. Standard Echocardiography will be done at one year |
| Stimulation of 2 ventricular sites | Active comparator | Procedure: Cardiac resynchronization therapy implantation, Device: Stimulation of 2 ventricular sites, Device: EchocardiographyCardiac resynchronization therapy implantation wil be done as usual. Standard Echocardiography will be done at one year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient who signed the MEC approved informed consent
- Patient older than 18
- Patient with a CRT (CRT-P or D) indication as per ESC guidelines 2013
- Left Ventricular Ejection Fraction (LVEF) ≤ 35%
- NYHA class II/III/IV despite optimal medical treatment
Key exclusion criteria (7 listed)
- Permanent supra ventricular tachycardia
- Pacing indication for 3rd degree AV block
- Impossibility to perform FU at the investigative center
- Pregnancy
- Adults under legal protection
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 |
|---|---|---|
| Cardiac resynchronization therapy implantationCardiac resynchronization therapy implantation will be done for patient with symptomatic heart failure | Procedure or surgery | Stimulation of 2 ventricular sites, Stimulation of 3 ventricular sites |
| Stimulation of 3 ventricular sitesCardiac resynchronization therapy with stimulation of 3 ventricular sites | Device | Stimulation of 3 ventricular sites |
| Stimulation of 2 ventricular sitesCardiac resynchronization therapy with stimulation of 2 ventricular sites | Device | Stimulation of 2 ventricular sites |
| EchocardiographyStandard Echocardiography will de bone for patient | Device | Stimulation of 2 ventricular sites, Stimulation of 3 ventricular sites |
Primary outcome
Difference from baseline in Left Ventricular End-Systolic Volume
Time frame: 12 months
Left Ventricular End-Systolic Volume will be evaluated using echocardiography
3 secondary outcomes
Difference from baseline in left ventricular remodelling
Time frame: 12 months
Number of patients alive
Time frame: 12 months
Number of adverse events
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Difficulty in resuming inclusions following the COVID-19 crises). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Cardiac Resynchronization Therapy
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A Comparison of Left Bundle Branch Optimized Cardiac Resynchronization Therapy vs Left Bundle Branch Area Pacing Alone
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Comparison of the Effects of Different Upper Extremity Aerobic Exercise Training Protocols on Arm Functional Capacity in Patients With Heart Failure With Cardiac Implantable Electronic Devices
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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.
Frédéric ANSELME, Pr principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac resynchronization therapy implantation, Stimulation of 3 ventricular sites and Stimulation of 2 ventricular sites in people with Cardiac Resynchronization Therapy, run by University Hospital, Rouen at 1 site in France.
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 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: stopped early, as of the sponsor's last update on 29 Apr 2026. 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 France. 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 was stopped early (reason given: Difficulty in resuming inclusions following the COVID-19 crises). Results are not available in the source record.
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?
Difference from baseline in Left Ventricular End-Systolic Volume (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 29 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.