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Heart FailurePhase 3TRIVNCT00887237

Triple Site Ventricular Stimulation for Cardiac Resynchronization Therapy (CRT) Candidates

A Phase 3 study testing CRT with triple site ventricular stimulation and Conventional cardiac resynchronization in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 12 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Despite technological progresses the rate of non-responders to cardiac resynchronization therapy (CRT) remains close to 30%. This inconsistent effect of CRT might be due to incomplete resynchronization as dyssynchrony can persist in 25% to 30% of patients during CRT. 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?
CRT with triple site ventricular stimulation and Conventional cardiac resynchronization
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
12 sitesFrance
Study dates
May 2009to Jul 2012
Phase
Phase 3
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

  • Signed informed consent
  • > 18 years old
  • Cardiac resynchronization indication : New York Heart Association (NYHA) Class III/IV \& QRS width > 120 ms milliseconds (ms) OR NYHA class II \& QRS width > 150 ms
  • Sinus rhythm
  • First implant procedure

Who cannot join

  • Permanent ventricular tachycardia
  • Permanent pacing indication for 3rd degree atrioventricular (AV) block
  • Diagnosed or suspected acute myocarditis
  • Less than 1 year life expectancy related to a non-cardiovascular disease
  • Impossibility to perform follow-up in the investigative center
  • Pregnant woman
Show all 13Show fewer
  • Patient which may not cooperate to study procedures as evaluated by investigator
  • Legally protected adult patient or patient unable to give an informed consent
  • Patient enrolled in an other clinical trial
  • Patient which does not benefit from a social protection system
  • Renal insufficiency
  • Patient registered on a heart transplant waiting list
  • Disease and/or health condition which may interfere with study results

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • University hospital of Bordeaux

    Bordeaux, 33000

  • Hôpital Saint Louis

    La Rochelle, Île-de-France Region, 17000

  • University hospital of Lille

    Lille, 59000

  • University hospital La Timone

    Marseille, 13000

  • University hospital of Montpellier

    Montpellier, 34000

  • University hospital of Nancy

    Nancy, 54000

  • Nouvelles Cliniques Nantaises

    Nantes, 44000

  • University hospital of Nantes

    Nantes, 44000

  • Clinique Bizet

    Paris, 75016

  • University Hospital of Rennes

    Rennes, 35000

  • University hospital of Rouen

    Rouen, 76031

  • Centre Cardiologique du Nord

    Saint-Denis, 93200

Other trials in France

About this study

Official title: Triple Site Ventricular Stimulation for CRT Candidates

Despite technological progresses the rate of non-responders to cardiac resynchronization therapy (CRT) remains close to 30%. This inconsistent effect of CRT might be due to incomplete resynchronization as dyssynchrony can persist in 25% to 30% of patients during CRT.

One might hypothesize that stimulating the ventricles at a single site is suboptimal and that stimulating multiple left ventricular (LV) or right ventricular (RV) sites may improve ventricular resynchronization and, consequently, its hemodynamic and clinical effects. First studies have suggested that 1 RV + 2 LV pacing sites configurations increased significantly dP/dt, pulse pressure, LV end-diastolic pressure, and is associated with more LV remodeling and better responder rate compared with pacing a single LV site. First studies with 2 RV+LV pacing sites configuration demonstrated increased dP/dt and cardiac output and a decrease of the cardiac dyssynchrony.

The present pilot trial was designed to examine the 6-month safety of biventricular stimulation with 2 right ventricular (RV) and 1 left ventricular (LV) leads - main objective- and to assess its clinical benefit.

Conditions
Heart Failure
Being tested
CRT with triple site ventricular stimulation, Conventional cardiac resynchronization
Keywords
Heart failure, Cardiac resynchronization, Triple site ventricular pacing
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CRT with triple site ventricular stimulationDevice

    CRT with triple site ventricular stimulation (2 RV leads and 1 LV lead)

  • Conventional cardiac resynchronizationDevice

    Conventional cardiac resynchronization

Study groups in NCT00887237
Study groupRoleWhat they receive
TRIVExperimentalCardiac resynchronization with triple site ventricular stimulation (2 RV leads and 1 LV lead)
Receives: Device: CRT with triple site ventricular stimulation
BIVActive comparatorConventional cardiac resynchronization
Receives: Device: Conventional cardiac resynchronization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of triple site CRT compared to conventional CRT

    Measured: 6 months

Secondary outcomes (8)

  1. Feasibility of triple site CRT

    Measured: 6 months

  2. Left ventricle remodeling

    Measured: At 3 and 6 months

  3. LV ejection fraction

    Measured: At 3 and 6 months

  4. Cardiac dyssynchrony

    Measured: At 3 and 6 months

  5. Functional status (clinical composite score and NYHA class)

    Measured: At 3 and 6 months

  6. Exercise capacity (6 minutes hall walk test distance)

    Measured: At 3 and 6 months

  7. Quality of life

    Measured: At 3 and 6 months

  8. B-Type Natriuretic Peptide (BNP) level

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00887237
Sponsor's protocol ID
TRIV
Acronym
TRIV
Status last verified
Jul 2013
First submitted
22 Apr 2009
Last updated
8 Jul 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Anselme F, Bordachar P, Pasquie JL, Klug D, Leclercq C, Milhem A, Alonso C, Deharo JC, Gras D, Probst V, Piot O, Savoure A. Safety, feasibility, and outcome results of cardiac resynchronization with triple-site ventricular stimulation compared to conventional cardiac resynchronization. Heart Rhythm. 2016 Jan;13(1):183-9. doi: 10.1016/j.hrthm.2015.08.036. Epub 2015 Sep 26.

    PubMed 26325531

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CRT with triple site ventricular stimulation and Conventional cardiac resynchronization in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 12 sites 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 5 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 8 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Safety of triple site CRT compared to conventional CRT (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 NCT00887237, 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 8 Jul 2013; AzTrials last refreshed its copy on 6 Nov 2026.

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