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Completed

NCT Number: NCT00887237

Triple Site Ventricular Stimulation for Cardiac Resynchronization Therapy (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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Saint Louis, La Rochelle, Île-de-France Region, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

CRT with triple site ventricular stimulation

Device

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

Conventional cardiac resynchronization

Device

Conventional cardiac resynchronization

Primary outcomes

  1. Safety of triple site CRT compared to conventional CRT

    Time frame: 6 months

Secondary outcomes

  1. Feasibility of triple site CRT

    Time frame: 6 months

  2. Left ventricle remodeling

    Time frame: At 3 and 6 months

  3. LV ejection fraction

    Time frame: At 3 and 6 months

  4. Cardiac dyssynchrony

    Time frame: At 3 and 6 months

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

    Time frame: At 3 and 6 months

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

    Time frame: At 3 and 6 months

  7. Quality of life

    Time frame: At 3 and 6 months

  8. B-Type Natriuretic Peptide (BNP) level

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

Triple Site Ventricular Stimulation for CRT Candidates

Acronym: TRIV

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 23, 2009
Registry last updated
Jul 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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