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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00887237
First received: April 22, 2009
Last updated: July 3, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Heart Failure
Device: CRT with triple site ventricular stimulation
Device: Conventional cardiac resynchronization
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Triple Site Ventricular Stimulation for CRT Candidates

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Safety of triple site CRT compared to conventional CRT [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Feasibility of triple site CRT [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Left ventricle remodeling [ Time Frame: At 3 and 6 months ] [ Designated as safety issue: No ]
  • LV ejection fraction [ Time Frame: At 3 and 6 months ] [ Designated as safety issue: No ]
  • Cardiac dyssynchrony [ Time Frame: At 3 and 6 months ] [ Designated as safety issue: No ]
  • Functional status (clinical composite score and NYHA class) [ Time Frame: At 3 and 6 months ] [ Designated as safety issue: No ]
  • Exercise capacity (6 minutes hall walk test distance) [ Time Frame: At 3 and 6 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: At 3 and 6 months ] [ Designated as safety issue: No ]
  • B-Type Natriuretic Peptide (BNP) level [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: May 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TRIV
Cardiac resynchronization with triple site ventricular stimulation (2 RV leads and 1 LV lead)
Device: CRT with triple site ventricular stimulation
CRT with triple site ventricular stimulation (2 RV leads and 1 LV lead)
Active Comparator: BIV
Conventional cardiac resynchronization
Device: Conventional cardiac resynchronization
Conventional cardiac resynchronization

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887237

Locations
France
Hôpital Saint Louis
La Rochelle, Ile de France, France, 17000
University hospital of Bordeaux
Bordeaux, France, 33000
University hospital of Lille
Lille, France, 59000
University hospital La Timone
Marseille, France, 13000
University hospital of Montpellier
Montpellier, France, 34000
University hospital of Nancy
Nancy, France, 54000
Nouvelles Cliniques Nantaises
Nantes, France, 44000
University hospital of Nantes
Nantes, France, 44000
Clinique Bizet
Paris, France, 75016
University Hospital of Rennes
Rennes, France, 35000
University hospital of Rouen
Rouen, France, 76031
Centre Cardiologique du Nord
Saint Denis, France, 93200
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Principal Investigator: Frederic Anselme, Pr University Hospital, Rouen
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00887237     History of Changes
Other Study ID Numbers: TRIV
Study First Received: April 22, 2009
Last Updated: July 3, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
France: French Data Protection Authority

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Heart failure
Cardiac resynchronization
Triple site ventricular pacing

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014