Triple Site Ventricular Stimulation for Cardiac Resynchronization Therapy (CRT) Candidates (TRIV)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Medtronic Cardiac Rhythm Disease Management.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Medtronic Cardiac Rhythm Disease Management
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00887237
First received: April 22, 2009
Last updated: April 27, 2011
Last verified: April 2011
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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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | July 2012 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887237
Contacts
| Contact: Marc Mainardis | +33155381700 ext 1725 | marc.mainardis@medtronic.com |
Locations
| France | |
| Hôpital Saint Louis | Not yet recruiting |
| La Rochelle, Ile de France, France, 17000 | |
| Contact: Antoine Milhem, Dr +33546456641 | |
| Principal Investigator: Antoine Milhem, Dr | |
| University hospital of Bordeaux | Recruiting |
| Bordeaux, France, 33000 | |
| Contact: Pierre Bordachar, MD pierre.bordachar@chu-bordeaux.fr | |
| Principal Investigator: Pierre Bordachar, MD | |
| University hospital of Lille | Recruiting |
| Lille, France, 59000 | |
| Contact: Salem Kacet, Pr skacet@chru-lille.fr | |
| Principal Investigator: Salem Kacet, Pr | |
| University hospital La Timone | Recruiting |
| Marseille, France, 13000 | |
| Contact: Jean Claude Deharo, Pr jean-claude.deharo@mail.ap-hm.fr | |
| Principal Investigator: Deharo Jean Claude, Pr | |
| University hospital of Montpellier | Recruiting |
| Montpellier, France, 34000 | |
| Contact: Jean Marc Davy, Pr jm-davy@chu-montpellier.fr | |
| Principal Investigator: Jean Marc Davy, Pr | |
| University hospital of Nancy | Not yet recruiting |
| Nancy, France, 54000 | |
| Contact: Nicolas Sadoul, Pr n.sadoul@chu-nancy.fr | |
| Principal Investigator: Nicolas Sadoul, Pr | |
| Nouvelles Cliniques Nantaises | Recruiting |
| Nantes, France, 44000 | |
| Contact: Daniel Gras, MD dangras@aol.com | |
| Principal Investigator: Daniel Gras, MD | |
| University hospital of Nantes | Recruiting |
| Nantes, France, 44000 | |
| Contact: Vincent Probst, Pr vincent.probst@chu-nantes.fr | |
| Principal Investigator: Vincent Probst, Pr | |
| Clinique Bizet | Recruiting |
| Paris, France, 75016 | |
| Contact: Christine Alonso, MD christine.alonso@wanadoo.fr | |
| Principal Investigator: Christine Alonso, MD | |
| University Hospital of Rennes | Recruiting |
| Rennes, France, 35000 | |
| Contact: Christophe Leclercq, MD christophe.leclercq@chu-rennes.fr | |
| Principal Investigator: Christophe Leclercq, MD | |
| University hospital of Rouen | Recruiting |
| Rouen, France, 76031 | |
| Contact: Frederic Anselme, Pr +33232888111 frederic.anselme@chu-rouen.fr | |
| Principal Investigator: Frederic Anselme, Pr | |
| Centre Cardiologique du Nord | Recruiting |
| Saint Denis, France, 93200 | |
| Contact: Olivier Piot, MD o.piot@ccncardio.com | |
| Principal Investigator: Olivier Piot, MD | |
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
| Principal Investigator: | Frederic Anselme, Pr | University Hospital, Rouen |
More Information
No publications provided
| Responsible Party: | Marc Mainardis - Medtronic France CRDM clinical studies responsible, Medtronic France |
| ClinicalTrials.gov Identifier: | NCT00887237 History of Changes |
| Other Study ID Numbers: | TRIV |
| Study First Received: | April 22, 2009 |
| Last Updated: | April 27, 2011 |
| 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 June 18, 2013