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Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized Trial (V3)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Additional Endocardial or Epicardial LV Lead
CRT-P or CRT-D
Sponsored by
Medtronic Bakken Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Cardiac resynchronization therapy, Biventricular stimulation, Multisite stimulation, Non responders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age greater than 18 years
  • Recipient of a CRT-P or CRT-D system for greater than 6 for standard indications, including LV ejection fraction greater than 35 percent and New York Heart Association (NYHA) functional class III or IV
  • Optimized biventricular stimulation and medical therapy since implantation of the system
  • Presence of sinus rhythm, or atrial fibrillation with spontaneous or induced complete atrio-ventricular block
  • Greater than 93 percent LV stimulation since the last device interrogation, with a LV capture threshold less than 5.0 Volts/0.5 milliseconds
  • Unchanged or worsened clinical status by CRT, according to the HF composite endpoint described by M. Packer, in absence of a reversible cause
  • Signature of a written, informed consent to participate in the trial

Exclusion Criteria:

  • LV lead location in the great cardiac vein
  • Life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders
  • Chronic renal dialysis
  • Concomitant disorder which might interfere with the results of the V3 trial
  • Blood systolic pressure greater than 180 millimeters of mercury (mmHg) or diastolic pressure greater than 95 mmHg despite optimal medical management
  • History of stroke, myocardial infarction or unstable angina pectoris within the last 3 months
  • Presence of correctible valvular disease
  • Subject unable to attend follow-up at the investigative center or unable, for physical or mental reasons, to comply with the trial's procedures, or to sign the informed consent
  • Subject is pregnant
  • Subject participates in another research project

Sites / Locations

  • University hospital Rennes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CRT With Dual Site LV Pacing

Standard CRT

Arm Description

Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.

Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.

Outcomes

Primary Outcome Measures

Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score
M. Packer's clinical composite score: patients were classified into 1 of 3 response groups after 12 months follow up : worsened, unchanged, or improved. Worsened : if death, hospitalization because of or associated with worsening HF, demonstrated worsening in NYHA functional class at their 12-month visit, or if investigator judges global clinical state has worsened. Improved :if they had not worsened and had demonstrated improvement in NYHA functional class, or or if investigator judges global clinical state has improved. Unchanged : if none of the previous definition applies.

Secondary Outcome Measures

Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score
Distribution of "improved", "unchanged" and "worsened" patients as defined per M. Packer's clinical composite score at 24 months post implantation of the second left ventricle lead in comparison to the control group M. Packer's clinical composite score: patients were classified into 1 of 3 response groups after 24 months follow up : worsened, unchanged, or improved. Worsened : if death, hospitalization because of or associated with worsening HF, demonstrated worsening in NYHA functional class at their 24-month visit, or if investigator judges global clinical state has worsened. Improved :if they had not worsened and had demonstrated improvement in NYHA functional class, or or if investigator judges global clinical state has improved. Unchanged : if none of the previous definition applies.
Rate of Adverse Events
Changes in 6 Minutes Hall Walk Distance Observed Between the Enrollment and the End of the Study
Changes between baseline and 24months follow up
Number of Patients With at Least One Hospitalization Related to Heart Failure Between Randomization and the End of the Study
Time to First Heart Failure Related Hospitalization
Overall Mortality
Changes in Echocardiographic Indexes of Left Ventricle Remodeling
Changes between baseline and 24months follow up
Changes in Quality of Life Score - Minesota Living With Heart Failure Questionnaire
Changes between baseline and 24 months follow up Minesota Living with Heart Failure Questionnaire: 21 questions - addition of scores from 1 (better) to 5 (worse) for each questions.

Full Information

First Posted
January 26, 2010
Last Updated
April 18, 2017
Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic, FRANCE
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1. Study Identification

Unique Protocol Identification Number
NCT01059175
Brief Title
Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized Trial
Acronym
V3
Official Title
Dual-Site LV Pacing in CRT Non Responders Multicenter Randomized V3 Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Bakken Research Center
Collaborators
Medtronic, FRANCE

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cardiac resynchronization therapy (CRT) is an effective treatment of heart failure (HF) refractory to optimal medical management, in presence of a depressed left ventricular (LV) ejection fraction and a wide QRS complex. It is mainly limited by a high proportion of non-responders. Attempts have been made, in small studies, to increase the number of stimulation sites in order to optimize the resynchronization therapy. V3 is a planned multicenter, randomized trial whose objective is to evaluate the clinical benefit conferred by the addition of a second endocardial or epicardial LV lead in non-responders after at least 6 months of standard biventricular stimulation. The V3 trial will examine the clinical benefit conferred by the addition of a second LV lead in non-responders compared to standard CRT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Cardiac resynchronization therapy, Biventricular stimulation, Multisite stimulation, Non responders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRT With Dual Site LV Pacing
Arm Type
Experimental
Arm Description
Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.
Arm Title
Standard CRT
Arm Type
Active Comparator
Arm Description
Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.
Intervention Type
Device
Intervention Name(s)
Additional Endocardial or Epicardial LV Lead
Intervention Description
Addition of a second left ventricular endocardial or epicardial lead
Intervention Type
Device
Intervention Name(s)
CRT-P or CRT-D
Intervention Description
Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device
Primary Outcome Measure Information:
Title
Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score
Description
M. Packer's clinical composite score: patients were classified into 1 of 3 response groups after 12 months follow up : worsened, unchanged, or improved. Worsened : if death, hospitalization because of or associated with worsening HF, demonstrated worsening in NYHA functional class at their 12-month visit, or if investigator judges global clinical state has worsened. Improved :if they had not worsened and had demonstrated improvement in NYHA functional class, or or if investigator judges global clinical state has improved. Unchanged : if none of the previous definition applies.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score
Description
Distribution of "improved", "unchanged" and "worsened" patients as defined per M. Packer's clinical composite score at 24 months post implantation of the second left ventricle lead in comparison to the control group M. Packer's clinical composite score: patients were classified into 1 of 3 response groups after 24 months follow up : worsened, unchanged, or improved. Worsened : if death, hospitalization because of or associated with worsening HF, demonstrated worsening in NYHA functional class at their 24-month visit, or if investigator judges global clinical state has worsened. Improved :if they had not worsened and had demonstrated improvement in NYHA functional class, or or if investigator judges global clinical state has improved. Unchanged : if none of the previous definition applies.
Time Frame
24 months
Title
Rate of Adverse Events
Time Frame
24 months
Title
Changes in 6 Minutes Hall Walk Distance Observed Between the Enrollment and the End of the Study
Description
Changes between baseline and 24months follow up
Time Frame
24 months
Title
Number of Patients With at Least One Hospitalization Related to Heart Failure Between Randomization and the End of the Study
Time Frame
24 months
Title
Time to First Heart Failure Related Hospitalization
Time Frame
24 months
Title
Overall Mortality
Time Frame
24 months
Title
Changes in Echocardiographic Indexes of Left Ventricle Remodeling
Description
Changes between baseline and 24months follow up
Time Frame
24 months
Title
Changes in Quality of Life Score - Minesota Living With Heart Failure Questionnaire
Description
Changes between baseline and 24 months follow up Minesota Living with Heart Failure Questionnaire: 21 questions - addition of scores from 1 (better) to 5 (worse) for each questions.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age greater than 18 years Recipient of a CRT-P or CRT-D system for greater than 6 for standard indications, including LV ejection fraction greater than 35 percent and New York Heart Association (NYHA) functional class III or IV Optimized biventricular stimulation and medical therapy since implantation of the system Presence of sinus rhythm, or atrial fibrillation with spontaneous or induced complete atrio-ventricular block Greater than 93 percent LV stimulation since the last device interrogation, with a LV capture threshold less than 5.0 Volts/0.5 milliseconds Unchanged or worsened clinical status by CRT, according to the HF composite endpoint described by M. Packer, in absence of a reversible cause Signature of a written, informed consent to participate in the trial Exclusion Criteria: LV lead location in the great cardiac vein Life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders Chronic renal dialysis Concomitant disorder which might interfere with the results of the V3 trial Blood systolic pressure greater than 180 millimeters of mercury (mmHg) or diastolic pressure greater than 95 mmHg despite optimal medical management History of stroke, myocardial infarction or unstable angina pectoris within the last 3 months Presence of correctible valvular disease Subject unable to attend follow-up at the investigative center or unable, for physical or mental reasons, to comply with the trial's procedures, or to sign the informed consent Subject is pregnant Subject participates in another research project
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bordachar, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
20797593
Citation
Bordachar P, Alonso C, Anselme F, Boveda S, Defaye P, Garrigue S, Gras D, Klug D, Piot O, Sadoul N, Leclercq C. Addition of a second LV pacing site in CRT nonresponders rationale and design of the multicenter randomized V(3) trial. J Card Fail. 2010 Sep;16(9):709-13. doi: 10.1016/j.cardfail.2010.04.010. Epub 2010 Jun 8.
Results Reference
background
PubMed Identifier
29288035
Citation
Bordachar P, Gras D, Clementy N, Defaye P, Mondoly P, Boveda S, Anselme F, Klug D, Piot O, Sadoul N, Babuty D, Leclercq C. Clinical impact of an additional left ventricular lead in cardiac resynchronization therapy nonresponders: The V3 trial. Heart Rhythm. 2018 Jun;15(6):870-876. doi: 10.1016/j.hrthm.2017.12.028. Epub 2017 Dec 26.
Results Reference
derived

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Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized Trial

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