N/A
N=84
Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized Trial
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT01059175 ↗Enrolled (actual)
84
Serious AEs
79.5%
Results posted
Apr 2017
Primary outcome: Primary: Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score — 11; 7; 10; 16 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Additional Endocardial or Epicardial LV Lead (Device); CRT-P or CRT-D (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score |
8; 3; 8; 12; 26; 25 | — |
| SECONDARY Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score |
8; 3; 8; 12; 26; 25 | — |
| SECONDARY Rate of Adverse Events |
38; 34; 33; 33 | — |
| SECONDARY Changes in 6 Minutes Hall Walk Distance Observed Between the Enrollment and the End of the Study |
-15.1; 7.5 | — |
| SECONDARY Number of Patients With at Least One Hospitalization Related to Heart Failure Between Randomization and the End of the Study |
19; 22 | — |
| SECONDARY Time to First Heart Failure Related Hospitalization |
357.6; 402.4 | — |
| SECONDARY Overall Mortality |
17; 17 | — |
| SECONDARY Changes in Echocardiographic Indexes of Left Ventricle Remodeling |
-16.4; 7.0; -14.3; -2.0 | — |
| SECONDARY Changes in Quality of Life Score - Minesota Living With Heart Failure Questionnaire |
-7.33; -7.48 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01059175). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.