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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01059175
• Date of registration: 26/01/2010
• Prospective Registration: Yes
• Primary sponsor: Medtronic Bakken Research Center
• Public title: Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized Trial V3
• Scientific title: Dual-Site LV Pacing in CRT Non Responders Multicenter Randomized V3 Trial
• Date of first enrolment: September 2010
• Target sample size: 84
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01059175
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Bordachar, MD
• Affiliation: University Hospital of Bordeaux

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure

Intervention(s)

Device: Additional Endocardial or Epicardial LV Lead

Device: CRT-P or CRT-D

Primary Outcome(s)

Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score [Time Frame: 12 months]

Secondary Outcome(s)

Number of Patients With at Least One Hospitalization Related to Heart Failure Between Randomization and the End of the Study [Time Frame: 24 months]

Changes in Echocardiographic Indexes of Left Ventricle Remodeling [Time Frame: 24 months]

Rate of Adverse Events [Time Frame: 24 months]

Changes in 6 Minutes Hall Walk Distance Observed Between the Enrollment and the End of the Study [Time Frame: 24 months]

Changes in Quality of Life Score - Minesota Living With Heart Failure Questionnaire [Time Frame: 24 months]

Overall Mortality [Time Frame: 24 months]

Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score [Time Frame: 24 months]

Time to First Heart Failure Related Hospitalization [Time Frame: 24 months]

Secondary ID(s)

Medtronic

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medtronic

FRANCE

Results

• Results available: Yes
• Date Posted: 21/04/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01059175