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

Launched by MEDTRONIC CARDIAC RHYTHM AND HEART FAILURE · Jan 28, 2010

Keywords

ClinConnect Summary

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Gender

ALL

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