Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT00658203
Eligibility Criteria:
Inclusion Criteria:
The patient candidate for inclusion in the study must be indicated for implantation of a Biventricular pacing system, with the following clinical conditions:
* Severe Heart Failure (NYHA Class III or IV)
* Cardiomyopathy of any etiology
* Sinus rhythm
* Reduced Left-Ventricular Ejection Fraction
* Left-Ventricular End Diastolic Diameter greater than or equal to 30 mm/m2 (LVEDD\>30 mm/m2)
* QRS Duration:
* \> 150 ms or
* \> 120 ms and documented Mechanical Dissynchrony (by ECHO) meeting two out of three of the following criteria:
* Aortic Pre-Ejection Delay \> 140 ms
* Interventricular Mechanical Delay \> 40 ms
* Delayed activation of postero-lateral Left Ventricular wall (after mitral valve opening)
* Optimal and stable (1 month before inclusion) pharmacological treatment, including, if tolerated, Beta Blockers, Angiotensin-Converting Enzyme (ACE) Inhibitors or ACE Inhibitor substitutes, Spironolactone, and diuretics
Exclusion Criteria:
Any patient who has one of the following characteristics will be excluded from the study:
* ICD indication (Life-threatening ventricular arrhythmias)
* Persistent or permanent Atrial Arrhythmia without possibility to restore sinus rhythm (spontaneous termination, anti-tachycardia pacing, pharmacological or electrical cardioversion).
* Patient already implanted with a conventional pacemaker device
* Myocardial infarction within the last three months
* Heart surgery, or revascularization within the last three months, or expected
* Heart surgery refused because of co-morbidity factors
* Included in transplantation list
* Already enrolled in other study
* Life expectancy less than 1 year
* Pregnancy
* Age less than 18
* Forfeiture of freedom or under guardianship
* Not able to understand the aim of the study and its procedures
* Refusing to cooperate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00658203
Study Brief:
Protocol Section:
NCT00658203