TRI-V Heart Failure (HF) Implanted Cardioverter Defibrillator (ICD) Study

Abbott

Status: Completed

Conditions: Heart Failure

Treatments: Device: Device Implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00746135

H37

Details and patient eligibility

About

It's the aim of this study to investigate the impact of Right Ventricular (RV) lead position (RV-apex, His bundle area, RV-apex+His bundle area) in combination with individually optimized Left Ventricular (LV) lead placement and CRT timing on the outcome of cardiac resynchronization therapy (CRT).

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with indication for CRT-D: NYHA III-IV congestive heart failure, in spite of optimal medical treatment for their congestive heart failure
• LVEDD > 55 mm or > 30 mm/m² BSA
• EF < 35%
• Sinus rhythm and one of the following criteria:
• QRS >= 120 ms and PQ >= 200ms
• or
• 2nd / 3rd degree AV block
• Written informed consent

Exclusion criteria

• pacemaker indication (without ICD indication)
• tricuspidal valve and/or aortic valve replacement
• Indication for revascularization.
• less than 3 month after heart surgery or myocardial infarction
• hypertrophic obstructive cardiomyopathy
• intravenous catecholamine treatment
• uncorrected thyroid function
• severe kidney disorder (creatinin >2,5mg%)
• no written patient consent
• insufficient patient compliance
• participating in another study
• life expectancy < 1 year due to other severe disease
• age < 18 years
• no contraception (young women) or pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 3 patient groups

A

Active Comparator group

Description:

Conventional Biventricular Stimulation: RV Apex and LV Lead Tip

Treatment:

Device: Device Implantation

B

Active Comparator group

Description:

Anodal-Cathodal Biventricular Stimulation: cathodal LV Stimulation und anodal RVHis Stimulation = "Anodal-cathodal Bi-V".

Treatment:

Device: Device Implantation

C

Active Comparator group

Description:

Anodal-Cathodal Tri-V Stimulation: RV-apex and LV and RV-His

Treatment:

Device: Device Implantation