Cardiac Resynchronization Therapy (CRT)-Narrow-dp/Dt-Study (CRT-Narrow)

Medtronic

Status and phase: Completed; Phase 4

Conditions: Heart Failure

Treatments: Procedure: LV dp/dt pressure measurement

Study type: Interventional

Funder types: Industry

Identifiers

NCT00821938

CEN_G_CA_10

Details and patient eligibility

About

Goal is to examine the efficy of Cardiac Resynchronization Therapy in heart failure patients with narrow QRS complex and optimized medical treatment but echocardiographic desynchronization detection as well as the positve increase of the intraoperative pressureincreasespeed in reverse remodelling and a secondary improvement of functional parameters

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• EF < 35%
• CHD or dilate cardiomyopathy
• sinus rhythm
• NYHA III (or IV but stable recompenstated)
• QRS < 120 ms 2-3 of the following:
• LV-fillingtime < 40% of the cyclelength
• TDI septal-lateral (LV basal) > 60ms
• 2D-Strain-Score > 9 points

Exclusion criteria

• tricuspid or artificial valve
• AV block II or III or PQ time > 250ms
• revasculisation or condition after cardiac surgery < 3 months
• myocardial infarction or bypass OP < 3 months
• hytertrphic obstructive cardiomyopathy, constrictive pericarditis
• intravenous catecholamines because of HF
• manifeste hyperthyreoses
• kidney failure (creatine >2,5 mg/dl)
• no written informed consent
• no compliance
• participation in another study
• life expectancy < 1 year
• patients < 18 years
• pragnancy or no safe contraception

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups, including a placebo group

CRT-ICD

Active Comparator group

Treatment:

Procedure: LV dp/dt pressure measurement

Procedure: LV dp/dt pressure measurement

DDD-ICD

Placebo Comparator group

Treatment:

Procedure: LV dp/dt pressure measurement

Procedure: LV dp/dt pressure measurement