Trial in Cardiac Resynchronization Therapy (CRT): Right Ventricular Apex Versus High Posterior Septum

Haukeland University Hospital85 enrolled

Overview

In heart failure patients we hypothesised that right ventricular high posterior septum is superior to right ventricular apex in CRT and DDD pacemaker. In two separate trials we prospectively randomized the right ventricular lead placement to find evidence of differences in heart failure symptoms (NYHA-class), 6 minute hall walk and echocardiographic measurements of reverse remodelling and dyssynchrony.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

CRT in heart failure; Right ventricular apex v.s. high posterior septumDEVICE

RV lead is randomized to either apex or high posterior septum

CRT in heart failure; Right ventricular apex v.s. high posterior septumDEVICE

RV lead is randomized to either apex or high posterior septum

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * CRT: * LVEF \< 35% * LVEDD \> 5.5 cm * NYHA 3-4 * QRS \> 120 ms * Optimal medical treatment * Both CRT-pacemakers (CRT-P) and CRT combined with ICD (CRT-D) Exclusion Criteria: * Not fulfilling inclusion criteria or not written consensus

Locations (1)

Haukeland University Hospital

Bergen, Norway

Outcomes

Primary Outcomes

Echocardiographic reverse remodelling and dyssynchrony

Time frame: 3, 6, 12, 18 and 24 months

Data from ClinicalTrials.gov

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