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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CRT; RV apical lead placement

Right ventricular apical lead placement in CRT

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

RV lead is randomized to either apex or high posterior septum

CRT; RV high posterior septum

High posterior septal lead placement in CRT

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

RV lead is randomized to either apex or high posterior septum

Interventions

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

RV lead is randomized to either apex or high posterior septum

Intervention Type DEVICE

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

RV lead is randomized to either apex or high posterior septum

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No