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

Echocardiographic Dyssynchrony in Heart Failure in CRT; Right Ventricular Apex v.s. High Posterior Septum

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01035489
Enrollment
85
Registered
2009-12-18
Start date
2009-01-31
Completion date
2012-06-30
Last updated
2011-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Pacemaker treatment in heart failure, Cardiac resynchronization therapy, DDD pacemakers

Brief summary

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.

Interventions

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

RV lead is randomized to either apex or high posterior septum

Sponsors

Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Echocardiographic reverse remodelling and dyssynchrony3, 6, 12, 18 and 24 months

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026