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

Information source: Haukeland University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Failure

Intervention: CRT in heart failure; Right ventricular apex v.s. high posterior septum (Device); CRT in heart failure; Right ventricular apex v.s. high posterior septum (Device)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Haukeland University Hospital

Official(s) and/or principal investigator(s):
Svein Faerestrand, MD, PhD, Principal Investigator, Affiliation: Faerestrand S

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Echocardiographic reverse remodelling and dyssynchrony

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

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 and Contacts

Haukeland University Hospital, Bergen 5021, Norway
Additional Information

Starting date: January 2009
Last updated: May 23, 2011

Page last updated: August 23, 2015

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