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
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