Overview

This trial is active, not recruiting.

Condition heart failure
Treatments crt in heart failure; right ventricular apex v.s. high posterior septum
Phase phase 2
Sponsor Haukeland University Hospital
Start date January 2009
End date June 2012
Trial size 85 participants
Trial identifier NCT01035489, 2009/1991

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Right ventricular apical lead placement in CRT
crt in heart failure; right ventricular apex v.s. high posterior septum
RV lead is randomized to either apex or high posterior septum
(Active Comparator)
High posterior septal lead placement in CRT
crt in heart failure; right ventricular apex v.s. high posterior septum
RV lead is randomized to either apex or high posterior septum

Primary Outcomes

Measure
Echocardiographic reverse remodelling and dyssynchrony
time frame: 3, 6, 12, 18 and 24 months

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title Echocardiographic Dyssynchrony in Heart Failure in CRT; Right Ventricular Apex v.s. High Posterior Septum
Principal investigator Svein Faerestrand, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2011.
Information provided to ClinicalTrials.gov by Haukeland University Hospital.