NCT01035489

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P50-P75 for phase_2 heart-failure

Timeline
Completed

Started Jan 2009

Typical duration for phase_2 heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

May 24, 2011

Status Verified

May 1, 2011

Enrollment Period

3.4 years

First QC Date

December 17, 2009

Last Update Submit

May 23, 2011

Conditions

Heart Failure

Keywords

Pacemaker treatment in heart failureCardiac resynchronization therapyDDD pacemakers

Outcome Measures

Primary Outcomes (1)

  • Echocardiographic reverse remodelling and dyssynchrony

    3, 6, 12, 18 and 24 months

Study Arms (2)

CRT; RV apical lead placement

ACTIVE COMPARATOR

Right ventricular apical lead placement in CRT

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

CRT; RV high posterior septum

ACTIVE COMPARATOR

High posterior septal lead placement in CRT

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

Interventions

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

RV lead is randomized to either apex or high posterior septum

CRT; RV apical lead placement

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (3)

  • Kristiansen HM, Vollan G, Hovstad T, Keilegavlen H, Faerestrand S. The impact of left ventricular lead position on left ventricular reverse remodelling and improvement in mechanical dyssynchrony in cardiac resynchronization therapy. Eur Heart J Cardiovasc Imaging. 2012 Dec;13(12):991-1000. doi: 10.1093/ehjci/jes114. Epub 2012 Jun 7.

    PMID: 22677455DERIVED

  • Kristiansen HM, Hovstad T, Vollan G, Keilegavlen H, Faerestrand S. Clinical implication of right ventricular to left ventricular interlead sensed electrical delay in cardiac resynchronization therapy. Europace. 2012 Jul;14(7):986-93. doi: 10.1093/europace/eur429. Epub 2012 Feb 2.

    PMID: 22308084DERIVED

  • Kristiansen HM, Vollan G, Hovstad T, Keilegavlen H, Faerestrand S. A randomized study of haemodynamic effects and left ventricular dyssynchrony in right ventricular apical vs. high posterior septal pacing in cardiac resynchronization therapy. Eur J Heart Fail. 2012 May;14(5):506-16. doi: 10.1093/eurjhf/hfr162. Epub 2012 Jan 26.

    PMID: 22286156DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Svein Faerestrand, MD, PhD

    Faerestrand S

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 17, 2009

First Posted

December 18, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

May 24, 2011

Record last verified: 2011-05

Locations

NO(1)