NCT01019213

Brief Summary

Conventional right ventricular (RV) apical pacing may result in asynchronous ventricular contraction with delayed left ventricular activation, interventricular motion abnormalities, and worsening of left ventricular ejection fraction. His pacing is preserving a synchronous contraction and may prevent a decrease in left ventricular ejection fraction. Hypothesis: His-pacing preserves left ventricular function and is a feasable alternative compared to RV septal septal pacing in patients with AV-block.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

4 years

First QC Date

November 23, 2009

Last Update Submit

May 14, 2012

Conditions

Atrioventricular Block

Keywords

His-pacing

Outcome Measures

Primary Outcomes (1)

  • Left ventricular ejection fraction (LVEF)

    12 months

Secondary Outcomes (4)

  • Quality of life

    12 months

  • Synchrony by echocardiography

    12 months

  • New York Heart Association (NYHA) class

    12

  • 6-minute hall walk test

    12

Study Arms (2)

Septal pacing

PLACEBO COMPARATOR

Septal lead will be activated.

Other: Septal pacing

His-pacing

EXPERIMENTAL

His lead will be activated 80 ms before septal lead

Other: His lead activated

Interventions

Septal pacingOTHER

Septal lead activated

Also known as: Septal lead
Septal pacing
His lead activatedOTHER

His lead will be activated 80 ms before septal lead

Also known as: His lead
His-pacing

Eligibility Criteria

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

You may qualify if:

  • nd or 3rd degree Av block

You may not qualify if:

  • QRS \> or = 120 ms
  • Indication for cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD)
  • chronic atrial fibrillation
  • Pregnant
  • Expected heart surgery \< 2 years
  • Expected survival \> 2 years
  • Patients that have been His ablated
  • Serious comorbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of cardiology Skejby Hospital

Aarhus, 8200, Denmark

Location

Related Publications (1)

  • Kronborg MB, Mortensen PT, Poulsen SH, Gerdes JC, Jensen HK, Nielsen JC. His or para-His pacing preserves left ventricular function in atrioventricular block: a double-blind, randomized, crossover study. Europace. 2014 Aug;16(8):1189-96. doi: 10.1093/europace/euu011. Epub 2014 Feb 7.

    PMID: 24509688DERIVED

MeSH Terms

Conditions

Atrioventricular Block

Condition Hierarchy (Ancestors)

Heart BlockArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Torsten T Nielsen, Professor

    Dept. B Skejby Hospital

    STUDY CHAIR

  • Jens C Nielsen, Phycisian

    Aarhus university Hospital Skajby

    STUDY CHAIR

  • Mads B Kronborg, Phycisian

    Aarhus University Hospital Skejby

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 23, 2009

First Posted

November 25, 2009

Study Start

September 1, 2007

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

DK(1)