Acute and Chronic Effect of His-pacing in Consecutive Patients With AV-block

A

Aarhus University Hospital Skejby

Status and phase

Completed
Phase 4

Conditions

Atrioventricular Block

Treatments

Other: His lead activated
Other: Septal pacing

Study type

Interventional

Funder types

Other

Identifiers

NCT01019213
07-4-B695-A1464-22378

Details and patient eligibility

About

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.

Full description

Conventional right ventricular 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. The aims of our crossover, double-blinded, randomized study is to evaluate the feasibility and long-term safety of permanent His pacing and to compare the effects on left ventricular ejection fraction of permanent His pacing with those of conventional right septal stimulation after 12 months treatment in patients with 2nd or 3rd degree AV-block.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 2nd or 3rd degree Av block

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

40 participants in 2 patient groups, including a placebo group

Septal pacing
Placebo Comparator group
Description:
Septal lead will be activated.
Treatment:
Other: Septal pacing
His-pacing
Experimental group
Description:
His lead will be activated 80 ms before septal lead
Treatment:
Other: His lead activated

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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