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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01019213

Enrollment

Registered

2009-11-25

Start date

2007-09-30

Completion date

2011-09-30

Last updated

2012-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrioventricular Block

Keywords

His-pacing

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.

Detailed 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.

Interventions

OTHERSeptal pacing

Septal lead activated

OTHERHis lead activated

His lead will be activated 80 ms before septal lead

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Left ventricular ejection fraction (LVEF)	12 months

Secondary

Measure	Time frame
Quality of life	12 months
Synchrony by echocardiography	12 months
New York Heart Association (NYHA) class	12
6-minute hall walk test	12

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026