Clinical trial NCT01019213: Acute and Chronic Effect of His-pacing in Consecutive Patients With AV-block
Official title: Acute and Chronic Effect of His-pacing in Consecutive Patients With AV-block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrioventricular Block
Keywords: His-pacing
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Danish Heart Foundation
First posted: 2009-11-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Left ventricular ejection fraction (LVEF)
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life
timeFrame: 12 months
measure: Synchrony by echocardiography
timeFrame: 12 months
measure: New York Heart Association (NYHA) class
timeFrame: 12
measure: 6-minute hall walk test
timeFrame: 12
Other outcomes:
Locations:
city: AArhus
country: Denmark
facility: Dept. of cardiology Skejby Hospital
Study officials:
affiliation: Dept. B Skejby Hospital
name: Torsten T Nielsen, Professor
role: STUDY_CHAIR
affiliation: Aarhus university Hospital Skajby
name: Jens C Nielsen, Phycisian
role: STUDY_CHAIR
affiliation: Aarhus University Hospital Skejby
name: Mads B Kronborg, Phycisian
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.