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| Name | Class |
|---|---|
| Danish Heart Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Septal pacing | Placebo Comparator | Septal lead will be activated. |
|
| His-pacing | Experimental | His lead will be activated 80 ms before septal lead |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Septal pacing | Other | Septal lead activated |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular ejection fraction (LVEF) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | 12 months | |
| Synchrony by echocardiography | 12 months | |
| New York Heart Association (NYHA) class |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of cardiology Skejby Hospital | Aarhus | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24509688 | Derived | 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. |
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| ID | Term |
|---|---|
| D054537 | Atrioventricular Block |
| ID | Term |
|---|---|
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| His lead activated | Other | His lead will be activated 80 ms before septal lead |
|
|
| 12 |
| 6-minute hall walk test | 12 |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |