Acute and Chronic Effect of His-pacing in Consecutive Patients With AV-block
Primary Purpose
Atrioventricular Block
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Septal pacing
His lead activated
Sponsored by
About this trial
This is an interventional treatment trial for Atrioventricular Block focused on measuring His-pacing
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
Sites / Locations
- Dept. of cardiology Skejby Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Septal pacing
His-pacing
Arm Description
Septal lead will be activated.
His lead will be activated 80 ms before septal lead
Outcomes
Primary Outcome Measures
Left ventricular ejection fraction (LVEF)
Secondary Outcome Measures
Quality of life
Synchrony by echocardiography
New York Heart Association (NYHA) class
6-minute hall walk test
Full Information
NCT ID
NCT01019213
First Posted
November 23, 2009
Last Updated
May 14, 2012
Sponsor
Aarhus University Hospital Skejby
Collaborators
Danish Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01019213
Brief Title
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
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital Skejby
Collaborators
Danish Heart Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrioventricular Block
Keywords
His-pacing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Septal pacing
Arm Type
Placebo Comparator
Arm Description
Septal lead will be activated.
Arm Title
His-pacing
Arm Type
Experimental
Arm Description
His lead will be activated 80 ms before septal lead
Intervention Type
Other
Intervention Name(s)
Septal pacing
Other Intervention Name(s)
Septal lead
Intervention Description
Septal lead activated
Intervention Type
Other
Intervention Name(s)
His lead activated
Other Intervention Name(s)
His lead
Intervention Description
His lead will be activated 80 ms before septal lead
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction (LVEF)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
12 months
Title
Synchrony by echocardiography
Time Frame
12 months
Title
New York Heart Association (NYHA) class
Time Frame
12
Title
6-minute hall walk test
Time Frame
12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torsten T Nielsen, Professor
Organizational Affiliation
Dept. B Skejby Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jens C Nielsen, Phycisian
Organizational Affiliation
Aarhus university Hospital Skajby
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mads B Kronborg, Phycisian
Organizational Affiliation
Aarhus University Hospital Skejby
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of cardiology Skejby Hospital
City
AArhus
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
24509688
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.
Results Reference
derived
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Acute and Chronic Effect of His-pacing in Consecutive Patients With AV-block
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