Atrioventricular BlockPhase 4NCT01019213
Acute and Chronic Effect of His-pacing in Consecutive Patients With AV-block
A Phase 4 study testing Septal pacing and His lead activated in people with Atrioventricular Block, run by Aarhus University Hospital Skejby at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrioventricular Block
- What is being tested?
- Septal pacing and His lead activated
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2007to Sep 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 2nd or 3rd degree Av block
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Atrioventricular Block
- Being tested
- Septal pacing, His lead activated
- Keywords
- His-pacing
- Medical subject headings
- Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Septal pacingOther
Also called Septal lead
Septal lead activated
His lead activatedOther
Also called His lead
His lead will be activated 80 ms before septal lead
| Study group | Role | What they receive |
|---|---|---|
| Septal pacing | Placebo comparator | Septal lead will be activated. Receives: Other: Septal pacing |
| His-pacing | Experimental | His lead will be activated 80 ms before septal lead Receives: Other: His lead activated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction (LVEF)
Measured: 12 months
Secondary outcomes (4)
Quality of life
Measured: 12 months
Synchrony by echocardiography
Measured: 12 months
New York Heart Association (NYHA) class
Measured: 12
6-minute hall walk test
Measured: 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startSep 2007
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrioventricular BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Heart Foundation
- Responsible party
- Principal investigator, Mads Brix Kronborg, Aarhus University Hospital Skejby
- Investigators
- Torsten T Nielsen, Professor, Study chair, Dept. B Skejby HospitalJens C Nielsen, Phycisian, Study chair, Aarhus university Hospital SkajbyMads B Kronborg, Phycisian, Principal investigator, Aarhus University Hospital Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019213
- Sponsor's protocol ID
- 07-4-B695-A1464-22378
- Status last verified
- May 2012
- First submitted
- 23 Nov 2009
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24509688
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Chronic Effect of His-pacing in Consecutive Patients With AV-block
- ClinicalTrials.gov ID
- NCT01019213
- Acronym / sponsor ID
- 07-4-B695-A1464-22378
- Conditions
- Atrioventricular Block
- Keywords
- His-pacing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Collaborators
- Danish Heart Foundation
- Study start
- Sep 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septal pacing | Placebo comparator | Other: Septal pacingSeptal lead will be activated. |
| His-pacing | Experimental | Other: His lead activatedHis lead will be activated 80 ms before septal lead |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 2nd or 3rd degree Av block
Key exclusion criteria (8 listed)
- QRS > or = 120 ms
- Indication for cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD)
- chronic atrial fibrillation
- Pregnant
- Expected heart surgery < 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Septal pacingAlso: Septal leadSeptal lead activated | Other | Septal pacing |
| His lead activatedAlso: His leadHis lead will be activated 80 ms before septal lead | Other | His-pacing |
Primary outcome
Left ventricular ejection fraction (LVEF)
Time frame: 12 months
4 secondary outcomes
Quality of life
Time frame: 12 months
Synchrony by echocardiography
Time frame: 12 months
New York Heart Association (NYHA) class
Time frame: 12
6-minute hall walk test
Time frame: 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
- Derived from this study: PubMed 24509688Kronborg 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torsten T Nielsen, Professor study chair
Dept. B Skejby Hospital
Jens C Nielsen, Phycisian study chair
Aarhus university Hospital Skajby
Mads B Kronborg, Phycisian principal investigator
Aarhus University Hospital Skejby
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Septal pacing and His lead activated in people with Atrioventricular Block, run by Aarhus University Hospital Skejby at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (LVEF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01019213, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2012.