Atrial FibrillationSOSNCT00528307
Changes in Myocardial Perfusion During Chronic Multi Site Biventricular Versus Right Ventricular Apex Pacing in Patients With Normal Left Ventricular Function Undergoing His Bundle Ablation for Drug-refractory Atrial Fibrillation
A study testing HIS buldle ablation in people with Atrial Fibrillation, run by R&D Cardiologie at 1 site in Netherlands.
Trial summary
To determine whether Biventricular pacing in patients undergoing HIS bundle ablation for atrial fibrilation has beneficial effects on myocardial perfusion and left ventricularr ejection fraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- HIS buldle ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2007to Dec 2010
- Phase
- Interventional
- 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
- Normal to nearly normal LVF (EF > 40%)
- Drug-refractory, persistent or permanent atrial fibrillation
- Referred for His ablation
Who cannot join
- Unwilling or unable to sign the informed consent
- Life expectancy < 1year from non-cardiac causes
- Previous myocardial infarction
- Previous coronary bypass surgery
- Poor left ventricle function (EF< 40%) from any cause
- Symptomatic obstructive coronary artery disease
- Poor ultra sound imaging quality.
Trial locations and contacts
1 site in 1 country.
About this study
To determine whether Biventricular pacing in patients undergoing HIS bundle ablation for atrial fibrilation has beneficial effects on myocardial perfusion and left ventricularr ejection fraction.
- Conditions
- Atrial Fibrillation
- Being tested
- HIS buldle ablation
- Keywords
- myocardial perfusion, His ablation, biventricular pacing, His bundle ablation for atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIS buldle ablationDevice
HIS bundle ablation, followed by implant of a biventricular pacemaker
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | First 3 months of biventricular pacing, second 3 months right ventricular apical pacing Receives: Device: HIS buldle ablation |
| 2 | Active comparator | First 3 months of right ventricular apical pacing, second 3 months biventricular pacing Receives: Device: HIS buldle ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in size of myocardial perfusion abnormalities in the two treatment groups as measured with MPS.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionJul 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- R&D Cardiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincent van Dijk, R&D Cardiologie
- Investigators
- Lucas VA Boersma, MD, PHD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528307
- Sponsor's protocol ID
- RDC-2006-03
- Acronym
- SOS
- Status last verified
- Nov 2014
- First submitted
- 11 Sep 2007
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Myocardial Perfusion During Chronic Multi Site Biventricular Versus Right Ventricular Apex Pacing in Patients With Normal Left Ventricular Function Undergoing His Bundle Ablation for Drug-refractory Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00528307
- Acronym / sponsor ID
- SOS / RDC-2006-03
- Conditions
- Atrial Fibrillation
- Keywords
- myocardial perfusion, His ablation, biventricular pacing, His bundle ablation for atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- R&D CardiologieUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 12 Sep 2007 (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.
To determine whether Biventricular pacing in patients undergoing HIS bundle ablation for atrial fibrilation has beneficial effects on myocardial perfusion and left ventricularr ejection fraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: HIS buldle ablationFirst 3 months of biventricular pacing, second 3 months right ventricular apical pacing |
| 2 | Active comparator | Device: HIS buldle ablationFirst 3 months of right ventricular apical pacing, second 3 months biventricular pacing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Normal to nearly normal LVF (EF > 40%)
- Drug-refractory, persistent or permanent atrial fibrillation
- Referred for His ablation
Key exclusion criteria (7 listed)
- Unwilling or unable to sign the informed consent
- Life expectancy < 1year from non-cardiac causes
- Previous myocardial infarction
- Previous coronary bypass surgery
- Poor left ventricle function (EF< 40%) from any cause
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 |
|---|---|---|
| HIS buldle ablationHIS bundle ablation, followed by implant of a biventricular pacemaker | Device | 1, 2 |
Primary outcome
Difference in size of myocardial perfusion abnormalities in the two treatment groups as measured with MPS.
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
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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.
Lucas VA Boersma, MD, PHD principal investigator
St. Antonius Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIS buldle ablation in people with Atrial Fibrillation, run by R&D Cardiologie at 1 site in Netherlands.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 5 Nov 2014. 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 Netherlands. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Difference in size of myocardial perfusion abnormalities in the two treatment groups as measured with MPS. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2014; AzTrials last refreshed its copy on 30 Oct 2026.