Brady-tachy SyndromeAlternativeNCT00740272
Af Ablation In Brady-Tachy Syndrome
A study testing AF ablation + pacemaker implantation and Pacemaker implantation in people with Brady-tachy Syndrome, run by Abbott Medical Devices at 3 sites in France.
Trial summary
The aim of the study is to evaluate the impact of atrial fibrillation ablation in patients presenting a brady-tachy syndrome on the AF burden. The hypothesis of the study is that AF ablation prevents not only from AF episodes recurrence but also from bradycardic episodes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brady-tachy Syndrome
- What is being tested?
- AF ablation + pacemaker implantation and Pacemaker implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 3 sitesFrance
- Study dates
- Mar 2008to Dec 2009
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- paroxystic AF
- symptomatic pauses (>5s at night or 3s during daytime)
Who cannot join
- permanent AF
- age > 80 y
- pregnant women
- minors
Trial locations and contacts
3 sites in 1 country.
About this study
The aim of the study is to evaluate the impact of atrial fibrillation ablation in patients presenting a brady-tachy syndrome on the AF burden.
The hypothesis of the study is that AF ablation prevents not only from AF episodes recurrence but also from bradycardic episodes.
Read the detailed description
The study is a randomized study 1:1 AF ablation vs non AF ablation. Patients are followed for 1 year. 38 patients will be required to show a significant reduction in AF burden.
- Conditions
- Brady-tachy Syndrome
- Being tested
- AF ablation + pacemaker implantation, Pacemaker implantation
- Keywords
- brady-tachy syndrome, AF ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF ablation + pacemaker implantationProcedure or surgery
regular pacemaker implantation and concomitant AF ablation procedure (PV isolation)
Pacemaker implantationProcedure or surgery
regular pacemaker implantation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AF ablation + pacemaker Receives: Procedure: AF ablation + pacemaker implantation |
| 2 | Active comparator | Pacemaker Receives: Procedure: Pacemaker implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF burden
Measured: 1 year
Secondary outcomes (1)
Quality of life
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brady-tachy SyndromeStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740272
- Sponsor's protocol ID
- SJM-FR01
- Acronym
- Alternative
- Status last verified
- Feb 2019
- First submitted
- 20 Aug 2008
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Af Ablation In Brady-Tachy Syndrome
- ClinicalTrials.gov ID
- NCT00740272
- Acronym / sponsor ID
- Alternative / SJM-FR01
- Conditions
- Brady-tachy Syndrome
- Keywords
- brady-tachy syndrome, AF ablation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 Aug 2008 (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.
The aim of the study is to evaluate the impact of atrial fibrillation ablation in patients presenting a brady-tachy syndrome on the AF burden.
The hypothesis of the study is that AF ablation prevents not only from AF episodes recurrence but also from bradycardic episodes.
Detailed description
The study is a randomized study 1:1 AF ablation vs non AF ablation. Patients are followed for 1 year. 38 patients will be required to show a significant reduction in AF burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: AF ablation + pacemaker implantationAF ablation + pacemaker |
| 2 | Active comparator | Procedure: Pacemaker implantationPacemaker |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- paroxystic AF
- symptomatic pauses (>5s at night or 3s during daytime)
Key exclusion criteria (4 listed)
- permanent AF
- age > 80 y
- pregnant women
- minors
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 |
|---|---|---|
| AF ablation + pacemaker implantationregular pacemaker implantation and concomitant AF ablation procedure (PV isolation) | Procedure or surgery | 1 |
| Pacemaker implantationregular pacemaker implantation | Procedure or surgery | 2 |
Primary outcome
AF burden
Time frame: 1 year
1 secondary outcome
Quality of life
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AF ablation + pacemaker implantation and Pacemaker implantation in people with Brady-tachy Syndrome, run by Abbott Medical Devices at 3 sites in France.
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 2 inclusion and 4 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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 (reason given: Slow recruitment). 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?
AF burden (time frame: 1 year). 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 4 Feb 2019.