Paroxysmal Atrial FibrillationNCT03242941
AF Septal Pacing (Clinical Investigation Plan)
A study testing Pulmonary vein ablation in people with Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Medtronic BRC at 3 sites in 2 countries.
Trial summary
The purpose of this non-randomized, non-controlled, acute, single-arm research study is to evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on the interatrial septum. The possibility to terminate atrial arrythmias will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- What is being tested?
- Pulmonary vein ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 26 Apr 2018to 21 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient referred to the center to undergo ablation of the pulmonary vein using radiofrequency (initial AF ablation, or redo procedure).
- In case of paroxysmal AF the right atrium should be dilated as indicated by > 29 ml mm2 or the left atrium should be dilated as indicated by > 34 ml mm2.
- Patient is willing and able to cooperate with the study procedure.
- Patient is willing to provide the Informed Consent for their participation in the study.
Who cannot join
- Patients under 18 years or over 80 years old.
- Women who are currently pregnant or have a positive pregnancy test.
- Patients with an implantable cardiac device.
- Patients who already underwent an AF septal ablation procedure.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Netherlands2 sites
Maastricht Universitair Medisch Centrum (MUMC)
Maastricht, 6229 HX
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM
About this study
The purpose of this non-randomized, non-controlled, acute, single-arm research study is to evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on the interatrial septum. The possibility to terminate atrial arrythmias will also be evaluated.
Read the detailed description
The evidence of treating AF by pacing is limited, although these algorithms are of interest, since they appear to be safe and usually add little additional cost.
Using a computer model, a new dual-stage septal pacing has been developed.The proposed septal pacing algorithm could suppress AF reentries in a more robust way than classical single site rapid pacing. The feasibility of pacing both atria simultaneously from a single lead placed in the interatrial septum has been previously demonstrated clinically. The septal pacing concept has also been successfully tested in a computer model of AF and in a pig model . Experimental studies are now needed to determine whether similar termination mechanisms and efficacies can be observed in humans.
The purpose of this non-randomized, non-controlled, acute, single-arm research study is to evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on the interatrial septum
- Being tested
- Pulmonary vein ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein ablationProcedure or surgery
After pulmonary vein isolation, during the routine waiting time of half an hour to confirm efficacy of the ablation, the septal catheter, already in place in right atrium, will be positioned on the interatrial septum. If the patient will not be in sinus rhythm, he/she will be externally cardioverted in order to determine pacing thresholds and impedances on all septal catheter electrodes. Next, atrial fibrillation will be induced by rapid atrial pacing.AF cycle length will be determined in the left atrial appendage, during 1 minute of atrial fibrillation using ablation catheter electrodes. Subsequently, a pacing scheme will be applied and capture on decapolar recording catheters, already in place for the standard ablation procedure will be assessed as well as AF termination.
| Study group | Role | What they receive |
|---|---|---|
| Persistent and Paroxtmal AF Patients | Experimental | Patients with either paroxymal or persistent AF already referred to the center for Pulmonary Vein Ablation will be stimulated delivering a novel dual-stage pacing protocol to terminate atrial fibrillation usinf a ring of electrodes positioned on the septum. Receives: Procedure: Pulmonary vein ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Electrodes in a Stable Position
To assess Pacing Site Stability, the number of interatrial septal pacing electrodes which are successfully placed in a stable position, will be counted. A stable position in this study is defined as a location where the pacing threshold will be < 10 mA at a pacing pulse width of 1 msec. Stable pacing further requires that no ventricular capture will be induced during atrial stimulation at twice the atrial capture threshold.
Measured: 30 minutes
Secondary outcomes (2)
Localized Atrial Capture
To assess Localized Atrial Capture the following endpoints will be considered:
- the number of AF episodes in which local capture is recorded during atrial septal stimulation in at least one of the electrode positions
Measured: 30 minutes
Termination of Atrial Tachyarrhythmia.
Termination of atrial tachyarrhythmia.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start26 Apr 2018
- Primary completion20 Jul 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Paroxysmal 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
- Not applicable
- Intervention model
- Single group
- Model description
- Approximately 15 subjects with AF indicated for ablation of the pulmonary vein will be enrolled in the study. Participants will attend the Baseline visit and the Procedure visit. The baseline visit can be on the same day as the ablation procedure. Since it is an acute study, no follow-up visit will occur. The research procedure will be performed during an already scheduled ablation procedure. Subjects will be enrolled over a period of approximately 18 months
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic BRC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lucas V.A. Boersma, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242941
- Sponsor's protocol ID
- AF Septal Pacing
- Status last verified
- Oct 2019
- First submitted
- 4 Aug 2017
- Last updated
- 4 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AF Septal Pacing (Clinical Investigation Plan)
- ClinicalTrials.gov ID
- NCT03242941
- Acronym / sponsor ID
- AF Septal Pacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medtronic BRCIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 8 Aug 2017 (actual)
- Results
- Posted 20 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this non-randomized, non-controlled, acute, single-arm research study is to evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on the interatrial septum. The possibility to terminate atrial arrythmias will also be evaluated.
Detailed description
The evidence of treating AF by pacing is limited, although these algorithms are of interest, since they appear to be safe and usually add little additional cost.
Using a computer model, a new dual-stage septal pacing has been developed.The proposed septal pacing algorithm could suppress AF reentries in a more robust way than classical single site rapid pacing. The feasibility of pacing both atria simultaneously from a single lead placed in the interatrial septum has been previously demonstrated clinically. The septal pacing concept has also been successfully tested in a computer model of AF and in a pig model . Experimental studies are now needed to determine whether similar termination mechanisms and efficacies can be observed in humans.
The purpose of this non-randomized, non-controlled, acute, single-arm research study is to evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on the interatrial septum
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Approximately 15 subjects with AF indicated for ablation of the pulmonary vein will be enrolled in the study. Participants will attend the Baseline visit and the Procedure visit. The baseline visit can be on the same day as the ablation procedure. Since it is an acute study, no follow-up visit will occur. The research procedure will be performed during an already scheduled ablation procedure. Subjects will be enrolled over a period of approximately 18 months
| Arm | Type | Receives |
|---|---|---|
| Persistent and Paroxtmal AF Patients | Experimental | Procedure: Pulmonary vein ablationPatients with either paroxymal or persistent AF already referred to the center for Pulmonary Vein Ablation will be stimulated delivering a novel dual-stage pacing protocol to terminate atrial fibrillation usinf a ring of electrodes positioned on the septum. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient referred to the center to undergo ablation of the pulmonary vein using radiofrequency (initial AF ablation, or redo procedure).
- In case of paroxysmal AF the right atrium should be dilated as indicated by > 29 ml mm2 or the left atrium should be dilated as indicated by > 34 ml mm2.
- Patient is willing and able to cooperate with the study procedure.
- Patient is willing to provide the Informed Consent for their participation in the study.
Key exclusion criteria (4 listed)
- Patients under 18 years or over 80 years old.
- Women who are currently pregnant or have a positive pregnancy test.
- Patients with an implantable cardiac device.
- Patients who already underwent an AF septal ablation procedure.
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 |
|---|---|---|
| Pulmonary vein ablationAfter pulmonary vein isolation, during the routine waiting time of half an hour to confirm efficacy of the ablation, the septal catheter, already in place in right atrium, will be positioned on the interatrial septum. If the patient will not be in sinus rhythm, he/she will be externally cardioverted in order to determine pacing thresholds and impedances on all septal catheter electrodes. Next, atrial fibrillation will be induced by rapid atrial pacing.AF cycle length will be determined in the left atrial appendage, during 1 minute of atrial fibrillation using ablation catheter electrodes. Subsequently, a pacing scheme will be applied and capture on decapolar recording catheters, already in place for the standard ablation procedure will be assessed as well as AF termination. | Procedure or surgery | Persistent and Paroxtmal AF Patients |
Primary outcome
Number of Electrodes in a Stable Position
Time frame: 30 minutes
To assess Pacing Site Stability, the number of interatrial septal pacing electrodes which are successfully placed in a stable position, will be counted. A stable position in this study is defined as a location where the pacing threshold will be < 10 mA at a pacing pulse width of 1 msec. Stable pacing further requires that no ventricular capture will be induced during atrial stimulation at twice the atrial capture threshold.
2 secondary outcomes
Localized Atrial Capture
Time frame: 30 minutes
Termination of Atrial Tachyarrhythmia.
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 V.A. Boersma principal investigator
St. Antonius Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary vein ablation in people with Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Medtronic BRC at 3 sites in 2 countries.
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 4 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: finished, as of the sponsor's last update on 4 Nov 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 Netherlands, Hungary. 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?
Yes. Results are posted in the registry (first posted 20 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Electrodes in a Stable Position (time frame: 30 minutes). 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 Nov 2019.