Atrial FibrillationNCT02269774
Origin of Premature Atrial Beats Induced by Simulated Obstructive Sleep Apnea
A study testing Standard pulmonary vein isolation in people with Atrial Fibrillation and Sleep Apnea, Obstructive, run by University of Zurich at 1 site in Switzerland.
Trial summary
There is accumulating evidence for obstructive sleep apnea (OSA) as an independent risk factor for paroxysmal atrial fibrillation and for high recurrence rates of atrial fibrillation after ablation therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Sleep Apnea, Obstructive, Atrial Premature Complexes
- What is being tested?
- Standard pulmonary vein isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2014to Jan 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of ECG-documented paroxysmal atrial fibrillation within the last 12 months and currently in sinus rhythm
- Scheduled for circumferential pulmonary venous isolation treatment
- 18 to 75 years of age
- Signed informed consent
Who cannot join
- Treated with class III anti-arrhythmic agents (at the moment of pulmonary venous isolation)
- Treated for obstructive sleep apnea
- Previous catheter ablation in the pulmonary veins or left atrium
- Severe structural heart disease
- Mental or physical disability precluding informed consent or compliance with the protocol
- Enrolled in another study that would confound the results of this trial
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Electroanatomic Origin of Premature Atrial Beats in Patients With Paroxysmal Atrial Fibrillation Induced by Intra-thoracic Pressure Swings Simulating Obstructive Sleep Apnea
There is accumulating evidence for obstructive sleep apnea (OSA) as an independent risk factor for paroxysmal atrial fibrillation and for high recurrence rates of atrial fibrillation after ablation therapy. We have previously shown that simulated OSA triggers premature atrial beats (PABs) by acute changes in intra-thoracic pressure. Most episodes of atrial fibrillation are initiated by PABs. However, the origin of PABs induced by intra-thoracic pressure swings is unknown. This study investigates the origin of premature atrial beats induced by intra-thoracic pressure changes that simulate obstructive sleep apnea in patients with atrial fibrillation.
- Being tested
- Standard pulmonary vein isolation
- Keywords
- Atrial Fibrillation, Obstructive Sleep Apnea, Atrial Premature Complexes, Pulmonary Vein Isolation, Mueller Manoeuvre
- Medical subject headings
- Atrial Fibrillation, Sleep Apnea, Obstructive, Atrial Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard pulmonary vein isolationProcedure or surgery
The MM will be carried out during a elective standard pulmonary vein isolation procedure. The MM will be performed using an occluded mouthpiece with a small air leak to prevent complete closure of the glottis during inspiration and thus assure negative pressure throughout the entire airway. After expiration, inspiration with a target negative intrathoracic pressure of -40mmHg will be carried out against the mouthpiece.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary vein isolation | Other | Intra-thoracic pressure swings induced by breathing manoeuvres during standard catheter-ablation procedure. Catheter-based electrical mapping and pressure in the left atrium and pulmonary veins during standard catheter-ablation procedure. Only patients with an apnea-hypopnea index > 5/h and documented premature atrial beats during the Mueller manoeuvre will be eligible for the catheter-based electrical mapping. Follow-up after 1 year for atrial fibrillation recurrence. Receives: Procedure: Standard pulmonary vein isolation |
| No intevention | No intervention | Intra-thoracic pressure swings induced by breathing manoeuvres during ECG-monitoring. Only patients with an apnea-hypopnea index < 5/h and no premature atrial beats during the Mueller manoeuvre will be assigned to the no intervention arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroanatomical origin of premature atrial beats
(Loop-)Catheter-based origin detection in patients with apnea-hypopnea index > 5/h in home sleep study and documented premature atrial beats during three time points: baseline (normal breathing), inspiration through a threshold load device, and the Mueller Manoeuvre (MM). Origins will be quantitatively marked at a left atrial map.
Measured: Participants will be followed for the duration of pulmonary vein isolation, an expected average of 3 hours
Secondary outcomes (1)
Catheter-based pressure in the left atrium and pulmonary veins during intra-thoracic pressure changes
Catheter-based left atrial pressure measurement in patients with apnea-hypopnea index > 5/h in home sleep study and documented premature atrial beats during three time points: baseline (normal breathing), inspiration through a threshold load device, and the Mueller Manoeuvre. Changes in left atrial pressure will be recorded in cmH2O.
Measured: Participants will be followed for the duration of pulmonary vein isolation, an expected average of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Due to the strict in- and exclusion criteria only few patients could be enrolled into the study.
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.
- More trials run by University of ZurichThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malcolm Kohler, University of Zurich
- Investigators
- Malcolm Kohler, MD, Prof, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269774
- Sponsor's protocol ID
- KEK-ZH-Nr. 2014-0203
- Status last verified
- Oct 2016
- First submitted
- 14 Oct 2014
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroanatomic Origin of Premature Atrial Beats in Patients With Paroxysmal Atrial Fibrillation Induced by Intra-thoracic Pressure Swings Simulating Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02269774
- Acronym / sponsor ID
- KEK-ZH-Nr. 2014-0203
- Keywords
- Atrial Fibrillation, Obstructive Sleep Apnea, Atrial Premature Complexes, Pulmonary Vein Isolation, Mueller Manoeuvre
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the strict in- and exclusion criteria only few patients could be enrolled into the study.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 Oct 2014 (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.
There is accumulating evidence for obstructive sleep apnea (OSA) as an independent risk factor for paroxysmal atrial fibrillation and for high recurrence rates of atrial fibrillation after ablation therapy. We have previously shown that simulated OSA triggers premature atrial beats (PABs) by acute changes in intra-thoracic pressure. Most episodes of atrial fibrillation are initiated by PABs. However, the origin of PABs induced by intra-thoracic pressure swings is unknown. This study investigates the origin of premature atrial beats induced by intra-thoracic pressure changes that simulate obstructive sleep apnea in patients with atrial fibrillation.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary vein isolation | Other | Procedure: Standard pulmonary vein isolationIntra-thoracic pressure swings induced by breathing manoeuvres during standard catheter-ablation procedure. Catheter-based electrical mapping and pressure in the left atrium and pulmonary veins during standard catheter-ablation procedure. Only patients with an apnea-hypopnea index > 5/h and documented premature atrial beats during the Mueller manoeuvre will be eligible for the catheter-based electrical mapping. Follow-up after 1 year for atrial fibrillation recurrence. |
| No intevention | No intervention | –Intra-thoracic pressure swings induced by breathing manoeuvres during ECG-monitoring. Only patients with an apnea-hypopnea index < 5/h and no premature atrial beats during the Mueller manoeuvre will be assigned to the no intervention arm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of ECG-documented paroxysmal atrial fibrillation within the last 12 months and currently in sinus rhythm
- Scheduled for circumferential pulmonary venous isolation treatment
- 18 to 75 years of age
- Signed informed consent
Key exclusion criteria (6 listed)
- Treated with class III anti-arrhythmic agents (at the moment of pulmonary venous isolation)
- Treated for obstructive sleep apnea
- Previous catheter ablation in the pulmonary veins or left atrium
- Severe structural heart disease
- Mental or physical disability precluding informed consent or compliance with the protocol
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 |
|---|---|---|
| Standard pulmonary vein isolationThe MM will be carried out during a elective standard pulmonary vein isolation procedure. The MM will be performed using an occluded mouthpiece with a small air leak to prevent complete closure of the glottis during inspiration and thus assure negative pressure throughout the entire airway. After expiration, inspiration with a target negative intrathoracic pressure of -40mmHg will be carried out against the mouthpiece. | Procedure or surgery | Pulmonary vein isolation |
Primary outcome
Electroanatomical origin of premature atrial beats
Time frame: Participants will be followed for the duration of pulmonary vein isolation, an expected average of 3 hours
(Loop-)Catheter-based origin detection in patients with apnea-hypopnea index > 5/h in home sleep study and documented premature atrial beats during three time points: baseline (normal breathing), inspiration through a threshold load device, and the Mueller Manoeuvre (MM). Origins will be quantitatively marked at a left atrial map.
1 secondary outcome
Catheter-based pressure in the left atrium and pulmonary veins during intra-thoracic pressure changes
Time frame: Participants will be followed for the duration of pulmonary vein isolation, an expected average of 3 hours
Results and safety
The study was stopped early (reason given: Due to the strict in- and exclusion criteria only few patients could be enrolled into the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
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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.
Malcolm Kohler, MD, Prof principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard pulmonary vein isolation in people with Atrial Fibrillation and Sleep Apnea, Obstructive, run by University of Zurich at 1 site in Switzerland.
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 6 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 25 Oct 2016. 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 Switzerland. 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: Due to the strict in- and exclusion criteria only few patients could be enrolled into the study.). 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?
Electroanatomical origin of premature atrial beats (time frame: Participants will be followed for the duration of pulmonary vein isolation, an expected average of 3 hours). 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 25 Oct 2016.