Atrial FibrillationSCS-PAFNCT02530203
Spinal Cord Stimulation to Treat Post-operative Atrial Fibrillation
A study testing Spinal Cord Stimulation System and Holter Recording_ NEMon DR220 Holter Recorders in people with Atrial Fibrillation, run by Medtronic BRC at 1 site in Netherlands.
Trial summary
Patients will be randomized to control and spinal cord stimulation arm (SCS) to investigate the effect of SCS on the occurrence of post-operative atrial fibrillation in the five days after surgery. 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?
- Spinal Cord Stimulation System and Holter Recording_ NEMon DR220 Holter Recorders
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2015to Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients which will be subjected to an OFF-pump CABG procedure
- More than 18 years of age
- Subject is able and willing to give informed consent.
Who cannot join
- Patients with known history of atrial arrhythmias.
- Patients who are not treated with β-blockers unless heart rate is too low for β-blockers assumption.
- Participation in another clinical trial which may affect the outcome within 3 months prior to day of procedure.
- Other surgical interventions (e.g. valve replacement) programmed in the same surgical session
- Resting pulse rate ≤45 beats / min as assessed before daily doses of β-blockage is administered.
- Hypotension (RR systolic <100 or RR diastolic <50).
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- Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complete bundle branch block.
- Subject is diagnosed with epilepsy or history of seizures.
- Coagulation abnormalities as determined by anticoagulation guidelines for neuroaxial procedures 2011.
- Patients not stabilized on an anti-arrhythmic drug regimen for the last 30 days.
- Patients with long QT syndrome.
- Patients with Brugada syndrome.
- Patients affected by Polyneuropathy (e.g. due to diabetes).
- Patients affected by pericarditis
- Patients who underwent procedures in the past, which are expected to have changed the innervation of the heart for example:
- Ablation procedure
- Cardiac surgery
- Pregnant patients or nursing (subjects who are of child bearing potential and are not on a reliable form of birth control will undergo a pregnancy test)
- Patients already implanted with cardiac devices
- Patients with existing implanted neurostimulators
Trial locations and contacts
1 site in 1 country.
About this study
Patients will be randomized to control and spinal cord stimulation arm (SCS) to investigate the effect of SCS on the occurrence of post-operative atrial fibrillation in the five days after surgery.
Read the detailed description
Pre market single center clinical research feasibility study. Non blinded randomized controlled study. 52 patients undergoing CABG procedure will be enrolled and randomized into two different group (26 person each): the Spinal Cord Stimulation (SCS) and the control group. The first group will be implanted before the CABG procedure with a temporary SCS lead (5 days) while the second one will not. The lead will be connected to an external stimulator.
The day of the CABG surgery, before the scheduled procedure, the patients in the treatment group will be implanted with the SCS lead. CABG procedure follows the SCS lead implantation. SCS will be switched off before surgery.
After the CABG procedure, all patients will be hospitalized for minimally five days at the end of which they will be discharged. The Primary Endpoint data will be collected from the day of CABG procedure (Day-0) until Day-5. SCS lead will be removed on Day-5.
1-week follow up visit will be performed one week after discharge. End-points will be evaluated at various time before, during and after surgery. In both groups arrhythmic episodes for primary and secondary endpoints will be recorded via a Holter monitor (recording 5 days continuously).
- Conditions
- Atrial Fibrillation
- Being tested
- Spinal Cord Stimulation System, Holter Recording_ NEMon DR220 Holter Recorders
- Keywords
- post-operative atrial fibrillation, spinal cord stimulation, CABG
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord Stimulation SystemDevice
Also called (Medtronic External Neurostimulator Model 37022; Medtronic 1x8 Standard LZ Lead Model 3877; Medtronic MultiLead Trialing Cable MLTC Model 355531)
High frequency stimulation using a catheter placed in the lumen of the spine to inhibit sympathetic outflow to the heart
Holter Recording_ NEMon DR220 Holter RecordersDevice
To measure primary endpoint and most of the secondary endpoints in all the patients enrolled in the study. The recording will start to before CABG procedure and will be stop at day 5.
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment | Other | Non interventional group, patients that belong to this arm will receive the conventional treatment for CABG and they will wear the Holter for 5 days. Receives: Device: Holter Recording_ NEMon DR220 Holter Recorders |
| Spinal Cord Stimulation System | Experimental | This group will receive the Spinal Cord Stimulation System and they will wear the Holter for 5 days. Receives: Device: Spinal Cord Stimulation System; Device: Holter Recording_ NEMon DR220 Holter Recorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation
AT/AF will be defined as an episode with an atrial rate >175 bpm lasting ≥ 20 seconds.
Measured: 5 days after CABG
Secondary outcomes (13)
Medication
Description of integral medication related to AT/AF occurrence and pain in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
Measured: 5 days after CABG
Cardioversion
Description of number of cardioversion needed in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
Measured: 5 days after CABG
Hospitalizations Days
Description of hospitalizations longer than 5 days as required by the protocol and clinical practice in the treatment (SCS) and control group.
Measured: 1 week after discharge
BP
Description of 1) intra arterial blood pressure as averaged over the first 24 hours after surgery and 2) arterial blood pressure as determined using a blood pressure cuff at a specific time on Day-2, Day-3, Day-4 and Day-5 after surgery in the treatment (SCS) and control group.
Measured: 5 days after CABG
Description of the total number of AT/AF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
AT/AF episodes
Measured: 5 days after CABG
Description of burden of AT/AF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
AT/AF burden
Measured: 5 days after CABG
Premature atrial beats
Description of the amount of premature atrial beats in the treatment (SCS) and control group from the end of the procedure till Day-5 after surgery.
Measured: 5 days after CABG
VT/VF episodes
Description of the total number of VT/VF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
Measured: 5 days after CABG
Burden VT/VF episodes
Description of the burden of VT/VF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
Measured: 5 days after CABG
HRV
Improvement LF/HF ratio of Heart Rate Variability (HRV) by SCS. SCS On and Off will be compared in each patients in the treatment (SCS) group before surgery and 5 days after surgery.
Measured: 5 days after CABG
Pain on the VAS scale
Description of pain-score due to CABG surgery measured with a VAS score three times a from Day-1 till Day-5 after surgery in the treatment (SCS) and control group.
Measured: 5 days after CABG
Bladder function
The extra time the bladder catheter will be kept in the patients after the first 2 days after surgery will be described in the treatment (SCS) and control group in order to assess bladder function.
Measured: 5 days after CABG
HR
Description of 1) heart rate as averaged over the first 24 hours after surgery and 2) heart rate as determined using a blood pressure cuff at a specific time on Day-2, Day-3, Day-4 and Day-5 after surgery in the treatment (SCS) and control group.
Measured: 5 days after CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: Due to a change in medication guidelines it became practically impossible to recruit patients
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic BRC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Diephuis, PhD, Principal investigator, Medisch Spectrum Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530203
- Sponsor's protocol ID
- SCS-PAF
- Acronym
- SCS-PAF
- Status last verified
- Apr 2016
- First submitted
- 11 May 2015
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation to Treat Post-operative Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02530203
- Acronym / sponsor ID
- SCS-PAF / SCS-PAF
- Conditions
- Atrial Fibrillation
- Keywords
- post-operative atrial fibrillation, spinal cord stimulation, CABG
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to a change in medication guidelines it became practically impossible to recruit patients
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Medtronic BRCIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 20 Aug 2015 (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.
Patients will be randomized to control and spinal cord stimulation arm (SCS) to investigate the effect of SCS on the occurrence of post-operative atrial fibrillation in the five days after surgery.
Detailed description
Pre market single center clinical research feasibility study. Non blinded randomized controlled study. 52 patients undergoing CABG procedure will be enrolled and randomized into two different group (26 person each): the Spinal Cord Stimulation (SCS) and the control group. The first group will be implanted before the CABG procedure with a temporary SCS lead (5 days) while the second one will not. The lead will be connected to an external stimulator.
The day of the CABG surgery, before the scheduled procedure, the patients in the treatment group will be implanted with the SCS lead. CABG procedure follows the SCS lead implantation. SCS will be switched off before surgery.
After the CABG procedure, all patients will be hospitalized for minimally five days at the end of which they will be discharged. The Primary Endpoint data will be collected from the day of CABG procedure (Day-0) until Day-5. SCS lead will be removed on Day-5.
1-week follow up visit will be performed one week after discharge. End-points will be evaluated at various time before, during and after surgery. In both groups arrhythmic episodes for primary and secondary endpoints will be recorded via a Holter monitor (recording 5 days continuously).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment | Other | Device: Holter Recording_ NEMon DR220 Holter RecordersNon interventional group, patients that belong to this arm will receive the conventional treatment for CABG and they will wear the Holter for 5 days. |
| Spinal Cord Stimulation System | Experimental | Device: Spinal Cord Stimulation System, Device: Holter Recording_ NEMon DR220 Holter RecordersThis group will receive the Spinal Cord Stimulation System and they will wear the Holter for 5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients which will be subjected to an OFF-pump CABG procedure
- More than 18 years of age
- Subject is able and willing to give informed consent.
Key exclusion criteria (20 listed)
- Patients with known history of atrial arrhythmias.
- Patients who are not treated with β-blockers unless heart rate is too low for β-blockers assumption.
- Participation in another clinical trial which may affect the outcome within 3 months prior to day of procedure.
- Other surgical interventions (e.g. valve replacement) programmed in the same surgical session
- Resting pulse rate ≤45 beats / min as assessed before daily doses of β-blockage is administered.
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 |
|---|---|---|
| Spinal Cord Stimulation SystemAlso: (Medtronic External Neurostimulator Model 37022; Medtronic 1x8 Standard LZ Lead Model 3877; Medtronic MultiLead Trialing Cable MLTC Model 355531)High frequency stimulation using a catheter placed in the lumen of the spine to inhibit sympathetic outflow to the heart | Device | Spinal Cord Stimulation System |
| Holter Recording_ NEMon DR220 Holter RecordersTo measure primary endpoint and most of the secondary endpoints in all the patients enrolled in the study. The recording will start to before CABG procedure and will be stop at day 5. | Device | Conventional treatment, Spinal Cord Stimulation System |
Primary outcome
Atrial fibrillation
Time frame: 5 days after CABG
AT/AF will be defined as an episode with an atrial rate >175 bpm lasting ≥ 20 seconds.
13 secondary outcomes
Medication
Time frame: 5 days after CABG
Cardioversion
Time frame: 5 days after CABG
Hospitalizations Days
Time frame: 1 week after discharge
BP
Time frame: 5 days after CABG
Description of the total number of AT/AF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
Time frame: 5 days after CABG
Description of burden of AT/AF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
Time frame: 5 days after CABG
Premature atrial beats
Time frame: 5 days after CABG
VT/VF episodes
Time frame: 5 days after CABG
Burden VT/VF episodes
Time frame: 5 days after CABG
HRV
Time frame: 5 days after CABG
Pain on the VAS scale
Time frame: 5 days after CABG
Bladder function
Time frame: 5 days after CABG
HR
Time frame: 5 days after CABG
Results and safety
The study was stopped early (reason given: Due to a change in medication guidelines it became practically impossible to recruit patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Jan Diephuis, PhD principal investigator
Medisch Spectrum Twente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulation System and Holter Recording_ NEMon DR220 Holter Recorders in people with Atrial Fibrillation, run by Medtronic BRC 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 20 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 6 Apr 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 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 (reason given: Due to a change in medication guidelines it became practically impossible to recruit patients). 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?
Atrial fibrillation (time frame: 5 days after CABG). 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 6 Apr 2016.