Spinal Cord Stimulation to Treat Post-operative Atrial Fibrillation
NCT ID: NCT02530203
Last Updated: 2016-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
4 participants
INTERVENTIONAL
2015-02-28
2016-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men
NCT06200311
Atrial Fibrillation Ablation and Autonomic Modulation Via Thorascopic Surgery
NCT01091389
TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery
NCT03539354
Inhibition of Atrial Fibrillation by Elimination of Transitional Mechanisms
NCT02758002
Clinical Investigation to Determine the Accuracy and Benefit of Cardioskin™ in Patients With Known Atrial Fibrillation
NCT03964025
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Conventional treatment
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.
Holter Recording_ NEMon DR220 Holter Recorders
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.
Spinal Cord Stimulation System
This group will receive the Spinal Cord Stimulation System and they will wear the Holter for 5 days.
Spinal Cord Stimulation System
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 Recorders
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Spinal Cord Stimulation System
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 Recorders
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. More than 18 years of age
3. Subject is able and willing to give informed consent.
Exclusion Criteria
2. Patients who are not treated with β-blockers unless heart rate is too low for β-blockers assumption.
3. Participation in another clinical trial which may affect the outcome within 3 months prior to day of procedure.
4. Other surgical interventions (e.g. valve replacement) programmed in the same surgical session
5. Resting pulse rate ≤45 beats / min as assessed before daily doses of β-blockage is administered.
6. Hypotension (RR systolic \<100 or RR diastolic \<50).
7. Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complete bundle branch block.
8. Subject is diagnosed with epilepsy or history of seizures.
9. Coagulation abnormalities as determined by anticoagulation guidelines for neuroaxial procedures 2011.
10. Patients not stabilized on an anti-arrhythmic drug regimen for the last 30 days.
11. Patients with long QT syndrome.
12. Patients with Brugada syndrome.
13. Patients affected by Polyneuropathy (e.g. due to diabetes).
14. Patients affected by pericarditis
15. Patients who underwent procedures in the past, which are expected to have changed the innervation of the heart for example:
* Ablation procedure
* Cardiac surgery
16. 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)
17. Patients already implanted with cardiac devices
18. Patients with existing implanted neurostimulators
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic BRC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jan Diephuis, PhD
Role: PRINCIPAL_INVESTIGATOR
Medisch Spectrum Twente
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medisch Spectrum Twente (MST)
Enschede, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SCS-PAF
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.