Status:
COMPLETED
DVT After Cardiac Procedure
Lead Sponsor:
Manchester University NHS Foundation Trust
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Thromboembolism
Deep Vein Thrombosis
Eligibility:
All Genders
18-80 years
Brief Summary
Patients undergoing electrophysiology studies (EPS) and cardiac ablation procedure for the treatment of cardiac arrhythmias may be at increased risk of deep vein thrombosis (DVT) during or after the p...
Detailed Description
Electrophysiological study (EPS) and catheter ablation is an established method for the assessment and treatment of many patients with cardiac arrhythmias (altered heart rhythm). It is generally carri...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients aged 18 - 80 undergoing elective EP study and catheter ablation
- Procedure duration between 30 minutes - 4 hours from the time of venous puncture to sheath removal
- 3-5 sheaths in a femoral vein
- Exclusion Criteria (pre-procedure):
- Under 18
- Electrophysiology study only (no ablation performed)
- Inadequate understanding of spoken English
- Intubated/ventilated patients
- Unwilling to give consent to participation OR advised by consultee that this would be against the patient's wishes.
- Recently treated infection
- Intravascular implanted cardiac device
- Prior pacemaker extraction
- Prior cardiac surgery
- Previous cardiac ablation within 6 months
- Documented atrial flutter or atrial fibrillation within 1 year prior to ablation procedure.
- Participation in a clinical trial of an investigational medicinal product (CTIMP)
- Documented previous venous thrombosis or pulmonary embolism
- Known coagulopathy or anticoagulant use
- Known use of anti-platelet agent
- Known concurrent clinical problem likely to interfere with participation or completion of the study
- Exclusion criteria (post-procedure):
- EPS carried out without ablation
- Left sided ablation or other clinical mandate for perioperative anticoagulation
- Complications during procedure (including arterial puncture or failure to advance venous wires)
- Peri-procedural complications that would, in the opinion of the PI/designee preclude further participation in the study
- Post-procedure bleeding or haematoma formation requiring prolonged (\>30 minutes) pressure
Exclusion
Key Trial Info
Start Date :
October 20 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT03877770
Start Date
October 20 2017
End Date
July 31 2019
Last Update
February 5 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, Lancashire, United Kingdom
2
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom
3
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, Yorkshire, United Kingdom
4
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom