Deep Vein Thrombosis Clinical Trial
Official title:
Is Deep Vein Thrombosis an Under-recognised Complication of Electrophysiology Procedures? A Mechanistic Observational Study Investigating Markers and Incidence of Thromboembolism
NCT number | NCT03877770 |
Other study ID # | 219270 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 20, 2017 |
Est. completion date | July 31, 2019 |
Verified date | September 2019 |
Source | Manchester University NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 procedure, which may lead to pulmonary embolus which can be life threatening. The study will use Doppler ultrasound scanning at 24h and between 10-14 days post EPS and cardiac ablation to assess the incidence of undiagnosed DVT. A positive finding may provide support for a larger clinical trial to assess the benefit of prophylactic anticoagulation post EPS procedure.
Status | Completed |
Enrollment | 82 |
Est. completion date | July 31, 2019 |
Est. primary completion date | July 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Blackpool Teaching Hospitals NHS Foundation Trust | Blackpool | Lancashire |
United Kingdom | Guy's and St Thomas' NHS Foundation Trust | London | |
United Kingdom | Manchester University NHS Foundation Trust | Manchester | |
United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham | Nottinghamshire |
United Kingdom | Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | Yorkshire |
Lead Sponsor | Collaborator |
---|---|
Manchester University NHS Foundation Trust | Bristol Myers Squibb Pharmaceuticals Limited |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of DVT as evidenced by Doppler Ultrasound | The incidence of DVT in the treated leg will be reported. The study will use Doppler ultrasound scanning post EPS and cardiac ablation to assess the incidence of undiagnosed DVT at up to 14 days post procedure. | Up to 14 days post procedure. | |
Secondary | Elevation of blood markers of DVT in the absence of clinically detectable DVT. | The d-dimer blood sample is taken as part of the research assessment to determine its use as a marker of thrombus formation following invasive procedure.The outcome would be to see if more significant elevation is seen in patients with thrombus and whether a baseline elevated level would put you at higher risk of thrombus. | Blood sampling takes place pre-ablation and 24 hours post procedure. | |
Secondary | Ultrasound characteristics of the DVT, and change between scans. | The study will use Doppler ultrasound scanning post EPS and cardiac ablation to assess the incidence of undiagnosed DVT at up to 14 days post procedure. | Up to 14 days post procedure. | |
Secondary | The occurrence of DVT in the untreated leg. | The DVT incidence in the treated leg will be compared to both that in the control leg and known background incidence from the literature.The study will use Doppler ultrasound scanning post EPS and cardiac ablation to assess the incidence of undiagnosed DVT at up to 14 days post procedure. | Up to 14 days post procedure. |
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