ThromboembolismNCT03877770
DVT After Cardiac Procedure
An observational study of Thromboembolism and Deep Vein Thrombosis, run by Manchester University NHS Foundation Trust at 5 sites in United Kingdom.
Trial 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 procedure, which may lead to pulmonary embolus which can be life threatening. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thromboembolism, Deep Vein Thrombosis
- How many people
- 82 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 20 Oct 2017to 31 Jul 2019
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for elective EP study and catheter ablation.
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, Lancashire
Guy's and St Thomas' NHS Foundation Trust
London
Manchester University NHS Foundation Trust
Manchester, M13 9WU
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, Yorkshire
About this study
Official title: Is Deep Vein Thrombosis an Under-recognised Complication of Electrophysiology Procedures? A Mechanistic Observational Study Investigating Markers and Incidence of Thromboembolism
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.
Read the 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 carried out in patients who are usually otherwise fairly fit and healthy. In the UK many patients undergo this procedure and the numbers are increasing. The procedure involves a number of catheters (tubes) being inserted into the femoral vein over a period of up to 2 ½ hours. Presence of the catheter in the vein increases the risk of blood clot formation, if a clot blocks a deep vein in the leg (deep vein thrombosis), it can lead to pain and chronic leg swelling as well as the need for blood thinning (anticoagulant) medications. In some patients, fragments of the blood clot can break off and travel to the lungs which can be life-threatening. It is important to detect the presence of a clot as soon as possible, so that treatment may be given. The investigators hope to establish if the condition is more common than originally thought.
The investigators plan to recruit 100 patients who are due to undergo EPS or catheter ablation. Prior to the participant's clinical procedure, the investigators will perform an additional blood test to check blood clotting function. After the cardiac procedure, the participants will then undergo Doppler ultrasound scans at 24 hours and a second scan between 10-14 days to check for the presence of blood clots.
The aim of the study is to increase understanding of how often these blood clots occur and confirm if blood tests or current gold-standard imaging is best at showing the early stages of blood clot formation. The results of the study will help decide if a clinical trial is needed to test whether giving preventative blood thinning treatment after cardiac procedures would be beneficial.
- Conditions
- Thromboembolism, Deep Vein Thrombosis
- Medical subject headings
- Thromboembolism, Venous Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 14 days post procedure.
Secondary outcomes (3)
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.
Measured: Blood sampling takes place pre-ablation and 24 hours post procedure.
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.
Measured: Up to 14 days post procedure.
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.
Measured: Up to 14 days post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start20 Oct 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThromboembolismStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877770
- Sponsor's protocol ID
- 219270
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2019
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bruce C, Saraf K, Rogers S, El-Omar M, Kirkwood G, Kelland NF, Shah D, Chalil S, Fullwood C, Wright M, Jamil-Copley S, Fox D, Abozguia K, Thachil J, McCollum C, Morris GM. Deep Vein Thrombosis is Common After Cardiac Ablation and Pre-Procedural D-Dimer Could Predict Risk. Heart Lung Circ. 2022 Jul;31(7):1015-1022. doi: 10.1016/j.hlc.2022.01.014. Epub 2022 Mar 14.
PubMed 35301985
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Deep Vein Thrombosis an Under-recognised Complication of Electrophysiology Procedures? A Mechanistic Observational Study Investigating Markers and Incidence of Thromboembolism
- ClinicalTrials.gov ID
- NCT03877770
- Acronym / sponsor ID
- 219270
- Conditions
- Thromboembolism, Deep Vein Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- Bristol-Myers Squibb
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 18 Mar 2019 (actual)
- 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 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.
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 carried out in patients who are usually otherwise fairly fit and healthy. In the UK many patients undergo this procedure and the numbers are increasing. The procedure involves a number of catheters (tubes) being inserted into the femoral vein over a period of up to 2 ½ hours. Presence of the catheter in the vein increases the risk of blood clot formation, if a clot blocks a deep vein in the leg (deep vein thrombosis), it can lead to pain and chronic leg swelling as well as the need for blood thinning (anticoagulant) medications. In some patients, fragments of the blood clot can break off and travel to the lungs which can be life-threatening. It is important to detect the presence of a clot as soon as possible, so that treatment may be given. The investigators hope to establish if the condition is more common than originally thought.
The investigators plan to recruit 100 patients who are due to undergo EPS or catheter ablation. Prior to the participant's clinical procedure, the investigators will perform an additional blood test to check blood clotting function. After the cardiac procedure, the participants will then undergo Doppler ultrasound scans at 24 hours and a second scan between 10-14 days to check for the presence of blood clots.
The aim of the study is to increase understanding of how often these blood clots occur and confirm if blood tests or current gold-standard imaging is best at showing the early stages of blood clot formation. The results of the study will help decide if a clinical trial is needed to test whether giving preventative blood thinning treatment after cardiac procedures would be beneficial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for elective EP study and catheter ablation.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of DVT as evidenced by Doppler Ultrasound
Time frame: Up to 14 days post procedure.
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.
3 secondary outcomes
Elevation of blood markers of DVT in the absence of clinically detectable DVT.
Time frame: Blood sampling takes place pre-ablation and 24 hours post procedure.
Ultrasound characteristics of the DVT, and change between scans.
Time frame: Up to 14 days post procedure.
The occurrence of DVT in the untreated leg.
Time frame: Up to 14 days post procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Derived from this study: PubMed 35301985Bruce C, Saraf K, Rogers S, El-Omar M, Kirkwood G, Kelland NF, Shah D, Chalil S, Fullwood C, Wright M, Jamil-Copley S, Fox D, Abozguia K, Thachil J, McCollum C, Morris GM. Deep Vein Thrombosis is Common After Cardiac Ablation and Pre-Procedural D-Dimer Could Predict Risk. Heart Lung Circ. 2022 Jul;31(7):1015-1022. doi: 10.1016/j.hlc.2022.01.014. Epub 2022 Mar 14.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thromboembolism and Deep Vein Thrombosis, run by Manchester University NHS Foundation Trust at 5 sites in United Kingdom.
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 21 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: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Presence of DVT as evidenced by Doppler Ultrasound (time frame: Up to 14 days post procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03877770, which also lists 1 linked publication.
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 5 Feb 2025.