DVT After Cardiac Procedure

NCT03877770 | Completed

• 1 other identifier: 219270
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Thromboembolism; Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Elevation of blood markers of DVT in the absence of clinically detectable DVT.

  Blood sampling takes place pre-ablation and 24 hours post procedure.

• Ultrasound characteristics of the DVT, and change between scans.

  Up to 14 days post procedure.

• The occurrence of DVT in the untreated leg.

  Up to 14 days post procedure.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for elective EP study and catheter ablation.

You may qualify if:

• 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
• sheaths in a femoral vein

You may not qualify if:

• 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

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• Bristol-Myers Squibb: collaborator

Study Sites (5)

Blackpool Teaching Hospitals NHS Foundation Trust

Blackpool, Lancashire, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, Yorkshire, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, M13 9WU, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35301985 DERIVED

MeSH Terms

Conditions

Thromboembolism; Venous Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: March 18, 2019
• Study Start: October 20, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)