Personalized Treatment for Patients With Premature Ventricular Beats

Ventricular Premature Complexes Clinical Trial

Official title:

Personalized Treatment for Patients With Premature Ventricular Beats

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04617717
• Other study ID #: 153850
• Status: Recruiting
• Start date: September 30, 2020
• Est. completion date: July 31, 2040

Study information

• Verified date: October 2023
• Source: Oslo University Hospital
• Contact: Mathis K Stokke, MD PhD
• Phone: 90696883
• Email: m.k.stokke[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Frequent premature ventricular beats (PVBs) are common, negatively affects the quality of life for many patients, and can lead to impaired contractile function. Rule-out of structural heart disease is key in the assessment of PVBs. Cardiac MR has a high sensitivity for structural heart disease, but the diagnostic gain from this resource-demanding procedure in the work-up of patients with PVBs is unknown. There is a need to establish the role of MR in the evaluation of patients with PVBs to improve diagnostic efficacy, establish treatment strategies, and promote further research. This project will answer three key questions: 1) What is the diagnostic gain from cardiac MR in patients with PVBs? 2) Is MR the real gold standard to rule-out structural heart disease in patients with PVBs? 3) Can non-invasive heart rate parameters guide the strategy for induction of PVBs during invasive electrophysiological procedures?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: July 31, 2040
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years
• Eligibility: Inclusion Criteria: Patients referred for PVC ablation

Related Conditions & MeSH terms

• Premature Birth
• Ventricular Premature Complexes

Intervention

Procedure:
• Invasive cardiac electrophysiological study and ablation therapy
Invasive cardiac electrophysiological study with cathecholamine provocation and pacing procedures, as well as standard 3D mapping and PVC ablation

Diagnostic Test:
• Cardiopulmonary exercise testing
Standard ergometer bicycle test
• Cardiac MRI
Cardiac MRI with cine-imaging and late-gadolinium enhancement
• Holter monitoring
24h 5 lead or 12 lead ECG recording
• Transthoracic echocardiography
2D echocardiography
• Coronary angiography
Conventional invasive coronary angiography or CT angiography as indicated

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI-based evidence of structural heart disease	Evidence of structural heart disease from MRI compared to echocardiography	3-5 years
Primary	PVC induction vs PVC/HR-relationship	Correlation of method for induction of PVCs during invasive procedure vs PVC/HR relationship during CPET	3-5 years
Primary	EPS-based evidence of structural heart disease	Evidence of structural heart disease from invasive electrophysiology vs MRI and echo	3-5 years