Evaluating PVI Using CMR

Atrial Fibrillation Clinical Trial

Official title:

CMR Characterization of Ablation Lesions Following Pulmonary Vein Isolation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05437549
• Other study ID #: NL75456.029.20
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: June 2022
• Source: Amsterdam UMC, location VUmc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Using state of the art cardiac magnetic resonance imaging techniques, characterization of ablation lesions in the early phase after pulmonary vein isolation ablation in atrial fibrillation patients, and relate findings to the ablation scar at 3 months follow up and atrial fibrillation-free survival at 1 year.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (age =18 years old)

• Paroxysmal or persistent AF meeting guideline criteria.

• Anticipated PVI using index-guided radiofrequency ablation techniques.

• Availability of LGE-CMR images within 3 months before anticipated PVI.

Exclusion Criteria:

• History of catheter ablation

• History of cardiac surgery.

• History of chest radiation therapy

• Estimated glomerular filtration rate (eGFR) <45 ml/min/kg

• Known (or suspected) allergic reaction to gadolinium

• Contraindications for CMR (such as claustrophobia, certain implants, devices, high body mass index).

• Inability to schedule CMR <48h after PVI

• Long-term use of anti-inflammatory medication, except for the use of nonsteroidal anti-inflammatory drugs

• Autoimmune disease or chronic inflammatory illness.

• Pregnancy of breast feeding

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• MRI
MRI prior to PVI, acutely after PVI, and 3 months after PVI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ablaton scar	The correlation between ablation lesion characteristics in the early phase after PVI and ablation scar at 3 months follow up.	3 months
Secondary	AF recurrence	The relation between ablation lesion characteristics and AF recurrence at 1 year after the ablation procedure	1 year