Evaluating PVI Using CMR | NCT05437549

Studies
Evaluating PVI Using CMR

NCT05437549

Sponsor

Amsterdam UMC, location VUmc

Status

Unknown status

Last Update Posted

Jun 29, 2022Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Atrial Fibrillation

Interventions

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Estimated

Primary Completion Date

Jan 1, 2024Estimated

Completion Date

Jul 1, 2024Estimated

First Submitted Date

Jun 17, 2022

First Submission Date that Met QC Criteria

Jun 24, 2022

First Posted Date

Jun 29, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2022

Last Update Posted Date

Jun 29, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PVI	Other		Procedure: MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Procedure	MRI prior to PVI, acutely after PVI, and 3 months after PVI	PVI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
AF recurrence	The relation between ablation lesion characteristics and AF recurrence at 1 year after the ablation procedure	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided