Back to resultsUnivu-guided Vein of Marshall Ethanol Infusion (Marshall-Merge)
Primary Purpose
Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Vein of Marshall ethanol infusion
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria: Age between 18 and 85 years Sympathetic atrial fibrillation without previous ablation Persistent or long-standing persistent AF Patients' willing to undergo catheter ablation and VOMEI Exclusion Criteria: Left atrial or left atrial appendage thrombus LVEF <30% Cardiac surgery within 90 days Myocardial infarction within 90 days PCI or PTCA within 90 days Thromboembolic events within 90 days, including stroke, pulmonary embolism, systemic embolism Atrial myxoma Congenital heart disease Pregnant or pregnant plan Acute or severe infection Creatine> 221 μmol/L, or GFR <30 ml/min/1.73 m. Unstable angina Blood-clotting or bleeding disorder Contraindication to anticoagulation Life expectancy less than 1 year Uncontrolled heart failure Uncontrolled malignant tumor Malformation of femoral vascular access Without consent
Sites / Locations
- Xinhua hospital, Shanghai Jiao Tong University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Fluoroscopy-guided VOMEI
UNIVU-guided VOMEI
Arm Description
Vein of Marshall ethanol infusion guided by fluoroscopy alone
Vein of Marshall ethanol infusion guided by CARTO UNIVU and fluoroscopy
Outcomes
Primary Outcome Measures
Changes of low-voltage or scar area before and after VOMEI
Left atrial voltage mapping will be performed before and after VOMEI. The low-voltage area or scar area will be mesured and compared before and after VOMEI
Procedural complications
Including cardiac tamponade, stroke, systemic embolism, major bleeding, acute coronary syndrome, acute heart failure, and death.
Recurrence of atrial tachyarrhythmias
Including recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia
Secondary Outcome Measures
Rates of mitral isthmus block
bidirectional block of mitral isthmus
New low-voltage or scar area outside mitral isthmus and left pulmonary ridge
New low-voltage or scar area after VOMEI outside the targeted regions
Rates of VOMEI incomplete
Any reason leading to incomplete VOMEI
X ray exposure time
Procedure-related temporal parameters
procedure time
Procedure-related temporal parameters
radiofrequency ablation time
Procedure-related temporal parameters
Rates of intraprocedural termination of atrial fibrillation (not achieved by cardioversion)
Termination of atrial fibrillation without cardioversion
Burden of atrial tachyarrhythmia
Evaluation by Holder monitoring at 12 months
Recurrence of atrial flutter
recurrence of atrial flutter > 30 second by ECG or Holder monitoring
Volume of ethanol and contrast agent used
ethanol volume, contrast agent volume used during the procedure
Full Information
NCT ID
NCT05652517
First Posted
November 28, 2022
Last Updated
December 14, 2022
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05652517
Brief Title
Univu-guided Vein of Marshall Ethanol Infusion (Marshall-Merge)
Official Title
Image Fusion of Integrating Fluoroscopy Into 3D Computed Tomography in Guidance of Vein of Marshall Ethanol Infusion During Persistent Atrial Fibrillation Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is a prospective, randomized, single-blind clinical trial aiming to compare two method in guidance of Vein of Marshall ethanol infusion (VOMEI), i.e., the conventional fluoroscopy-guided VOMEI and UNIVU-guided VOMEI.
Detailed Description
A total of 100 participants with persistent or longstanding persistent AF who undergo radiofrequency catheter ablation will be randomized assigned to two groups at 1:1 ratio to receive Vein of Marshall ethanol infusion (VOMEI).
Group 1: VOMEI guided by fluroscopy alone Group 2: VOMEI guided by fluoroscopy and CARTO UNIVU The intraprocedural major endpoints are the change in low-voltage area led by VOMEI (efficacy endpoint) and procedural complications (safety endpoint). The longterm major endpoint is the recurrence of atrial tachyarrhythmia between 3 and 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fluoroscopy-guided VOMEI
Arm Type
Active Comparator
Arm Description
Vein of Marshall ethanol infusion guided by fluoroscopy alone
Arm Title
UNIVU-guided VOMEI
Arm Type
Experimental
Arm Description
Vein of Marshall ethanol infusion guided by CARTO UNIVU and fluoroscopy
Intervention Type
Procedure
Intervention Name(s)
Vein of Marshall ethanol infusion
Intervention Description
Vein of Marshall ethanol infusion performed during the radiofrequency catheter ablation of persistent or long-standing persistent atrial fibrillation.
Primary Outcome Measure Information:
Title
Changes of low-voltage or scar area before and after VOMEI
Description
Left atrial voltage mapping will be performed before and after VOMEI. The low-voltage area or scar area will be mesured and compared before and after VOMEI
Time Frame
During the procedure
Title
Procedural complications
Description
Including cardiac tamponade, stroke, systemic embolism, major bleeding, acute coronary syndrome, acute heart failure, and death.
Time Frame
within 72 hours
Title
Recurrence of atrial tachyarrhythmias
Description
Including recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia
Time Frame
3 to 12 months
Secondary Outcome Measure Information:
Title
Rates of mitral isthmus block
Description
bidirectional block of mitral isthmus
Time Frame
During the procedure
Title
New low-voltage or scar area outside mitral isthmus and left pulmonary ridge
Description
New low-voltage or scar area after VOMEI outside the targeted regions
Time Frame
During the procedure
Title
Rates of VOMEI incomplete
Description
Any reason leading to incomplete VOMEI
Time Frame
During the procedure
Title
X ray exposure time
Description
Procedure-related temporal parameters
Time Frame
During the procedure
Title
procedure time
Description
Procedure-related temporal parameters
Time Frame
During the procedure
Title
radiofrequency ablation time
Description
Procedure-related temporal parameters
Time Frame
During the procedure
Title
Rates of intraprocedural termination of atrial fibrillation (not achieved by cardioversion)
Description
Termination of atrial fibrillation without cardioversion
Time Frame
During the procedure
Title
Burden of atrial tachyarrhythmia
Description
Evaluation by Holder monitoring at 12 months
Time Frame
12 months
Title
Recurrence of atrial flutter
Description
recurrence of atrial flutter > 30 second by ECG or Holder monitoring
Time Frame
3 to 12 months
Title
Volume of ethanol and contrast agent used
Description
ethanol volume, contrast agent volume used during the procedure
Time Frame
During the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 85 years
Sympathetic atrial fibrillation without previous ablation
Persistent or long-standing persistent AF
Patients' willing to undergo catheter ablation and VOMEI
Exclusion Criteria:
Left atrial or left atrial appendage thrombus
LVEF <30%
Cardiac surgery within 90 days
Myocardial infarction within 90 days
PCI or PTCA within 90 days
Thromboembolic events within 90 days, including stroke, pulmonary embolism, systemic embolism
Atrial myxoma
Congenital heart disease
Pregnant or pregnant plan
Acute or severe infection
Creatine> 221 μmol/L, or GFR <30 ml/min/1.73 m.
Unstable angina
Blood-clotting or bleeding disorder
Contraindication to anticoagulation
Life expectancy less than 1 year
Uncontrolled heart failure
Uncontrolled malignant tumor
Malformation of femoral vascular access
Without consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mu Chen, MD
Phone
021-25077287
Email
chenmu@xinhuamed.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Sun
Organizational Affiliation
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinhua hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Sun
Email
sunjian@xinhuamed.com.cn
12. IPD Sharing Statement
Learn more about this trial
Univu-guided Vein of Marshall Ethanol Infusion (Marshall-Merge)
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