Trial · NCT01898221

Vein of Marshall Ethanol Infusion for Persistent Atrial Fibrillation

NCT01898221, Phase 3, Completed, The Methodist Hospital Research Institute; results first posted 2025-08-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vein of Marshall Ethanol Infusion for Persistent Atrial Fibrillation. Trials, record NCT01898221. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01898221

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Vein of Marshall Ethanol Infusion for Persistent Atrial Fibrillation
NCT number: NCT01898221
Status: Completed
Phases: Phase 3
Enrollment: 343 participants, actual
Lead sponsor: The Methodist Hospital Research Institute
Conditions: Ventricular Tachycardia, Atrial Fibrillation
Interventions: Ethanol, Ablation
First posted: 2013-07-12
Last updated: 2025-08-21
Results first posted: 2025-08-21

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Amount of Treated Subjects With Freedom of Symptomatic Post-procedural AF or Flutter at 12 and 15 Months Post Procedure and Less Than 1 Min/Day of AF or Flutter on 4-week EKG Monitor.	15 months	Primary Endpoints: The primary outcome is freedom from symptomatic post-procedural AF or flutter at 12 and 15 months from the procedure and less than 1 min/day of AF or flutter on 4-week EKG monitor.
Secondary	Number of Patients With Clinical Success	90 days	Freedom from AF/AT after \>1 procedure.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Amount of Treated Subjects With Freedom of Symptomatic Post-procedural AF or Flutter at 12 and 15 Months Post Procedure and Less Than 1 Min/Day of AF or Flutter on 4-week EKG Monitor.	15 months	total of 343 patients randomized to study which included 158 randomized to standard ablation and 185 to VOM + Standard ablation.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients With Clinical Success	90 days		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Amount of Treated Subjects With Freedom of Symptomatic Post-procedural AF or Flutter at 12 and 15 Months Post Procedure and Less Than 1 Min/Day of AF or Flutter on 4-week EKG Monitor.	Standard Catheter Ablation Patient Group	60	Participants
Amount of Treated Subjects With Freedom of Symptomatic Post-procedural AF or Flutter at 12 and 15 Months Post Procedure and Less Than 1 Min/Day of AF or Flutter on 4-week EKG Monitor.	Vein of Marshall and Standar Procedure	91	Participants
Number of Patients With Clinical Success	Standard Catheter Ablation Patient Group	84	Participants
Number of Patients With Clinical Success	Vein of Marshall and Standar Procedure	115	Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Standard Catheter Ablation Patient Group	158
Overall Study	STARTED	Vein of Marshall and Standar Procedure	185
Overall Study	COMPLETED	Standard Catheter Ablation Patient Group	142
Overall Study	COMPLETED	Vein of Marshall and Standar Procedure	168
Overall Study	NOT COMPLETED	Standard Catheter Ablation Patient Group	16
Overall Study	NOT COMPLETED	Vein of Marshall and Standar Procedure	17

Source ClinicalTrials.gov

Adverse events16

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	vascular access complications	Injury, poisoning and procedural complications	Standard Catheter Ablation Patient Group	8	158	8
serious	vascular access complications	Injury, poisoning and procedural complications	Vein of Marshall and Standar Procedure	3	185	3
serious	intraprocedural pericardial effusion	Injury, poisoning and procedural complications	Standard Catheter Ablation Patient Group	1	158	1
serious	intraprocedural pericardial effusion	Injury, poisoning and procedural complications	Vein of Marshall and Standar Procedure	2	185	2
serious	subacute pericardial effusion/perocarditis	Cardiac disorders	Standard Catheter Ablation Patient Group	6	158	6
serious	subacute pericardial effusion/perocarditis	Cardiac disorders	Vein of Marshall and Standar Procedure	11	185	11
serious	stroke/TIA	Vascular disorders	Standard Catheter Ablation Patient Group	4	158	4
serious	stroke/TIA	Vascular disorders	Vein of Marshall and Standar Procedure	3	185	3
serious	fluid overload	Cardiac disorders	Standard Catheter Ablation Patient Group	2	158	2
serious	fluid overload	Cardiac disorders	Vein of Marshall and Standar Procedure	10	185	10

1 to 10 of 16Source ClinicalTrials.gov

See all 16 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Standard Catheter Ablation Patient Group	2	158
Total, all-cause mortality	Vein of Marshall and Standar Procedure	4	185
Total, other adverse events	Standard Catheter Ablation Patient Group	0	158
Total, other adverse events	Vein of Marshall and Standar Procedure	0	185
Total, serious adverse events	Standard Catheter Ablation Patient Group	29	158
Total, serious adverse events	Vein of Marshall and Standar Procedure	38	185

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22429895	BACKGROUND	PubMed
33107945	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01HL115003	Vein of Marshall Ethanol Infusion for Persistent Atrial Fibrillation	VALDERRABANO, MIGUEL	METHODIST HOSPITAL RESEARCH INSTITUTE	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2013 to 2017

Source NIH RePORTER

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Standard Catheter Ablation Patient Group vs Vein of Marshall and Standar Procedure: Number of Patients With Clinical Success	Trial comparisons
Standard Catheter Ablation Patient Group vs Vein of Marshall and Standar Procedure: Amount of Treated Subjects With Freedom of Symptomatic Post-procedural AF or Flutter at 12 and 15 Months Post Procedure and Less Than 1 Min/Day of AF or Flutter on 4-week EKG Monitor.	Trial comparisons
Standard Catheter Ablation Patient Group vs Vein of Marshall and Standar Procedure: deaths from any cause	Trial comparisons
Standard Catheter Ablation Patient Group vs Vein of Marshall and Standar Procedure: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01898221

GET https://conductscience.org/api/trials/v1/NCT01898221/registered

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