Trial Outcomes & Findings for Vein of Marshall Ethanol Infusion for Persistent Atrial Fibrillation (NCT NCT01898221)

NCT ID: NCT01898221

Last Updated: 2025-08-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 343 participants
• Primary outcome timeframe: 15 months
• Results posted on: 2025-08-21

Participant Flow

Participant milestones

Measure	Standard Catheter Ablation Patient Group Patients will have a standard procedure ablation Ablation: The doctor will perform only the standard procedure. Throughout the procedure, the researchers will document the following information for ALL patients: measurements such as whether the treatment was successful or unsuccessful, X-ray exposure time, procedure time, whether there were any complications, and other general procedural measurements.	Vein of Marshall and Standar Procedure The doctor will inject Ethanol through a balloon catheter into the VOM Ethanol: We enter the CS with a sheath advanced from the right internal jugular vein. A sub-selector catheter with a \~90° angle at the tip (typically, a left internal mammary artery angioplasty guide catheter) is advanced through the CS sheath with its tip pointing superiorly and posteriorly.
Overall Study STARTED	158	185
Overall Study COMPLETED	142	168
Overall Study NOT COMPLETED	16	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vein of Marshall Ethanol Infusion for Persistent Atrial Fibrillation

Baseline characteristics by cohort

Measure	Standard Catheter Ablation Patient Group n=158 Participants Patients will have a standard procedure ablation Ablation: The doctor will perform only the standard procedure. Throughout the procedure, the researchers will document the following information for ALL patients: measurements such as whether the treatment was successful or unsuccessful, X-ray exposure time, procedure time, whether there were any complications, and other general procedural measurements.	Vein of Marshall and Standar Procedure n=185 Participants The doctor will inject Ethanol through a balloon catheter into the VOM Ethanol: We enter the CS with a sheath advanced from the right internal jugular vein. A sub-selector catheter with a \~90° angle at the tip (typically, a left internal mammary artery angioplasty guide catheter) is advanced through the CS sheath with its tip pointing superiorly and posteriorly.	Total n=343 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	100 Participants n=5 Participants	100 Participants n=7 Participants	200 Participants n=5 Participants
Age, Categorical >=65 years	58 Participants n=5 Participants	85 Participants n=7 Participants	143 Participants n=5 Participants
Age, Continuous	66.4 years STANDARD_DEVIATION 9.9 • n=5 Participants	66.6 years STANDARD_DEVIATION 9.6 • n=7 Participants	66.5 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	48 Participants n=7 Participants	82 Participants n=5 Participants
Sex: Female, Male Male	124 Participants n=5 Participants	137 Participants n=7 Participants	261 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	150 Participants n=5 Participants	169 Participants n=7 Participants	319 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	158 participants n=5 Participants	185 participants n=7 Participants	343 participants n=5 Participants

PRIMARY outcome

Timeframe: 15 months

Population: total of 343 patients randomized to study which included 158 randomized to standard ablation and 185 to VOM + Standard ablation.

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.

Outcome measures

Measure	Standard Catheter Ablation Patient Group n=158 Participants Patients will have a standard procedure ablation Ablation: The doctor will perform only the standard procedure. Throughout the procedure, the researchers will document the following information for ALL patients: measurements such as whether the treatment was successful or unsuccessful, X-ray exposure time, procedure time, whether there were any complications, and other general procedural measurements.	Vein of Marshall and Standar Procedure n=185 Participants The doctor will inject Ethanol through a balloon catheter into the VOM Ethanol: We enter the CS with a sheath advanced from the right internal jugular vein. A sub-selector catheter with a \~90° angle at the tip (typically, a left internal mammary artery angioplasty guide catheter) is advanced through the CS sheath with its tip pointing superiorly and posteriorly.
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.	60 Participants	91 Participants

SECONDARY outcome

Timeframe: 90 days

Freedom from AF/AT after >1 procedure.

Outcome measures

Measure	Standard Catheter Ablation Patient Group n=158 Participants Patients will have a standard procedure ablation Ablation: The doctor will perform only the standard procedure. Throughout the procedure, the researchers will document the following information for ALL patients: measurements such as whether the treatment was successful or unsuccessful, X-ray exposure time, procedure time, whether there were any complications, and other general procedural measurements.	Vein of Marshall and Standar Procedure n=185 Participants The doctor will inject Ethanol through a balloon catheter into the VOM Ethanol: We enter the CS with a sheath advanced from the right internal jugular vein. A sub-selector catheter with a \~90° angle at the tip (typically, a left internal mammary artery angioplasty guide catheter) is advanced through the CS sheath with its tip pointing superiorly and posteriorly.
Number of Patients With Clinical Success	84 Participants	115 Participants

Adverse Events

Standard Catheter Ablation Patient Group

Serious events: 29 serious events

Other events: 0 other events

Deaths: 2 deaths

Vein of Marshall and Standar Procedure

Serious events: 38 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Measure	Standard Catheter Ablation Patient Group n=158 participants at risk Patients will have a standard procedure ablation Ablation: The doctor will perform only the standard procedure. Throughout the procedure, the researchers will document the following information for ALL patients: measurements such as whether the treatment was successful or unsuccessful, X-ray exposure time, procedure time, whether there were any complications, and other general procedural measurements.	Vein of Marshall and Standar Procedure n=185 participants at risk The doctor will inject Ethanol through a balloon catheter into the VOM Ethanol: We enter the CS with a sheath advanced from the right internal jugular vein. A sub-selector catheter with a \~90° angle at the tip (typically, a left internal mammary artery angioplasty guide catheter) is advanced through the CS sheath with its tip pointing superiorly and posteriorly.
Injury, poisoning and procedural complications vascular access complications	5.1% 8/158 • Number of events 8 • AE data collected for 1 year post ablation. This was FU period for patients enrolled in the trial.	1.6% 3/185 • Number of events 3 • AE data collected for 1 year post ablation. This was FU period for patients enrolled in the trial.
Injury, poisoning and procedural complications intraprocedural pericardial effusion	0.63% 1/158 • Number of events 1 • AE data collected for 1 year post ablation. This was FU period for patients enrolled in the trial.	1.1% 2/185 • Number of events 2 • AE data collected for 1 year post ablation. This was FU period for patients enrolled in the trial.
Cardiac disorders subacute pericardial effusion/perocarditis	3.8% 6/158 • Number of events 6 • AE data collected for 1 year post ablation. This was FU period for patients enrolled in the trial.	5.9% 11/185 • Number of events 11 • AE data collected for 1 year post ablation. This was FU period for patients enrolled in the trial.
Vascular disorders stroke/TIA	2.5% 4/158 • Number of events 4 • AE data collected for 1 year post ablation. This was FU period for patients enrolled in the trial.	1.6% 3/185 • Number of events 3 • AE data collected for 1 year post ablation. This was FU period for patients enrolled in the trial.
Cardiac disorders fluid overload	1.3% 2/158 • Number of events 2 • AE data collected for 1 year post ablation. This was FU period for patients enrolled in the trial.	5.4% 10/185 • Number of events 10 • AE data collected for 1 year post ablation. This was FU period for patients enrolled in the trial.
Respiratory, thoracic and mediastinal disorders pneumonia	2.5% 4/158 • Number of events 4 • AE data collected for 1 year post ablation. This was FU period for patients enrolled in the trial.	1.6% 3/185 • Number of events 3 • AE data collected for 1 year post ablation. This was FU period for patients enrolled in the trial.
Cardiac disorders Subacue pericaridal effusion requiring drainage	1.3% 2/158 • Number of events 2 • AE data collected for 1 year post ablation. This was FU period for patients enrolled in the trial.	1.1% 2/185 • Number of events 2 • AE data collected for 1 year post ablation. This was FU period for patients enrolled in the trial.
General disorders deaths - not related to procedure	1.3% 2/158 • Number of events 2 • AE data collected for 1 year post ablation. This was FU period for patients enrolled in the trial.	2.2% 4/185 • Number of events 4 • AE data collected for 1 year post ablation. This was FU period for patients enrolled in the trial.

Other adverse events

Adverse event data not reported

Additional Information

Miguel Valderrabano, MD

Houston Methodist Hospital, Dept of Cardiology

Phone: 713 441 5231

Email: MValderrabano@houstonmethodist.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place