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Venous Ethanol for Ventricular Tachycardia (VELVET)

Primary Purpose

Ventricular Tachycardia, Ischemic Cardiomyopathy

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Venous ethanol

Catheter ablation

About this trial

This is an interventional treatment trial for Ventricular Tachycardia focused on measuring Ventricular tachycardia, Coronary veins, Ethanol, Ablation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female, ages of 18 and 85 years and with a prior ICD implant
Diagnosed with ischemic cardiomyopathy: Prior myocardial infarction (pathological Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause)
One of the following VT events (within last 6 months): a) ≥3 episodes of VT treated with anti-tachycardia pacing (ATP) or anti-arrhythmic drugs; b) ≥1 appropriate ICD shocks; c) ≥3 VT episodes within 24 hr; d) sustained VT below detection rate of the ICD documented by EKG/cardiac monitor
Patients deemed candidates for RF ablation of VT
Able and willing to comply with pre-, post-, and follow-up requirements
Willing to sign the informed consent

Exclusion Criteria:

Serum creatinine >1.5 mg/dL, or creatinine clearance <30 ml/min
Left ventricular (LV) ejection fraction ≤10%
Mobile LV thrombus on echocardiography
Absence of vascular access to the LV
Disease process likely to limit survival to <12 months
New York Heart Association class IV heart failure
Cardiac surgery within the past 2 months (unless VT was incessant),
Acute coronary syndrome in the past 2 months (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on EKG)
Another reversible cause of VT (e.g. electrolyte abnormalities, drug-induced arrhythmia)
Severe aortic stenosis or mitral regurgitation with a flail leaflet
Pregnancy
Unwilling or unable to provide informed consent
Covid-19 positive testing within 14 days of randomization procedure
Enrolled, or planning to get enrolled, in another research study during his/her participation on the Velvet trial

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Venous ethanol

Arm Description

Endocardial radiofrequency ablation of ventricular tachycardia

Endocardial radiofrequency ablation of ventricular tachycardia combined with venous ethanol ablation of the tachycardia substrate

Outcomes

Primary Outcome Measures

Ventricular tachycardia recurrence

Detection of VT on defibrillator

Hospitalization for cardiac causes

Severe procedural complications

Severe procedural complications include bleeding requiring transfusion, stroke or systemic embolization, pericardial tamponade, myocardial infarction, and vascular complications requiring surgery, plus cardiogenic shock requiring unplanned mechanical support.

Death

Secondary Outcome Measures

Procedural time

Total procedure time (minutes)

Need for unplanned mechanical hemodynamic support

Unplanned use of intra-aortic balloon pump or ventricular assist device during procedure (Yes/No)

Repeat ablation procedures, including epicardial

Need for repeat procedure (Yes/No)

All-cause mortality

Appropriate ICD therapies: antitachycardia pacing and ICD shocks

Presence of appropriate ICD therapies on interrogation

Inappropriate ICD therapies: antitachycardia pacing and ICD shocks

Presence of inappropriate ICD therapies on interrogation

Change in ICD therapies compared to 3-months pre-randomization

Comparison of number of therapies on ICD interrogation

Vt storm

More than 2 episodes of VT within a 24h period

Sustained VT below detection rate

Change in left ventricular ejection fraction (percent)

Measured before and 3 months after procedure

Quality of life measurement using SF-32 questionnaire

Scores range from 0 - 100; Lower scores = more disability, higher scores = less disability

Hospital admission for cardiac causes (including heart failure exacerbation)

Hospitalization due to cardiac arrhythmia, heart failure exacerbation and other cardiac causes (yes/no)

Antiarrhtyhmic therapy

Number of antiarrhythmic drugs before and after ablation

Freedom from VT after repeat procedures

Recurrence of VT (yes/no) including patients that have multiple ablations

Cardiac transplant or left ventricular assist device implantation

As a measure of deterioration of cardiac status, requirement of transplant of ventricular assist device implant (yes/no) will be compared

Fluoroscopy time

Total time of fluoroscopy use (minutes)

Total contrast agent used

Amount of radiographic contrast used (cc)

Full Information

NCT ID

NCT05511246

First Posted

August 8, 2022

Last Updated

August 19, 2022

Sponsor

The Methodist Hospital Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT05511246

Brief Title

Venous Ethanol for Ventricular Tachycardia

Acronym

VELVET

Official Title

Venous Ethanol for Ischemic Left Ventricular Tachycardia

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 2023 (Anticipated)

Primary Completion Date

December 2027 (Anticipated)

Study Completion Date

December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Methodist Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Comparative effectiveness randomized clinical trial, comparing endocardial radiofrequency ablation alone vs radiofrequency ablation combined with venous ethanol in patients with ischemic ventricular tachycardia -Venous Ethanol for Left Ventricular Ischemic Ventricular Tachycardia -VELVET clinical trial

Detailed Description

Patients with ventricular tachycardia (VT) in the context of ischemic heart disease suffer from significant morbidity and mortality. Catheter ablation can improve outcomes but has suboptimal ablation results. Ethanol ablation via epicardial veins can add significant therapeutic value to catheter ablation by increasing reach to intramural VT substrates. Investigators will randomize patients with ischemic VT to either endocardial catheter ablation alone, or combined with venous ethanol (VE) ablation of coronary veins located on the epicardial aspect of the VT substrates. A combined primary endpoint: VT recurrence, procedural complications, hospitalization for cardiac causes, and death, will be measured over a 12-month follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventricular Tachycardia, Ischemic Cardiomyopathy

Keywords

Ventricular tachycardia, Coronary veins, Ethanol, Ablation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Endocardial radiofrequency ablation of ventricular tachycardia

Arm Title

Venous ethanol

Arm Type

Experimental

Arm Description

Endocardial radiofrequency ablation of ventricular tachycardia combined with venous ethanol ablation of the tachycardia substrate

Intervention Type

Drug

Intervention Name(s)

Venous ethanol

Other Intervention Name(s)

Alcohol

Intervention Description

Cannulation of coronary vein or veins in the VT substrate and balloon injection of ethanol

Intervention Type

Procedure

Intervention Name(s)

Catheter ablation

Intervention Description

Endocardial catheter ablation of VT substrate

Primary Outcome Measure Information:

Title

Ventricular tachycardia recurrence

Description

Detection of VT on defibrillator

Time Frame

0-12 months

Title

Hospitalization for cardiac causes

Time Frame

0-12 months

Title

Severe procedural complications

Description

Time Frame

0-12 months

Title

Death

Time Frame

0-12 months

Secondary Outcome Measure Information:

Title

Procedural time

Description

Total procedure time (minutes)

Time Frame

During procedure

Title

Need for unplanned mechanical hemodynamic support

Description

Unplanned use of intra-aortic balloon pump or ventricular assist device during procedure (Yes/No)

Time Frame

During procedure

Title

Repeat ablation procedures, including epicardial

Description

Need for repeat procedure (Yes/No)

Time Frame

0-12 months

Title

All-cause mortality

Time Frame

0-12 months

Title

Appropriate ICD therapies: antitachycardia pacing and ICD shocks

Description

Presence of appropriate ICD therapies on interrogation

Time Frame

0-12 months

Title

Inappropriate ICD therapies: antitachycardia pacing and ICD shocks

Description

Presence of inappropriate ICD therapies on interrogation

Time Frame

0-12 months

Title

Change in ICD therapies compared to 3-months pre-randomization

Description

Comparison of number of therapies on ICD interrogation

Time Frame

0-12 months

Title

Vt storm

Description

More than 2 episodes of VT within a 24h period

Time Frame

0-12 months

Title

Sustained VT below detection rate

Time Frame

0-12 months

Title

Change in left ventricular ejection fraction (percent)

Description

Measured before and 3 months after procedure

Time Frame

Before and 3 months post-procedure

Title

Quality of life measurement using SF-32 questionnaire

Description

Scores range from 0 - 100; Lower scores = more disability, higher scores = less disability

Time Frame

0-12 months

Title

Hospital admission for cardiac causes (including heart failure exacerbation)

Description

Hospitalization due to cardiac arrhythmia, heart failure exacerbation and other cardiac causes (yes/no)

Time Frame

0-12 months

Title

Antiarrhtyhmic therapy

Description

Number of antiarrhythmic drugs before and after ablation

Time Frame

0-12 months

Title

Freedom from VT after repeat procedures

Description

Recurrence of VT (yes/no) including patients that have multiple ablations

Time Frame

0-12 months

Title

Cardiac transplant or left ventricular assist device implantation

Description

As a measure of deterioration of cardiac status, requirement of transplant of ventricular assist device implant (yes/no) will be compared

Time Frame

0-12 months

Title

Fluoroscopy time

Description

Total time of fluoroscopy use (minutes)

Time Frame

During procedure

Title

Total contrast agent used

Description

Amount of radiographic contrast used (cc)

Time Frame

During procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female, ages of 18 and 85 years and with a prior ICD implant Diagnosed with ischemic cardiomyopathy: Prior myocardial infarction (pathological Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause) One of the following VT events (within last 6 months): a) ≥3 episodes of VT treated with anti-tachycardia pacing (ATP) or anti-arrhythmic drugs; b) ≥1 appropriate ICD shocks; c) ≥3 VT episodes within 24 hr; d) sustained VT below detection rate of the ICD documented by EKG/cardiac monitor Patients deemed candidates for RF ablation of VT Able and willing to comply with pre-, post-, and follow-up requirements Willing to sign the informed consent Exclusion Criteria: Serum creatinine >1.5 mg/dL, or creatinine clearance <30 ml/min Left ventricular (LV) ejection fraction ≤10% Mobile LV thrombus on echocardiography Absence of vascular access to the LV Disease process likely to limit survival to <12 months New York Heart Association class IV heart failure Cardiac surgery within the past 2 months (unless VT was incessant), Acute coronary syndrome in the past 2 months (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on EKG) Another reversible cause of VT (e.g. electrolyte abnormalities, drug-induced arrhythmia) Severe aortic stenosis or mitral regurgitation with a flail leaflet Pregnancy Unwilling or unable to provide informed consent Covid-19 positive testing within 14 days of randomization procedure Enrolled, or planning to get enrolled, in another research study during his/her participation on the Velvet trial

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

LaShawna Green, RN

Phone

7134415231

lagreen2@houstonmethodist.org

First Name & Middle Initial & Last Name or Official Title & Degree

Susmitha Gadde, RN

Phone

713-441-6548

Sgadde@houstonmethodist.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Miguel Valderrabano, MD

Organizational Affiliation

The Methodist Hospital Research Institute

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

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Venous Ethanol for Ventricular Tachycardia

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