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Half-normal Saline in Idiopathic Left Ventricular Outflow Tract Arrhythmias Ablation

Primary Purpose

Ventricular Arrythmia

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Half-normal saline
Normal saline
Sponsored by
Texas Cardiac Arrhythmia Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ventricular Arrythmia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • male or female between 18 and 75 years of age at the time of enrollment
  • undergoing first-time radiofrequency ablation for left ventricular outflow tract ventricular arrhythmias
  • written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion criteria

  • ventricular arrhythmias originating from the right ventricular outflow tract according to the ventricular arrhythmia ECG morphology (i.e., precordial R wave transition at V3 or later)
  • ventricular arrhythmias not originating from cardiac outflow tracts
  • baseline hyponatremia (serum sodium level < 135 mEq/L)
  • pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
  • presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data

Sites / Locations

  • University of Colorado Hospital
  • Texas Cardiac Arrhythmia Institute, St. David's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Half-normal saline

Normal saline

Arm Description

Outcomes

Primary Outcome Measures

total radiofrequency ablation time, and total procedure time
acute success
elimination of the VAs, or <10 morphologically similar PVCs during a 15-minute waiting period
long-term success
elimination of the VAs, or a reduction of >75% of the PVC burden associated with marked improved in symptoms

Secondary Outcome Measures

Full Information

First Posted
April 4, 2018
Last Updated
April 1, 2022
Sponsor
Texas Cardiac Arrhythmia Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03502499
Brief Title
Half-normal Saline in Idiopathic Left Ventricular Outflow Tract Arrhythmias Ablation
Official Title
Half-normal Saline vs Normal Saline for Irrigation of Open-irrigated Radiofrequency Catheters in Idiopathic Left Ventricular Outflow Tract Arrhythmias Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Suspended
Why Stopped
slow enrollment
Study Start Date
May 16, 2018 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Cardiac Arrhythmia Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters during left ventricular outflow tract ventricular arrhythmias ablation. By increasing the efficacy of radiofrequency energy-mediated lesion formation, half-normal saline has the potential to reduce procedural times and improved acute and long-term outcomes.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Half-normal saline
Arm Type
Experimental
Arm Title
Normal saline
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Half-normal saline
Intervention Description
Use of half-normal saline as an irrigant for open-irrigated ablation catheters
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Use of normal saline as an irrigant for open-irrigated ablation catheters
Primary Outcome Measure Information:
Title
total radiofrequency ablation time, and total procedure time
Time Frame
intraprocedural
Title
acute success
Description
elimination of the VAs, or <10 morphologically similar PVCs during a 15-minute waiting period
Time Frame
intraprocedural
Title
long-term success
Description
elimination of the VAs, or a reduction of >75% of the PVC burden associated with marked improved in symptoms
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
procedure-related complications
Description
pericardial effusion due to cardiac perforation or pericarditis, transient ischemic attack/stroke, systemic embolism, coronary artery injury, death
Time Frame
periprocedural (at the time of the procedure and up to 1 month)
Title
hyponatremia
Description
serum sodium level < 135 mEq/L
Time Frame
periprocedural (at the time of the procedure and up to 1 month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria male or female between 18 and 75 years of age at the time of enrollment undergoing first-time radiofrequency ablation for left ventricular outflow tract ventricular arrhythmias written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study Exclusion criteria ventricular arrhythmias originating from the right ventricular outflow tract according to the ventricular arrhythmia ECG morphology (i.e., precordial R wave transition at V3 or later) ventricular arrhythmias not originating from cardiac outflow tracts baseline hyponatremia (serum sodium level < 135 mEq/L) pregnant, breastfeeding, or unwilling to practice birth control during participation in the study presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Organizational Affiliation
Texas Cardiac Arrhythmia Institute, St. David's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Texas Cardiac Arrhythmia Institute, St. David's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States

12. IPD Sharing Statement

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Half-normal Saline in Idiopathic Left Ventricular Outflow Tract Arrhythmias Ablation

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