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

NCT03502499 | Suspended

• 1 other identifier: TCAI_HNS_VA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Ventricular Arrythmia

Outcome Measures

Primary Outcomes (3)

• total radiofrequency ablation time, and total procedure time

  intraprocedural

• acute success

  elimination of the VAs, or \<10 morphologically similar PVCs during a 15-minute waiting period

  intraprocedural

• long-term success

  elimination of the VAs, or a reduction of \>75% of the PVC burden associated with marked improved in symptoms

  1 year

Other Outcomes (2)

• procedure-related complications

  periprocedural (at the time of the procedure and up to 1 month)

• hyponatremia

  periprocedural (at the time of the procedure and up to 1 month)

Study Arms (2)

Half-normal saline

EXPERIMENTAL

Drug: Half-normal saline

Normal saline

ACTIVE COMPARATOR

Drug: Normal saline

Interventions

Half-normal saline DRUG

Use of half-normal saline as an irrigant for open-irrigated ablation catheters

Half-normal saline

Normal saline DRUG

Use of normal saline as an irrigant for open-irrigated ablation catheters

Normal saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Cardiac Arrhythmia Research Foundation: lead

Study Sites (2)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Texas Cardiac Arrhythmia Institute, St. David's Medical Center

Austin, Texas, 78705, United States

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Andrea Natale, MD

  Texas Cardiac Arrhythmia Institute, St. David's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Medical Director

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 18, 2018
• Study Start: May 16, 2018
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: April 11, 2022

Record last verified: 2022-04

Locations

US (2)