Half-normal Saline in Idiopathic Left Ventricular Outflow... | NCT03502499

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

NCT03502499

Sponsor

Texas Cardiac Arrhythmia Research Foundation

Status

Suspended

Last Update Posted

Apr 11, 2022Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Ventricular Arrythmia

Interventions

Half-normal saline
Normal saline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

slow enrollment

Expanded Access Info

Start Date

May 16, 2018Actual

Primary Completion Date

Apr 2022Estimated

Completion Date

Apr 2022Estimated

First Submitted Date

Apr 4, 2018

First Submission Date that Met QC Criteria

Apr 10, 2018

First Posted Date

Apr 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2022

Last Update Posted Date

Apr 11, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrea Natale, Executive Medical Director, Texas Cardiac Arrhythmia Research FoundationPrincipal Investigator

Lead Sponsor

Texas Cardiac Arrhythmia Research FoundationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Half-normal saline	Experimental		Drug: Half-normal saline
Normal saline	Active Comparator		Drug: Normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Half-normal saline	Drug	Use of half-normal saline as an irrigant for open-irrigated ablation catheters	Half-normal saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
procedure-related complications	pericardial effusion due to cardiac perforation or pericarditis, transient ischemic attack/stroke, systemic embolism, coronary artery injury, death	periprocedural (at the time of the procedure and up to 1 month)
hyponatremia

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrea Natale, MD	Texas Cardiac Arrhythmia Institute, St. David's Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Hospital		Aurora	Colorado	80045	United States
Texas Cardiac Arrhythmia Institute, St. David's Medical Center

Intervention Browse Module

MeSH Terms

ID	Term
D000077330	Saline Solution

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

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