A Randomized Comparison of the Use of JET and Conventional Ventilation in Pulmonary Vein Isolation

NCT02664311 | Terminated Results DMC

• 1 other identifier: 2012P000419
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized prospective study comparing outcomes of pulmonary vein isolation using conventional and jet ventilation.

Conditions

Atrial Fibrillation

Keywords

Pulmonary Vein Isolation; Jet Ventilation; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Isolation Time

  Comparison of Time (in Minutes) From Obtaining Access to Left Atrium Via Transseptal Catheterization to Demonstrated Isolation of All Pulmonary Veins - hypothesis is that with Jet ventilation there will be a shorter time to pulmonary vein isolation in comparison to conventional ventilation

  Immediate post procedure

Secondary Outcomes (2)

• Freedom From AF

  1 year

• Fluoroscopy Time

  Immediate post-procedure

Study Arms (2)

Conventional Ventilation

PLACEBO COMPARATOR

Patients receiving conventional ventilation for the duration of this study

Device: Conventional ventilation

Jet Ventilation

ACTIVE COMPARATOR

Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium

Device: Jet Ventilation

Interventions

Jet Ventilation DEVICE

Patients are randomized to receive either jet or conventional ventilation during this study

Jet Ventilation

Conventional ventilation DEVICE

Conventional ventilator - control arm

Conventional Ventilation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• paroxysmal or persistent AF, first time PVI or left atrial procedure

You may not qualify if:

• repeat procedure
• any contraindications to receiving JET ventilation in the judgement of the treating anesthesiologist

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

High-Frequency Jet Ventilation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

High-Frequency Ventilation; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Eleanor Greene
• Organization: Beth Israel Deaconess Medical Center

ergreene@bidmc.harvard.edu

617-667-1836

Study Officials

• Peter Zimetbaum, MD

  Beth Israel Deaconess Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: January 27, 2016
• Study Start: February 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 10, 2017
• Results First Posted: April 10, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)