NCT02714153

Brief Summary

To evaluate the use of an occlusion balloon (Bridge™ Occlusion Balloon, Spectranetics) within the Superior Vena Cava in lead extraction patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

April 6, 2021

Completed
Last Updated

June 14, 2021

Status Verified

May 1, 2021

Enrollment Period

1.1 years

First QC Date

March 4, 2016

Results QC Date

August 19, 2020

Last Update Submit

May 19, 2021

Conditions

C.Surgical Procedure; CardiacCardiac DysrhythmiaDisorder of Pacing Function

Keywords

Lead extractionSuperior Vena Cava TearPacemaker/Defibrillator lead extraction

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Successful Balloon Occlusion of Superior Vena Cava

    After Bridge Balloon deployment and inflation, the degree of blood vessel occlusion will be reported. Measurements will be calculated from fluoroscopic images (using x-ray machine) and venograms (images with injection of contrast agent). Successful balloon occlusion of the superior vena cava (SVC) is defined as \>90% occlusion of the SVC by visual estimate using conventional venography.

    33 minutes (average time)

Secondary Outcomes (4)

  • Time of Bridge Balloon Deployment

    33 minutes (average time)

  • Number of Participants With Changes in Heart Rate at One Year

    1 year

  • Number of Participants With Changes in Blood Pressure at One Year

    1 year

  • Number of Participants With Changes in SPO2 at One Year

    1 year

Study Arms (1)

Bridge Occlusion Balloon

EXPERIMENTAL

Bridge Balloon catheter is designed to be used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage associated with vascular tears that may occur during lead extraction procedures.

Device: Bridge Balloon

Interventions

Bridge BalloonDEVICE

The Bridge Balloon will be used in a non-emergent setting to allow for evaluation of how best to integrate this new technology into the investigators clinical practice. The study will focus on the effect of the Bridge balloon on the patient preparation clinical workflow, ease of insertion/positioning/deployment, and the ability to recognize proper inflation and vein sealing under fluoroscopy.

Also known as: Bridge Occlusion Balloon, Spectranetics
Bridge Occlusion Balloon

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject age more than 18 years
  • Lead extraction patients

You may not qualify if:

  • Lead extraction patients with:
  • Superior Vena Cava occlusion or stenosis.
  • Significant vegetation.
  • Hemodynamic instability.
  • Class IV heart failure
  • Creatinine \> 2.0mg/dL
  • Patients \> 85 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Miami Hospital

Miami, Florida, 33125, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02118, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Cooper University Health Care

Camden, New Jersey, 08103, United States

Location

Sanger Heart & Vascular Institute Carolinas HealthCare System

Charlotte, North Carolina, 28203, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Jude Clancy, MD Associate Professor Term; Director, Lead Management Program
Organization
Yale School of Medicine
jude.clancy@yale.edu
(203) 785-4126

Study Officials

  • Jude Clancy, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 21, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2017

Study Completion

October 1, 2017

Last Updated

June 14, 2021

Results First Posted

April 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(7)