C.Surgical Procedure; Cardiac Clinical Trial
Official title:
Bridge Occlusion Balloon Initial Use in Humans Study
NCT number | NCT02714153 |
Other study ID # | 1602017220 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | October 2017 |
Verified date | May 2021 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the use of an occlusion balloon (Bridge™ Occlusion Balloon, Spectranetics) within the Superior Vena Cava in lead extraction patients.
Status | Completed |
Enrollment | 23 |
Est. completion date | October 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Subject age more than 18 years - Lead extraction patients Exclusion Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Cooper University Health Care | Camden | New Jersey |
United States | Sanger Heart & Vascular Institute Carolinas HealthCare System | Charlotte | North Carolina |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Duke University Medical Center | Durham | North Carolina |
United States | University of Miami Hospital | Miami | Florida |
United States | United Hospital | Saint Paul | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Yale University | Spectranetics Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Time of Bridge Balloon Deployment | Time will be calculated in seconds starting from opening the Bridge Balloon Package up to full balloon deployment. | 33 minutes (average time) | |
Secondary | Number of Participants With Changes in Heart Rate at One Year | Heart Rate (in beat per minute) will be collected at 5 points: baseline, after guidewire insertion, at the time of balloon inflation, immediately post deflation and 5 minutes post deflation (all during the procedure itself). This outcome will be reported at the end of the study as if there were any unacceptable or no unacceptable changes in the hemodynamics over the course of the 12 month period. | 1 year | |
Secondary | Number of Participants With Changes in Blood Pressure at One Year | Blood pressure in mmHg will be collected at 5 points: baseline, after guidewire insertion, at the time of balloon inflation, immediately post deflation and 5 minutes post deflation (all during the procedure itself). This outcome will be reported at the end of the study as as if there were any unacceptable or no unacceptable changes in the hemodynamics over the course of the 12 month period.. | 1 year | |
Secondary | Number of Participants With Changes in SPO2 at One Year | SPO2 will be collected at 5 points: baseline, after guidewire insertion, at the time of balloon inflation, immediately post deflation and 5 minutes post deflation (all during the procedure itself). This outcome will be reported at the end of the study as if there were any unacceptable or no unacceptable changes in the hemodynamics over the course of the 12 month period.. | 1 year |
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