C.Surgical Procedure; CardiacNCT02714153
Bridge Occlusion Balloon in Lead Extraction Procedure
A study testing Bridge Balloon in people with C.Surgical Procedure; Cardiac and Cardiac Dysrhythmia, run by Yale University at 7 sites in United States.
Trial summary
To evaluate the use of an occlusion balloon (Bridge™ Occlusion Balloon, Spectranetics) within the Superior Vena Cava in lead extraction patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- C.Surgical Procedure; Cardiac, Cardiac Dysrhythmia, Disorder of Pacing Function
- What is being tested?
- Bridge Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject age more than 18 years
- Lead extraction patients
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02118
Cooper University Health Care
Camden, New Jersey, 08103
Sanger Heart & Vascular Institute Carolinas HealthCare System
Charlotte, North Carolina, 28203
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27705
University of Miami Hospital
Miami, Florida, 33125
United Hospital
Saint Paul, Minnesota, 55102
About this study
Official title: Bridge Occlusion Balloon Initial Use in Humans Study
To evaluate the use of an occlusion balloon (Bridge™ Occlusion Balloon, Spectranetics) within the Superior Vena Cava in lead extraction patients.
Read the detailed description
This study will evaluate the use of an occlusion balloon (Bridge™ Occlusion Balloon, Spectranetics) within the Superior Vena Cava in lead extraction patients. This will be performed 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. Understanding these factors will help build a more robust clinical workflow with the goal of better patient outcomes in the case of an Superior Vena Cava injury. The images and data generated during this study can help in dissemination of the practical use knowledge to fellow lead extractors.
At the time of the protocol registration, the timeframe 12 months was entered, this was actually the anticipated length of the study at registration. The timeframe was corrected to 33 minutes (average time) at the time of results entry.
- Being tested
- Bridge Balloon
- Keywords
- Lead extraction, Superior Vena Cava Tear, Pacemaker/Defibrillator lead extraction
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bridge BalloonDevice
Also called Bridge Occlusion Balloon, Spectranetics
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Bridge Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 33 minutes (average time)
Secondary outcomes (4)
Time of Bridge Balloon Deployment
Time will be calculated in seconds starting from opening the Bridge Balloon Package up to full balloon deployment.
Measured: 33 minutes (average time)
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.
Measured: 1 year
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..
Measured: 1 year
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..
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for C.Surgical Procedure; CardiacStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Spectranetics Corporation
- Responsible party
- Sponsor
- Investigators
- Jude Clancy, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714153
- Sponsor's protocol ID
- 1602017220
- Status last verified
- May 2021
- First submitted
- 4 Mar 2016
- Last updated
- 14 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridge Occlusion Balloon Initial Use in Humans Study
- ClinicalTrials.gov ID
- NCT02714153
- Acronym / sponsor ID
- 1602017220
- Keywords
- Lead extraction, Superior Vena Cava Tear, Pacemaker/Defibrillator lead extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Spectranetics Corporation
- Study start
- Apr 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Posted 6 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the use of an occlusion balloon (Bridge™ Occlusion Balloon, Spectranetics) within the Superior Vena Cava in lead extraction patients.
Detailed description
This study will evaluate the use of an occlusion balloon (Bridge™ Occlusion Balloon, Spectranetics) within the Superior Vena Cava in lead extraction patients. This will be performed 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. Understanding these factors will help build a more robust clinical workflow with the goal of better patient outcomes in the case of an Superior Vena Cava injury. The images and data generated during this study can help in dissemination of the practical use knowledge to fellow lead extractors.
At the time of the protocol registration, the timeframe 12 months was entered, this was actually the anticipated length of the study at registration. The timeframe was corrected to 33 minutes (average time) at the time of results entry.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bridge Occlusion Balloon | Experimental | Device: Bridge BalloonBridge 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject age more than 18 years
- Lead extraction patients
Key exclusion criteria (7 listed)
- Superior Vena Cava occlusion or stenosis.
- Significant vegetation.
- Hemodynamic instability.
- Class IV heart failure
- Creatinine > 2.0mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bridge BalloonAlso: Bridge Occlusion Balloon, SpectraneticsThe 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. | Device | Bridge Occlusion Balloon |
Primary outcome
Number of Participants With Successful Balloon Occlusion of Superior Vena Cava
Time frame: 33 minutes (average time)
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.
4 secondary outcomes
Time of Bridge Balloon Deployment
Time frame: 33 minutes (average time)
Number of Participants With Changes in Heart Rate at One Year
Time frame: 1 year
Number of Participants With Changes in Blood Pressure at One Year
Time frame: 1 year
Number of Participants With Changes in SPO2 at One Year
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jude Clancy, MD principal investigator
Yale University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bridge Balloon in people with C.Surgical Procedure; Cardiac and Cardiac Dysrhythmia, run by Yale University at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Successful Balloon Occlusion of Superior Vena Cava (time frame: 33 minutes (average time)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.