Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT02714153
Study type Interventional
Source Yale University
Contact
Status Completed
Phase N/A
Start date April 2016
Completion date October 2017

See also
  Status Clinical Trial Phase
Recruiting NCT02908009 - A Case Control Study to Identify the Role of Epigenetic Regulation of Genes Responsible for Energy Metabolism and Mitochondrial Function in the Obesity Paradox in Cardiac Surgery
Completed NCT01998438 - Prospective Trial of Tranexamic Acid in Cardiac Surgery Phase 4
Completed NCT01805466 - Effects on Organ Damage and Surgical Outcome of a New Cardiopulmonary Pass System (EVADO) N/A
Completed NCT02658006 - Evaluation of Monitoring TECHNOlogies in the PERI-OPerative Care of Cardiac Surgical Patients N/A
Completed NCT02571920 - Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA) N/A
Completed NCT02267538 - Dexmedetomidine and Delirium in Patients After Cardiac Surgery Phase 4
Completed NCT02866825 - Studying Complement Inhibition in Complex Cardiac Surgery Phase 2
Completed NCT02513862 - Prospective Trial of Autologous Platelet Rich Plasma in Aortic Surgery N/A
Completed NCT02560519 - Albumin in Cardiac Surgery Phase 4
Recruiting NCT03884725 - Fibrinogen Concentrate In Children Cardiac Surgery 2 Phase 4
Recruiting NCT01879475 - Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery N/A
Completed NCT00598195 - Ketamine Pharmacokinetics in Children Having Heart Surgery N/A
Completed NCT02972684 - Cost-Utility Analysis of Management of Peri Operative Haemorrhage Following Cardiac Surgery With Cardiopulmonary Bypass N/A
Recruiting NCT02560285 - High-risk Patients in Cardiac Surgery Procedures: HiriSCORE N/A
Terminated NCT02793895 - Detection of Atrial Fibrillation After Cardiac Surgery N/A
Active, not recruiting NCT03343418 - Effects of Prophylactic Desmopressin on Blood Coagulation Parameters in Heart Valve Surgery Phase 4
Recruiting NCT03469440 - Goal Directed Therapy Aiming to Optimise Oxygen Central Venous Saturation in Children Undergoing Cardiac Surgery N/A
Recruiting NCT03882593 - Blood Cell Adhesion to Arterial Filters During Cardiac Surgery
Withdrawn NCT02119806 - Decreasing the Incidence of Delirium After Cardiac Surgery Phase 4
Completed NCT02831907 - Portal Flow Pulsatility as a Risk Factor for Acute Kidney Injury After Cardiac Surgery N/A