Clinical Trials Logo

Clinical Trial Summary

In addition to conventional heart valve surgery (HVS) via full-sternotomy, which is still the most prevalent therapeutic strategy to address valvular heart disease (VHD), minimally-invasive approaches evolved as safe alternatives, resulting in lower postoperative ventilation times, transfusion rates and shorter in-hospital stay. Femoral artery cannulation is traditionally performed via surgical cutdown to establish cardiopulmonary bypass during minimally-invasive HVS. To avoid groin incision associated infection and lymphocele formation, and further minimize surgical trauma, the use of percutaneous cannulation including novel endovascular closure devices increases as an alternative but remains to be investigated. The Percutaneous peRipheral cannulatiOn for Minimally-InvaSive heart valve surgEry (PROMISE) registry aims to elucidate the safety, feasibility, and effectiveness of newly developed vascular closure devices during minimally-invasive HVS. Acute intra- and perioperative complications will be evaluated according to modified definitions of the Valve Academic Research Consortium (VARC)-3. In addition, based on the initial results, the comparison of percutaneous cannulation with conventional surgical cut-down techniques is planned.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05961150
Study type Observational
Source Universitätsklinikum Hamburg-Eppendorf
Contact Jonas Pausch, MD
Phone +49 40 7410 0
Email j.pausch@uke.de
Status Recruiting
Phase
Start date August 1, 2023
Completion date December 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04149600 - Identification of Genetic Causes of Calcific Aortic Valve Disease
Recruiting NCT06001489 - The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy N/A
Not yet recruiting NCT04430972 - Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)
Completed NCT02467062 - Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease. N/A
Not yet recruiting NCT02221921 - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI N/A
Terminated NCT02128841 - Comparison of Antithrombotic Treatments After Aortic Valve Replacement. Rivaroxaban: A New Antithrombotic Treatment for Patients With Mechanical Prosthetic Aortic Heart Valve. Phase 2
Active, not recruiting NCT01194362 - A Study to Identify Differences in Gene Expression in Patients With Bicuspid and Tricuspid Valve Disease
Not yet recruiting NCT05975567 - Deploying Novel Imaging Modalities Towards a Three-dimensional (3D) CARDIOvascular PATHology
Recruiting NCT06025149 - The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases
Completed NCT05082337 - The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures N/A
Completed NCT05193760 - Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery
Not yet recruiting NCT05941455 - A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve N/A
Active, not recruiting NCT04950192 - Philips Intracardiac Echocardiography (ICE) Clinical Registry
Active, not recruiting NCT03924661 - SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
Completed NCT04073875 - 18F-GP1 PET-CT to Detect Bioprosthetic Aortic Valve Thrombosis
Recruiting NCT03121053 - Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement Phase 4
Completed NCT02000544 - Clinical Evaluation of a Modular Extracorporeal Circulation Circuit N/A
Completed NCT02688153 - EDWARDS INTUITY Valve System CADENCE Study N/A
Completed NCT02981004 - PAR I - Patient-to-Annulus Relation I
Recruiting NCT06126367 - Assessment of Lipoprotein(a) and Endogenous Fibrinolysis in Atherosclerotic Cardiovascular Disease/Aortic Valve Disease