PROMISE: Percutaneous peRipheral cannulatiOn for Minimally-InvaSive Heart Valve surgEry

Aortic Valve Disease Clinical Trial

Official title:

PROMISE: Percutaneous peRipheral cannulatiOn for Minimally-InvaSive Heart Valve surgEry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05961150
• Other study ID #: PROMISE
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Jonas Pausch, MD
• Phone: +49 40 7410 0
• Email: j.pausch[@]uke.de
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Retrospective analysis of all patients undergoing minimally-invasive heart valve surgery using novel endovascular closure devices for percutaneous cannulation within 6 high-volume heart valve centres in Germany.

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Aortic Valve Disease
• Heart Valve Diseases
• Mitral Valve Disease
• Tricuspid Valve Disease

Locations

Country	Name	City	State
Germany	University Heart and Vascular Center Hamburg, University Medical Centre Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Access site related vascular complications.	Incidence (number of) of access site related vascular complications, according to modified Valve Academic Research Consortium 3 (VARC 3) criteria.	Date of operation (day 0) until 30 days after operation (day 30).
Primary	All-cause mortality.	Incidence (number of) of death from any cause.	Date of operation (day 0) until 30 days after operation (day 30).
Primary	Cardiovascular mortality.	Incidence (number of) of cardiovascular death, defined as death attributable to myocardial ischemia and infarction, heart failure, cardiac arrest because of other or unknown cause, or cerebrovas-cular accident.	Date of operation (day 0) until 30 days after operation (day 30).