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

May 15, 2024 updated by: Universitätsklinikum Hamburg-Eppendorf

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jonas Pausch, MD
Phone Number: +49 40 7410 0
Email: j.pausch@uke.de

Study Contact Backup

Name: Lenrad Conradi, Prof
Phone Number: +49 40 7410 0
Email: l.conradi@uke.de

Study Locations

Germany
- - Hamburg, Germany
    - Recruiting
    - University Heart and Vascular Center Hamburg, University Medical Centre Hamburg-Eppendorf
    - Contact:
      
      Jonas Pausch, MD
      
      Phone Number: +49 40 7410 0
      
      Email: j.pausch@uke.de
    - Contact:
      
      Lenard Conradi, Prof
    - Principal Investigator:
      
      Lenard Conradi, Prof
    - Principal Investigator:
      
      Jonas Pausch, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

The Percutaneous peRipheral cannulatiOn for Minimally-InvaSive heart valve surgEry (PROMISE) registry aims to analyse the perioperative outcome of percutaneous peripheral cannulation techniques and their implications during minimally-invasive heart valve surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Access site related vascular complications. Time Frame: Date of operation (day 0) until 30 days after operation (day 30).	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).
All-cause mortality. Time Frame: Date of operation (day 0) until 30 days after operation (day 30).	Incidence (number of) of death from any cause.	Date of operation (day 0) until 30 days after operation (day 30).
Cardiovascular mortality. Time Frame: Date of operation (day 0) until 30 days after operation (day 30).	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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

July 17, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

PROMISE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.