Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective Arm of Conduct - Edwards SAPIEN3 PPI Registry (Conduct-pro)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03715894
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin

Brief Summary:

There are procedure related risk factors for permanent pacemaker implantation (PPI) that can be identified and assessed in a prospective cohort of 300 patients at high risk for PPI

Prospective, multicenter, European registry in patients at high risk for PPI undergoing TAVI with the Edwards SAPIEN 3 valve. Additional assessment of calcification using a CT data core lab. Statistical analysis of the dataset obtained with respect to the objectives of the registry.


Condition or disease Intervention/treatment
Aortic Valve Stenosis AV Block Bundle-Branch Block Procedure: transcatheter valve implantation

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Edwards SAPIEN 3 PPI Registry - A Retrospective Survey and Prospective Identification of Procedure Related Variables Associated With Permanent Pacemaker Implantation in Patients Receiving an Edwards SAPIEN 3 Valve
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020


Group/Cohort Intervention/treatment
Patients with aortic stenosis
Patients receiving Edwards SAPIEN 3 aortic transcatheter valve Implantation, who are with a high risk for PPI
Procedure: transcatheter valve implantation
aortic transcatheter valve implantation using Edwards SAPIEN 3 valve




Primary Outcome Measures :
  1. Occurence of permanent pacemaker implantation after TAVI in high risk patients [ Time Frame: 1 year ]
    Need for permanent pacemaker implantation after TAVI in high risk patients.


Secondary Outcome Measures :
  1. Implantation depth [ Time Frame: up to 30 days after intervention ]
    Measurement in peri-interventional aortic angiograms. Mean implantation depth (% ventricular part of the stent frame)

  2. Valve sizing [ Time Frame: up to 30 days after intervention ]
    Measurement of aorta in pre‐operative contrast multislice computed tomographic Images, compared to the implanted valve sizing. Percentage of oversizing will be calculated using the formula (nominal prosthesis area/multislice computed tomographic area ‐ 1) x 100

  3. Dilatation [ Time Frame: 1 year ]
    Ratio in patients, who get a dilatation before or at intervention as well as thereafter (discharge, FU)

  4. Expiration data [ Time Frame: 2 years ]
    cause of death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing transfemoral transcatheter valve implantation with the SAPIEN 3 valve with at least one identified risk factor for PPI
Criteria

Inclusion Criteria:

  • Patients undergoing transfemoral SAPIEN 3 implantation because of aortic stenosis,
  • at least 1 of the identified risk factors from the retrospective part to ensure a minimum risk of 33% for PPI (presumed: pre‐existing conduction disturbance, aortic valve calcification, heavily calcified LVOT, RBBB, persistent complete heart blocks, QRS duration or short membranous septum,to be confirmed);

Exclusion Criteria:

  • exclusion of patients with prior pacemaker,
  • with indications for pacemaker implantation prior to TAVI
  • valve in valve implantation or
  • without informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715894


Contacts
Layout table for location contacts
Contact: Maren Froehlich +49 441 92517813 maren.froehlich@ippmed.de
Contact: Peter Bramlage, Prof. Dr. +49 3379 3147890 peter.bramlage@ippmed.de

Locations
Layout table for location information
Germany
University Clinic Tübingen, Department of Internal Medicine III Not yet recruiting
Tübingen, Baden-Württemberg, Germany, 72076
Contact: Tobias Geisler, Prof    +49 7071 2982712    tobias.geisler@med.uni-tuebingen.de   
University Clinic Ulm, Department of Internal Medicine II Not yet recruiting
Ulm, Baden-Württemberg, Germany, 89073
Contact: Jochen Wöhrle, Prof.    +49 731 50045047    jochen.woehrle@uniklinik-ulm.de   
Herz‐ und Diabeteszentrum Recruiting
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
Contact: Tanja Rudolph, Prof.       tk.rudolph@me.com   
Netherlands
Academisch Medisch Centrum (AMC) Recruiting
Amsterdam, Netherlands
Contact: Jan Baan, MD PhD    + 31 6 23426758    j.baan@amc.uva.nl   
Sweden
Dept of Cardiology, Linköping University Hospital, Not yet recruiting
Linköping,, Sweden, 58183
Contact: Niels Erik Nielsen, Dr.    +46 10 1032110    niels.erik.nielsen@regionostergotland.se   
Contact: Jacek Baranowski, Dr.       jacek.baranowski@regionostergotland.se   
Sponsors and Collaborators
Institut für Pharmakologie und Präventive Medizin
Edwards Lifesciences
Investigators
Layout table for investigator information
Principal Investigator: Tobias Geisler, Prof. University Clinic Tübingen, Tübingen, Germany - Department of Internal Medicine III

Publications:

Layout table for additonal information
Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT03715894    
Other Study ID Numbers: Conduct prospective
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no IPD will be made available

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut für Pharmakologie und Präventive Medizin:
Transcatheter aortic valve implantation
Pacemaker
Aortic valve calcification
PPI
Additional relevant MeSH terms:
Layout table for MeSH terms
Aortic Valve Stenosis
Bundle-Branch Block
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Heart Block
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes