Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Edwards SAPIEN 3 PPI Registry (Conduct)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03497611
Recruitment Status : Completed
First Posted : April 13, 2018
Last Update Posted : March 25, 2019
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin

Brief Summary:

There are patient related risk factors for PPI that can be identified and assessed in retrospective pooling of 1000+ TAVI patient datasets.

Retrospective pooling of 6 datasets already available at participating centres (4 sites in Germany, 1 in Zwolle / The Netherlands, 1 in Linköping / Sweden).

Additional assessment of calcifications using a CT data core lab. Statistical analysis of the obtained dataset 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

Detailed Description:

Permanent pacemaker implantation is a widely recognized clinical event associated with TAVI becoming evident within a few days after the procedure.

While a number of registries have documented the rates of PPI with different valves, much less evidence has been provided for 1) patient based characteristics (e.g. RBBB etc.) affecting the likelihood of PPI and for 2) procedural variables (e.g. implantation depth, valve size etc.) that should be considered to perform an as safe and minimal invasive procedure as possible.

Prior research To date there are 7 published reports on pacemaker rates and predictors associated with the use of the Edwards SAPIEN 3 THV (see Table). These studies suggest that the need for pacemaker implantation in single centers ranges between 14.4 and 20.4% derived from patient numbers between 131 and 335. These analyses resulted in the identification of pre-existing conduction disturbance / aortic valve calcification as patient related and implantation depth /oversizing as procedure related variables associated with Edwards SAPIEN 3 THV TAVI. Furthermore a scoring algorithm for patient related factors has been proposed from a dataset of 240 patients to predict the likelihood of PPI after THV .

Limitations of prior research Current evidence though is limited by patient numbers versus event rates (with a max. of 62 PPI considered in any of the available datasets) resulting in a limited power in multivariable analyses, the single center design of these ventures, the lack of a consistent definition of variables potentially associated and the unexplained differences in the number and type of variables identified.

Aims For this reason the investigators consider it necessary to 1) to retrospectively pool data from all of these 7 datasets to arrive at a more comprehensive picture of patient related variables (retrospective part I), to 2) assess procedural variables in a prospective multicenter registry (prospective part II) and 3) to potentially validate the identified variables in a future prospective cohort.


Layout table for study information
Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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 : April 30, 2018
Actual Primary Completion Date : November 3, 2018
Actual Study Completion Date : March 3, 2019


Group/Cohort Intervention/treatment
Patients with aortic stenosis
Patients receiving Edwards SAPIEN 3 Transcatheter aortic valve implantation
Procedure: transcatheter valve implantation
aortic transcatheter valve implantation using Edwards SAPIEN 3 valve




Primary Outcome Measures :
  1. occurence of PPI after TAVI [ Time Frame: 30 days ]
    need for permanent pacemaker implantation after TAVI


Secondary Outcome Measures :
  1. Timing of PPI [ Time Frame: 30 days ]
    Time interval after TAVI until PPI in days

  2. Indications for PPI [ Time Frame: 30 days ]

    possible reasons to implant a PP:

    • 1° AV block
    • complete RBBB
    • complete LBBB
    • QRS duration prolonged
    • LVOT calcium volume below the left and right cusp
    • etc



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 that already underwent transfemoral transcatheter valve implantation with the SAPIEN 3 valve
Criteria

Inclusion Criteria:

  • Patients that already underwent Edwards SAPIEN 3 implantation because of aortic stenosis

Exclusion Criteria:

  • Patients with prior pacemaker or intended valve in valve implantation

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): NCT03497611


Locations
Layout table for location information
Germany
University Clinic Tübingen, Department of Internal Medicine III
Tübingen, Baden-Württemberg, Germany, 72076
University Clinic Ulm, Department of Internal Medicine II
Ulm, Baden-Württemberg, Germany, 89073
Herzzentrum, Universität Köln
Cologne, Nordrhein-Westfalen, Germany, 50937
Universitätsklinikum Münster, Klinik und Poliklinik für Erwachsene mit angeborenen und erworbenen Herzfehlern
Münster, Nordrhein-Westfalen, Germany, 48149
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

Layout table for additonal information
Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT03497611     History of Changes
Other Study ID Numbers: Conduct
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 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