Prospective Arm of Conduct - Edwards SAPIEN3 PPI Registry

NCT03715894 | Completed

• 1 other identifier: Conduct prospective
• Study Type: observational
• Target: 300
• Locations: 3 countries
• Sites: 5

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.

Conditions

Aortic Valve Stenosis; AV Block; Bundle-Branch Block

Keywords

Transcatheter aortic valve implantation; Pacemaker; Aortic valve calcification; PPI

Outcome Measures

Primary Outcomes (1)

• Occurence of permanent pacemaker implantation after TAVI in high risk patients

  Need for permanent pacemaker implantation after TAVI in high risk patients.

  1 year

Secondary Outcomes (4)

• Implantation depth

  up to 30 days after intervention

• Valve sizing

  up to 30 days after intervention

• Dilatation

  1 year

• Expiration data

  2 years

Study Arms (1)

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

Interventions

transcatheter valve implantation PROCEDURE

aortic transcatheter valve implantation using Edwards SAPIEN 3 valve

Patients with aortic stenosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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);

You may not qualify if:

• with indications for pacemaker implantation prior to TAVI
• valve in valve implantation or
• without informed consent

Sponsors & Collaborators

• Institut für Pharmakologie und Präventive Medizin: lead
• Edwards Lifesciences: collaborator

Study Sites (5)

University Clinic Tübingen, Department of Internal Medicine III

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

University Clinic Ulm, Department of Internal Medicine II

Ulm, Baden-Wurttemberg, 89073, Germany

Location

Herz- und Diabeteszentrum

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Academisch Medisch Centrum (AMC)

Amsterdam, Netherlands

Location

Dept of Cardiology, Linköping University Hospital,

Linköping, 58183, Sweden

Location

Related Publications (9)

• Bob-Manuel T, Nanda A, Latham S, Pour-Ghaz I, Skelton WP 4th, Khouzam RN. Permanent pacemaker insertion in patients with conduction abnormalities post transcatheter aortic valve replacement: a review and proposed guidelines. Ann Transl Med. 2018 Jan;6(1):11. doi: 10.21037/atm.2017.10.21.

  PMID: 29404357 BACKGROUND

• De Torres-Alba F, Kaleschke G, Diller GP, Vormbrock J, Orwat S, Radke R, Reinke F, Fischer D, Reinecke H, Baumgartner H. Changes in the Pacemaker Rate After Transition From Edwards SAPIEN XT to SAPIEN 3 Transcatheter Aortic Valve Implantation: The Critical Role of Valve Implantation Height. JACC Cardiovasc Interv. 2016 Apr 25;9(8):805-813. doi: 10.1016/j.jcin.2015.12.023. Epub 2016 Mar 23.

  PMID: 27017367 BACKGROUND

• Maeno Y, Abramowitz Y, Kawamori H, Kazuno Y, Kubo S, Takahashi N, Mangat G, Okuyama K, Kashif M, Chakravarty T, Nakamura M, Cheng W, Friedman J, Berman D, Makkar RR, Jilaihawi H. A Highly Predictive Risk Model for Pacemaker Implantation After TAVR. JACC Cardiovasc Imaging. 2017 Oct;10(10 Pt A):1139-1147. doi: 10.1016/j.jcmg.2016.11.020. Epub 2017 Apr 12.

  PMID: 28412434 BACKGROUND

• Tarantini G, Mojoli M, Purita P, Napodano M, D'Onofrio A, Frigo A, Covolo E, Facchin M, Isabella G, Gerosa G, Iliceto S. Unravelling the (arte)fact of increased pacemaker rate with the Edwards SAPIEN 3 valve. EuroIntervention. 2015 Jul;11(3):343-50. doi: 10.4244/EIJY14M11_06.

  PMID: 25405801 BACKGROUND

• Mauri V, Reimann A, Stern D, Scherner M, Kuhn E, Rudolph V, Rosenkranz S, Eghbalzadeh K, Friedrichs K, Wahlers T, Baldus S, Madershahian N, Rudolph TK. Predictors of Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement With the SAPIEN 3. JACC Cardiovasc Interv. 2016 Nov 14;9(21):2200-2209. doi: 10.1016/j.jcin.2016.08.034.

  PMID: 27832845 BACKGROUND

• Gonska B, Seeger J, Kessler M, von Keil A, Rottbauer W, Wohrle J. Predictors for permanent pacemaker implantation in patients undergoing transfemoral aortic valve implantation with the Edwards Sapien 3 valve. Clin Res Cardiol. 2017 Aug;106(8):590-597. doi: 10.1007/s00392-017-1093-2. Epub 2017 Mar 10.

  PMID: 28283746 BACKGROUND

• Husser O, Pellegrini C, Kessler T, Burgdorf C, Thaller H, Mayr NP, Kasel AM, Kastrati A, Schunkert H, Hengstenberg C. Predictors of Permanent Pacemaker Implantations and New-Onset Conduction Abnormalities With the SAPIEN 3 Balloon-Expandable Transcatheter Heart Valve. JACC Cardiovasc Interv. 2016 Feb 8;9(3):244-254. doi: 10.1016/j.jcin.2015.09.036.

  PMID: 26847116 BACKGROUND

• Schwerg M, Fulde F, Dreger H, Poller WC, Stangl K, Laule M. Optimized Implantation Height of the Edwards SAPIEN 3 Valve to Minimize Pacemaker Implantation After TAVI. J Interv Cardiol. 2016 Aug;29(4):370-4. doi: 10.1111/joic.12302. Epub 2016 May 31.

  PMID: 27240558 BACKGROUND

• Fujita B, Kutting M, Seiffert M, Scholtz S, Egron S, Prashovikj E, Borgermann J, Schafer T, Scholtz W, Preuss R, Gummert J, Steinseifer U, Ensminger SM. Calcium distribution patterns of the aortic valve as a risk factor for the need of permanent pacemaker implantation after transcatheter aortic valve implantation. Eur Heart J Cardiovasc Imaging. 2016 Dec;17(12):1385-1393. doi: 10.1093/ehjci/jev343. Epub 2016 Jan 12.

  PMID: 26758411 BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis; Atrioventricular Block; Bundle-Branch Block; Aortic Valve, Calcification of

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Heart Block; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Tobias Geisler, Prof.

  University Clinic Tübingen, Tübingen, Germany - Department of Internal Medicine III

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 23, 2018
• Study Start: December 1, 2018
• Primary Completion: October 15, 2022
• Study Completion: March 30, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); NL (1); SE (1)