Conduction Disease After Transcatheter Aortic Valve Replacement

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Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation. CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System SMT Embolic Deflection CE Mark Trial DEFLECT I Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight Nitinol Circular Blade Functional Assessment In TAVI: FAITAVI CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. 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Evaluated Via Modern Ballistocardiography and Seismocardiography Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve The Plasma Serotonin and Aortic Stenosis: a Pilot Study. 18F-NaF Uptake and Aortic Stenosis Progression Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Ventricular Remodeling In Patients With Aortic Stenosis Assessed 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Brief Title

Conduction Disease After Transcatheter Aortic Valve Replacement

Official Title

Evaluation of Conduction Disease After Trans-catheter Aortic Valve Replacement

Brief Summary

      This is a prospective single center Cardiology department observational study. The study aim
      is to better understand the predictors of high grade conduction abnormalities associated with
      TAVR such that a more robust evidence-based and universal strategy to manage cardiac
      conduction disturbances in these patients, which has been elusive, can be developed.

Detailed Description

      TAVR is a very commonly performed procedure throughout the world; it has become standard of
      care as the treatment for aortic stenosis and is performed in hundreds of thousands of
      patients annually. TAVR affords patients therapies that prolong life and improve quality of
      life; furthermore, these therapies afford certain patients who are not candidates for
      surgical options hope for the future. Adults undergoing TAVR may suffer the complication of
      requiring a pacemaker after the procedure, in up to 30% of cases. Interventionalists still
      don't understand how to best predict this complication; in fact some patients that ultimately
      need a pacemaker don't get one after the procedure and some that get a pacemaker are found to
      ultimately not have really needed it. A better understanding of who does and who does not
      need pacemakers will help prevent complications of high grade block in those without
      pacemaker (death, syncope and trauma) and also the complications of unnecessary pacemaker
      implantation (infection, tricuspid regurgitation).

      Primary hypothesis: EP studies (EPS), which studies when performed before and after TAVR adds
      independent incremental value, above and beyond other parameters, for the prediction of
      high-grade heart block after TAVR. The goal is to understand conduction disease changes
      before and after TAVR, coupled with other patient and procedural factors that can help create
      a management algorithm for conduction disease after TAVR.

      Primary endpoint: to find correlation coefficients between a) absolute and delta values of
      various EPS findings, and b) clinical endpoint of high-grade conduction disease as diagnosed
      clinically, by ECG, by event monitor, or by interrogation of permanent pacemaker implanted
      after TAVR.

      Methods: Patients will receive EPS immediately before and after TAVR (while on the
      catheterization lab table for TAVR procedure) and then again the next day; this information
      will help determine whether the patient gets a pacemaker, a 30-day event monitor, or neither,
      and we will study which parameters obtained during the EPS, in addition to other
      known/suspected predictors of conduction disease after TAVR, best correlate with serious
      problems with the heart's electrical conduction system as determined by clinical follow-up.

      Anticipated findings: that the EPS findings add incremental and independent value in
      predicting which patients will develop high grade conduction disease.

Study Type

Interventional

Primary Outcome

High grade conduction disease post TAVR

Secondary Outcome

 death

Condition

Aortic Stenosis

Intervention

Electrophysiology Study

Study Arms / Comparison Groups

 Electrophysiology Study pre and Post TAVR
Description:  In all patient's undergoing TAVR after informed consent will undergo an electrophysiology study pre and post device deployment in order to determine the need for permanent pacemaker implantation or further testing/monitoring.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Diagnostic Test

Estimated Enrollment

200

Start Date

July 2020

Completion Date

June 1, 2022

Primary Completion Date

June 1, 2021

Eligibility Criteria

        Inclusion Criteria

          -  Signed and dated Informed Consent

          -  Patient that undergoes a TAVR

          -  Ability to complete functional assessments.

        Exclusion Criteria:

          -  Patients with pre-existing permanent pacemaker.

          -  Patient unwilling or unable to follow-up for necessary pre- and post-procedure
             clinical assessments.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Tiberio Frisoli, MD, 313-850-7336, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT04489095

Organization ID

Frisoli_13944

Responsible Party

Principal Investigator

Study Sponsor

Henry Ford Health System

Collaborators

 Medtronic

Study Sponsor

Tiberio Frisoli, MD, Principal Investigator, Henry Ford Health System

Verification Date

July 2020