Pacemaker Utilization and Ventricular Pacing in Patients Undergoing Trans-catheter Aortic Valve Replacement (TAVR)

NCT02994667 | Completed DMC

• 1 other identifier: 014-286
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the incidence (at 90-days) of ventricular pacing in patients undergoing permanent pacemaker placement after TAVR. As well as incidence (at 90-days) of atrioventricular block (AVB), intraventricular conduction delay (IVCD), bundle branch block (BBB), and rate histogram in patients undergoing permanent pacemaker placement after TAVR.

Conditions

Ventricular Flutter; Atrioventricular Block; Intraventricular Conduction Delay; Bundle Branch Block; Pacemaker Implantation

Keywords

Electrophysiology

Outcome Measures

Primary Outcomes (1)

• Incidence of Ventricular Pacing

  Incidence of Ventricular pacing post permanent pacemaker placement after TAVR as indicated by Pacemaker interrogation or remote monitoring system.

  7-90 days

Secondary Outcomes (1)

• Incidence of other conduction disturbances

  7-90 days

Study Arms (1)

Pacemaker After TAVR

The study cohort will comprise all consecutive patients who undergo permanent pacemaker placement for new conduction disturbances after TAVR at THHBP between 1/1/2015 and 12/31/2016.

Device: Permanent Pacemaker Placement

Interventions

Permanent Pacemaker Placement DEVICE

Pacemaker After TAVR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study cohort will comprise all consecutive patients who undergo permanent pacemaker placement for new conduction disturbances after TAVR at THHBP between 1/1/2015 and 12/31/2016 and will consist of up to 50 patients.

You may qualify if:

• Patients \> 18 years of age
• Patients undergoing Transcatheter Aortic Valve Replacement
• Indication for PPM including:
• Persistent 3rd degree AVB
• Transient 3rd degree AVB
• New Left BBB
• New bifascicular block
• New first degree AV block
• Any conduction disturbance determined by the investigator to be related to the TAVR procedure 4. Patients receiving post-TAVR PPM with one of the following devices
• a. Medtronic: i. ADAPTA DR -ADDR01 ii. ADAPTA L DR-ADDRL1 iii. ADVISA MRI-A2DR01 b. St. Jude Medical: i. Zypher 5820 ii. Zypher 5826 iii. Accent pm2110 iv. Accent pm2210 v. Assurity pm2240 vi. Endurity Pm2160

You may not qualify if:

• Pregnancy-Women of childbearing potential should have negative urine 'pregnancy test prior to enrollment
• Patients with implanted pacemaker
• Patients with implantable cardiac defibrillator
• Indication for post TAVR PPM not related to the procedure including sinus node dysfunction/sick sinus syndrome.
• Medically unable to provide consent

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

The Heart Hospital Baylor of Plano

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Ventricular Flutter; Atrioventricular Block; Bundle-Branch Block

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Block; Cardiac Conduction System Disease

Study Officials

• Brian Deville, MD

  The Heart Hospital Baylor of Plano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: December 16, 2016
• Study Start: January 1, 2015
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)