CHSS Center for Research and Quality: LVOTO: Critical Left Ventricular Outflow Tract Obstruction Study

LVOTO: Critical Left Ventricular Outflow Tract Obstruction Study

Enrollment in this study has been suspended. Please see the CHSS Memo LVOTO Enrollment Pause document below:

Optimal Management of Critical Left Ventricular Outflow Tract Obstruction:
A Congenital Heart Surgeons' Society Study (LVOTO Study)
OPERATIONS MEMORANDUM LVOTO #1

To:	LVOTO Investigators and Coordinators
From:	Congenital Heart Surgeons� Society Center for Research and Quality (CHSS Center for Research and Quality) in consultation with the Congenital Heart Surgeons� Society (CHSS) Research Committee
Re:	LVOTO hold on enrollment
Date:	December 12, 2019

This memorandum is to inform you that we are temporarily pausing enrollment in the LVOTO study starting Saturday December 21, 2019. Please follow-up with any patients you have approached for this study but do not approach any patients after Friday December 20, 2019.

The Research Committee has decided, based on information provided by the CHSS Center for Research and Quality, to put a hold on enrollment in this study. We currently have over 1,200 patients enrolled. The hold on enrollment will allow the CHSS Center for Research and Quality to catch up on the backlog for data entry in this cohort.

Please submit all required enrollment data to the CHSS Center for Research and Quality as soon as possible so that we may confirm eligibility of these patients.

The LVOTO study is NOT closing. Annual follow-up of all currently enrolled patients will continue so please keep your IRB ACTIVE/OPEN. The CHSS Center for Research and Quality will notify you when new enrollment will be open again.

Please contact CHSS Center for Research and Quality Operations Manager, Sunita O'Shea if you have any questions.

Thank you

Dr. William DeCampli
Managing Director CHSS Center for Research and Quality

Study Protocol

Current Study Protocol (September 22 2015)

Study Protocol (with track changes) if needed for IRB/REB Submissions:

Study Protocol (Track Changes: September 22 2015)

Study Protocol (Track Changes: June 30 2015)

Protocol Amendment Summary (if needed for IRB/REB submissions):

Protocol Amendment Summary (Protocol Version Date: 22 Sep 2015)

Protocol Amendment Summary (Protocol Version Date: 30 Jun 2015)

Enrollment & Registration

Patient Enrollment Form (November 19, 2018)
Patient Demographic Information Form (generic) (November 30, 2015)

Approval Letter

Study Re-approval Letter at The Hospital for Sick Children, Toronto (January 17, 2019)

Consent & Assent and Cover Letters

For Parent/Guardian:

Parent/Guardian Cover Letter with current Consent-Assent (for reconsenting) (generic) (December 9, 2015)

Parent/Guardian Consent Form (February 29, 2016)

Assent Form (February 29, 2016)

For Patient/Adult:

Patient/Adult Cover Letter with current Consent-Assent (for reconsenting) (generic) (December 9, 2015)

Patient/Adult Consent Form (February 29, 2016)

Data Collection Forms

To be abstracted at the CHSS Center for Research and Quality, Toronto
1. General Forms
  - Data Collection Forms - General (June 29, 2015)
  - Data Collection Forms - Arch Obstruction (March 15, 2016)
  - Contact Information Form (March 15, 2016)
  - Administration Form (March 15, 2016)
  - Timing of Stage 2 - Initial Variable Collection (May 31, 2016)
  - Timing of Stage 2 - Traditional and Hybrid Approaches (May 31, 2016)
  - Timing of Stage 2 - Repeated Measures Post Norwood to Post Stage 2 (May 31,2016)