Clinical Outcomes in Fenestrated Extra-Cardiac Fontan in Low Preoperative Risk Profiles

NCT03503032 | Completed DMC

• 1 other identifier: 1
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of fenestration benefit in Extra-cardiac total cavo-pulmonary connection (Fontan procedure) in single ventricle anomaly, comparing clinical outcomes of patients with low preoperative risk profiles in prospective study

Conditions

Fontan Procedure

Keywords

Extracardiac Fontan; Total cavo-pulmonary connection; Fenestrated; Congenital heart defects; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Duration of chest tube drainage

  Total duration of days patient has been having chest tube inserted in his pleural cavities

  through study completion, an average of 1 year

Secondary Outcomes (7)

• Length of hospital stay

  through study completion, an average of 1 year

• Length of intensive care unit stay

  through study completion, an average of 1 year

• Total amount of chest tube drainage

  through study completion, an average of 1 year

• Number of additional procedures

  through study completion, an average of 1 year

• Stroke

  through study completion, an average of 1 year

Study Arms (2)

Fenestrated

Standard extracardiac fontan undergoing Fontan fenestration creation

Procedure: Extracardiac Fontan; Procedure: Fontan fenestration

Non fenestrated

Standard extracardiac fontan without fenestration

Procedure: Extracardiac Fontan

Interventions

Extracardiac Fontan PROCEDURE

Extracardiac Fontan (Total cavo-pulmonary connection) will be constructed with a tube graft from the inferior vena cava to the pulmonary artery \[applied to both arms\]

Also known as: Extracardiac Total cavo-pulmonary connection

Fenestrated; Non fenestrated

Fontan fenestration PROCEDURE

Fontan fenestration created as a single 3 to 6mm communication between fontan channel and pulmonary venous atrium \[Fenestrated arm\]

Fenestrated

Eligibility Criteria

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

Study Population

All patients referred to King Faisal Specialist Hospital and Research Center in Jeddah for an elective (Fontan) Total cavopulmonar connection procedure at the period of the study, who demonstrated a standard risk profile.

You may qualify if:

• This study will includeall patients referred for an elective TCPC procedure at the period of the study, who demonstrated a standard risk profile
• Preoperative evaluation consisted of ECG, transthoracic echocardiogram, and complete cardiac catheterization.
• Patients with the following parameters will be eligible for enrollment in the study:
• Sinus Rhythm
• Atriovnetricular valve regurgitation not more than mild
• Aortic (neoaortic) valve regurgitation not more than mild
• Normal systolic dominant ventricle function
• Mean pulmonary artery pressure not more than 15 mmHg (measured directly or estimated by pulmonary vein wedge pressure)
• Pulmonary vascular resistance not more than 2 woods unit
• End diastolic ventricular filling pressure not more than 8 mm Hg
• Patients with pulmonary artery distortion, stenosis or thrombus requiring surgical or interventional additional procedures before or during the Fontan operation.
• Pacemaker insertion before or during Fontan operation.
• Significant pulmonary arteriovenous malformations (AVMs) rendering fenestration potentially a cause of excessive cyanosis.
• Patients for whom the cardiology/cardiac surgery case conference decision is strongly in favor of fenestration for any other cause.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

KFSHRC

Jeddah, Westren, Saudi Arabia

Location

Related Publications (12)

• Fontan F, Baudet E. Surgical repair of tricuspid atresia. Thorax. 1971 May;26(3):240-8. doi: 10.1136/thx.26.3.240.

  PMID: 5089489 BACKGROUND

• de Leval MR, Kilner P, Gewillig M, Bull C. Total cavopulmonary connection: a logical alternative to atriopulmonary connection for complex Fontan operations. Experimental studies and early clinical experience. J Thorac Cardiovasc Surg. 1988 Nov;96(5):682-95.

  PMID: 3184963 BACKGROUND

• Amodeo A, Galletti L, Marianeschi S, Picardo S, Giannico S, Di Renzi P, Marcelletti C. Extracardiac Fontan operation for complex cardiac anomalies: seven years' experience. J Thorac Cardiovasc Surg. 1997 Dec;114(6):1020-30; discussion 1030-1. doi: 10.1016/S0022-5223(97)70016-3.

  PMID: 9434697 BACKGROUND

• d'Udekem Y, Iyengar AJ, Cochrane AD, Grigg LE, Ramsay JM, Wheaton GR, Penny DJ, Brizard CP. The Fontan procedure: contemporary techniques have improved long-term outcomes. Circulation. 2007 Sep 11;116(11 Suppl):I157-64. doi: 10.1161/CIRCULATIONAHA.106.676445.

  PMID: 17846297 BACKGROUND

• Bando K, Turrentine MW, Park HJ, Sharp TG, Scavo V, Brown JW. Evolution of the Fontan procedure in a single center. Ann Thorac Surg. 2000 Jun;69(6):1873-9. doi: 10.1016/s0003-4975(00)01316-3.

  PMID: 10892940 BACKGROUND

• Azakie A, Russell JL, McCrindle BW, Van Arsdell GS, Benson LN, Coles JG, Williams WG. Anatomic repair of anomalous left coronary artery from the pulmonary artery by aortic reimplantation: early survival, patterns of ventricular recovery and late outcome. Ann Thorac Surg. 2003 May;75(5):1535-41. doi: 10.1016/s0003-4975(02)04822-1.

  PMID: 12735576 BACKGROUND

• de Leval MR, Dubini G, Migliavacca F, Jalali H, Camporini G, Redington A, Pietrabissa R. Use of computational fluid dynamics in the design of surgical procedures: application to the study of competitive flows in cavo-pulmonary connections. J Thorac Cardiovasc Surg. 1996 Mar;111(3):502-13. doi: 10.1016/s0022-5223(96)70302-1.

  PMID: 8601964 BACKGROUND

• Bridges ND, Lock JE, Castaneda AR. Baffle fenestration with subsequent transcatheter closure. Modification of the Fontan operation for patients at increased risk. Circulation. 1990 Nov;82(5):1681-9. doi: 10.1161/01.cir.82.5.1681.

  PMID: 2225370 BACKGROUND

• Bridges ND, Mayer JE Jr, Lock JE, Jonas RA, Hanley FL, Keane JF, Perry SB, Castaneda AR. Effect of baffle fenestration on outcome of the modified Fontan operation. Circulation. 1992 Dec;86(6):1762-9. doi: 10.1161/01.cir.86.6.1762.

  PMID: 1451248 BACKGROUND

• Hsu DT, Quaegebeur JM, Ing FF, Selber EJ, Lamour JM, Gersony WM. Outcome after the single-stage, nonfenestrated Fontan procedure. Circulation. 1997 Nov 4;96(9 Suppl):II-335-40.

  PMID: 9386120 BACKGROUND

• Thompson LD, Petrossian E, McElhinney DB, Abrikosova NA, Moore P, Reddy VM, Hanley FL. Is it necessary to routinely fenestrate an extracardiac fontan? J Am Coll Cardiol. 1999 Aug;34(2):539-44. doi: 10.1016/s0735-1097(99)00228-4.

  PMID: 10440170 BACKGROUND

• Airan B, Sharma R, Choudhary SK, Mohanty SR, Bhan A, Chowdhari UK, Juneja R, Kothari SS, Saxena A, Venugopal P. Univentricular repair: is routine fenestration justified? Ann Thorac Surg. 2000 Jun;69(6):1900-6. doi: 10.1016/s0003-4975(00)01247-9.

  PMID: 10892944 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Abdulbadee Bogis, MD

  King Faisal Specialist Hospital & Research Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 19, 2018
• Study Start: April 1, 2023
• Primary Completion: April 12, 2023
• Study Completion: April 12, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

SA (1)