Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach

Tricuspid Valve Insufficiency Clinical Trial

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Official title:

Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach At The Time Of Left- Sided Valve Surgery. A Prospective Randomized Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03278418
• Other study ID #: ESREFO 32
• Status: Not yet recruiting
• Phase: N/A
• First received: August 31, 2017
• Last updated: September 7, 2017
• Start date: September 2017
• Est. completion date: October 2021

Study information

• Verified date: September 2017
• Source: Ettore Sansavini Health Science Foundation
• Contact: Mauro Del Giglio, MD
• Phone: +390545217445
• Email: mdelgiglio[@]gvmnet.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients elected to undergo any type of left-sided valve surgery (either repair or replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective left-sided valve replacement or repair with or without concomitant tricuspid valve repair in a 1:1 fashion, using a blocked randomization scheme balanced within center.

Description:

The present study is designed as a prospective, multicentre, multinational, randomized, 2-arm parallel group trial. Participating centres are selected based on previous experience with the surgical technique and standardised echo imaging. Each center is expected to contribute 70 patients over a 12 months enrolment period.

Patients elected to undergo any type of left-sided valve surgery (either repair or replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective left-sided valve replacement or repair with or without concomitant tricuspid valve repair in a 1:1 fashion, using a blocked randomization scheme balanced within center.

After discharge patients will be assessed at 1, 12, 24 and 36 months after surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: October 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients undergoing left-sided valve surgery for left-sided valve disease

• Presence of non-severe TR and tricuspid annular dilation (>40 mm or > 21 mm/m2 BSA) determined by echocardiography

• Age = 18 years

• Capability to sign Informed Consent and Release of Medical Information forms

Exclusion Criteria:

• Preoperative severe TR

• Structural / organic tricuspid valve disease

• Tricuspid annulus =40 mm (or = 21 mm/m2 BSA) on preoperative TTE

• Implanted pacemaker or defibrillator, where the leads cross the tricuspid valve from the right atrium into the RV

• Any type of reoperative surgery

• Concomitant cardiac surgery other than atrial fibrillation correction surgery (pulmonary vein isolation, Maze procedure, left atrial appendage closure) or closure of patent foramen ovale or atrial septal defect (for example, concomitant coronary artery bypass graft or aortic surgery)

• Cardiogenic shock at the time of randomization

• ST-elevated myocardial infarction requiring intervention within 7 days prior to randomization

• Evidence of cirrhosis or hepatic synthetic failure

• Severe, irreversible pulmonary hypertension in the judgment of the investigator

• Pregnancy at the time of randomization

• Any concurrent disease with life expectancy < 1 year

• Patient unable or unwilling to provide informed consent

Related Conditions & MeSH terms

• Tricuspid Valve Insufficiency

Intervention

Procedure:
• Tricuspid Valve Repair
It will be performed according to the surgeon preference
• Left-sided valve surgery
It will be performed according to the surgeon preference

Locations

Country	Name	City	State
Italy	Maria Cecilia Hospital	Cotignola	Ravenna
Italy	IRCCS Opsedale San Raffaele	Milano
Italy	IRCCS Policlinico San Donato	Milano
Italy	Maria Eleonora Hospital	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
Ettore Sansavini Health Science Foundation

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant TR (moderate or severe)	To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as moderate (5-10 cm2) or severe (>10 cm2).	3 years
Secondary	Significant TR (moderate or severe)	To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as moderate (5-10 cm2) or severe (>10 cm2).	1 and 2 years
Secondary	Mild TR	To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as non severe (=10 cm2) or mild (<5 cm2).	1,2 and 3 years
Secondary	Overall TR (mild, moderate, severe)	To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as non severe (=10 cm2; mild <5 cm2, moderate = 5-10 cm2), or severe (>10 cm2).	1, 2 and 3 years
Secondary	RV function	To compare the effect of the 2 strategies for non-severe TR described above on the evaluation of reverse right ventricle (RV) remodelling, assessed as reduction/modification of the end diastolic and end systolic RV diameters.	1, 2 and 3 years
Secondary	Pulmonary Artery Pressure (PAP)	To compare the effect of the 2 strategies for non-severe TR on pulmonary artery pressure (PAP)	1, 2 and 3 years
Secondary	Event free survival	Safety evaluation will rely on all AE/SAEs subsequent to spontaneous reporting, or to detection of clinically relevant abnormalities on physical examinations, vital signs, ECG, and laboratory tests	3 years