MitraClip System in Australia and New Zealand

Terminated

Conditions: Mitral Regurgitation

Interventions: Device: MitraClip Implant

Registration Number: NCT01301625

Lead Sponsor: Abbott Medical Devices

Brief Summary: The primary objective of the MitraClip System Australia and New Zealand (ANZ) Clinical Trial is to gather real-world clinical and health-economic outcome data to support the long-term safety, efficacy and economic value of the MitraClip System in the continuum of therapies for treating MR. Specifically, the following clinical and economic data will be collected: New York Heart Association (NYHA) Functional Class, Six-Minute Walk Test (6MWT) distance, quality of life (QOL) information, echocardiographic measures of left ventricular size and function, and data associated with the index hospitalization, rehospitalizations, concomitant medications and discharge facility to support the MitraClip System economic analysis.

Detailed Description: The MitraClip System ANZ Clinical Trial is a prospective, observational, single arm, multicenter trial to evaluate the MitraClip device for the treatment of mitral regurgitation (MR). Patients will be enrolled at up to 15 investigational sites throughout Australia and New Zealand. Up to 150 patients will be enrolled. Patients will be considered enrolled when local or general anesthesia is administered for the MitraClip procedure. Patients will be followed at discharge, 30 days, 6 months, 12 months and 24 months.

Investigational sites will recruit consecutive patients who meet trial enrollment criteria. Until enrollment in the MitraClip System ANZ Clinical Trial is closed, all patients who undergo a procedure for placement of a MitraClip device at an investigational site should be enrolled in the MitraClip System ANZ Clinical Trial.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 78

Inclusion Criteria

Age 18 years or older.
MR ≥ 3+ .
Transseptal catheterization and femoral vein access feasible.
Placement of the MitraClip device on mitral leaflets feasible.
Mitral valve orifice area ≥ 4.0 cm2.
Written informed consent obtained.
The patient agrees to return for follow-up visits.

Exclusion Criteria

Need for emergency surgery, other cardiac surgery.
Coronary artery disease (CAD), atrial fibrillation (AF), other valve disease.
Prior mitral valve repair surgery, mechanical prosthetic valve, or ventricular assist device (VAD).
Active endocarditis or rheumatic heart disease; leaflets degenerated from endocarditis or rheumatic disease.
Transesophageal echocardiography (TEE) contraindicated.
Known hypersensitivity or contraindication to trial or procedure medications which cannot be managed medically.
Currently participating in investigational drug trial or another device trial that has not yet completed the primary endpoint or that interferes with the MitraClip System ANZ Clinical Trial.
Pregnant or planning pregnancy within next 12 months.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MitraClip Implant	MitraClip Implant	Eligible patients undergoing a MitraClip procedure in Australia and New Zealand

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)	12 months	Clinical Endpoint. * Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) * Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Secondary Outcome Measures

Name	Time	Method
Left Ventricle End Diastolic Volume (LVEDV)	At Baseline and 12 months	Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular End Systolic Volume (LVESV)	At Baseline and 12 months	Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.
Left Ventricular Ejection Fraction (LVEF)	At Baseline and 12 months	Left ventricular ejection fraction is assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks).
Number of Participants With MR Severity	12 months	Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography. MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe.
Number of Participants With 0, 1, 2, and 3 MitraClip Devices Implanted	Day 0 (On the day of procedure)	This is one of the Device and Procedure-Related Endpoints. Implant Rate is defined as the rate of successful delivery and deployment of MitraClip device implant(s) with echocardiographic evidence of leaflet approximation and retrieval of the delivery catheter.
Number of Participants With Acute Procedural Success Rate	At day 0 (on the day of index procedure)	Defined as successful MitraClip implantation with resulting MR of 2+ or less.
Total Contrast Volume	At day 0 (on the day of index procedure)	This is one of the Device and Procedure-Related Endpoints.
Left Ventricular Internal Diameter End Systole (LVIDs)	At Baseline and 12 Months	LVIDs is the measurements of the left ventricular internal dimension at end-systole and normally corresponds to the smallest cardiac dimension. LVIDs is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory.
Regurgitant Volume	At Baseline and 12 Months	Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Number of Participants at Discharge Facility	< or = 12 days	This is the economic data reported to support the MitraClip System economic analysis.
Device Time	At day 0 (on the day of index procedure)	This is one of the Device and Procedure-Related Endpoints. Device Time is defined as the time the Steerable Guide Catheter is placed in the intra-atrial septum until the time the MitraClip Delivery System (CDS) is retracted into the Steerable Guide Catheter. Device Time is shorter in duration than Procedure Time because it does not include the time required to perform transseptal access into the left atrium.
Fluoroscopy Duration	At day 0 (on the day of index procedure)	This is one of the Device and Procedure-Related Endpoints. Mean fluoroscopy duration during the MitraClip procedure.
Left Ventricular Internal Diameter End Diastole (LVIDd)	At Baseline and 12 Months	LVIDd is the measurements of the left ventricular internal dimension at end-diastole and normally corresponds to the largest cardiac dimension. LVIDd is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory.
Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)	12 months	Death: Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories: A. Cardiac death is defined as death due to any of the following: * Acute myocardial infarction * Cardiac perforation/pericardial tamponade * Arrhythmia or conduction abnormality * Stroke within 30 days of the procedure or stroke suspected of being related to the procedure * Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery * Any death for which a cardiac cause cannot be excluded. B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above). Congestive Heart Failure (CHF): Defined as a documented diagnosis of CHF on the hospital admission report or discharge summary.
Number of Participants With Second Intervention to Place an Additional MitraClip Device	Through 12 months	Second MitraClip device interventions are reported by Abbott Vascular personnel on Procedural Observation Forms. A second MitraClip device intervention is a good option for patients with MR following placement of the original MitraClip device.
Duration of Rehospitalization	30 days
Post-procedure Hospital Stay	Post index procedure within 30 days	This is the Economic data reported to support the MitraClip System economic analysis. It is defined as the mean duration of time that patients spent in hospital following the MitraClip procedure.
Procedure Time	At day 0 (on the day of index procedure)	This is one of the Device and Procedure-Related Endpoints. Procedure Time is defined as the time elapsed from the start of the transseptal procedure to the time the Steerable Guide Catheter is removed.
Mitral Valve Area (MVA) by Pressure Half-time (PHT)	At Baseline and 12 Months	Measure of the area of the mitral valve orifice using transthoracic echocardiography. The pressure half time method is used to assess the presence and severity of mitral stenosis. Results are interpreted by the study's echocardiography core laboratory.
Mitral Valve Mean Gradient	At Baseline and 12 Months	Mitral valve mean gradient is defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Six Minute Walking Distance	12 months	The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. It is a measure of a patient's exercise capacity.
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 12 Months	12 months	The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower\&higher MLHFQ score indicates less effect of heart failure\&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL. The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)\&c) other factors,measured using 8 questions (possible subscale score from 0-40).
Regurgitant Fraction	At Baseline and 12 Months	Regurgitant fraction as determined by the core echo laboratory. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.
Percentage of Participants With New York Heart Association (NYHA) Class	12 months	* Class I Patients with cardiac disease but without resulting limitations of physical activity; * Class II Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain; * Class III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain; * Class IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 6 Months	6 months	The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower\&higher MLHFQ score indicates less effect of heart failure\&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL. The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)\&c) other factors,measured using 8 questions (possible subscale score from 0-40).
Number of Participants With Mitral Valve Surgery	30 days of Post-MitraClip Procedure	Mital Valve Surgery Post-MitraClip Procedure; Surgery Types includes Replacement and Repair.
Rate of Patients Rehospitalized	30 days	Defined as re-admission of patients to the hospital following discharge from the Clip procedure.
Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration	Post index procedure within 30 days	ICU and hospital stay is defined as the mean duration of time that patients spent in the ICU (Intensive Care Unit)/ CCU (Cardiac Care Unit)/ PACU (Post-Anesthesia Care Unit) following the MitraClip procedure.
Left Atrial Volume	At Baseline and 12 Months	Left atrial volume is assessed by echocardiography. Using the single plane method of disks, the left atrial volume is derived by planimetry in the 4-chamber view at end-systole.
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 30 Days	30 days	The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower\&higher MLHFQ score indicates less effect of heart failure\&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL. The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)\&c) other factors,measured using 8 questions (possible subscale score from 0-40).

Trial Locations

Locations (6): Flinders Medical Centre
🇦🇺
Bedford Park, South Australia, Australia
The Prince Charles Hospital
🇦🇺
Chermside, Queensland, Australia
St. Vincent's Hospital Sydney
🇦🇺
Darlinghurst, New South Wales, Australia
Macquarie University Hosptial
🇦🇺
North Ryde, New South Wales, Australia
North Shore Private Hospital
🇦🇺
St Leonards, New South Wales, Australia
Sir Charles Gairdner Hospital
🇦🇺
Nedlands, Western Australia, Australia