Clinical trial NCT01301625: MitraClip System in Australia and New Zealand
Official title: A Prospective Single Arm Clinical Trial Evaluating the MitraClip System in Australia and New Zealand
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Mitral Regurgitation
Keywords: MitraClip
mitral regurgitation (MR)
mitral valve insufficiency
percutaneous mitral valve repair
congestive heart failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Abbott
First posted: 2011-02-23
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients eligible to receive the MitraClip implant at the designated investigational sites in Australia and New Zealand.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)
timeFrame: Baseline
measure: Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)
timeFrame: 30 days
measure: Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)
timeFrame: 6 months
measure: Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants With 0, 1, 2, and 3 MitraClip Devices Implanted
timeFrame: Day 0 (On the day of procedure)
measure: Number of Participants With Acute Procedural Success Rate
timeFrame: At day 0 (on the day of index procedure)
measure: Procedure Time
timeFrame: At day 0 (on the day of index procedure)
measure: Device Time
timeFrame: At day 0 (on the day of index procedure)
measure: Fluoroscopy Duration
timeFrame: At day 0 (on the day of index procedure)
measure: Total Contrast Volume
timeFrame: At day 0 (on the day of index procedure)
measure: Left Ventricle End Diastolic Volume (LVEDV)
timeFrame: At Baseline and Discharge (≤7 days of index procedure)
measure: Left Ventricle End Diastolic Volume (LVEDV)
timeFrame: At Baseline and 30 Days
measure: Left Ventricle End Diastolic Volume (LVEDV)
timeFrame: At Baseline and 12 months
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: At Baseline and Discharge (≤7 days of index procedure)
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: At Baseline and 30 Days
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: At Baseline and 12 months
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: At Baseline and Discharge (≤7 days of index procedure)
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: At Baseline and 30 Days
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: At Baseline and 12 months
measure: Number of Participants With MR Severity
timeFrame: Baseline
measure: Number of Participants With MR Severity
timeFrame: At discharge (≤7 days of index procedure)
measure: Number of Participants With MR Severity
timeFrame: 30 days
measure: Number of Participants With MR Severity
timeFrame: 6 months
measure: Number of Participants With MR Severity
timeFrame: 12 months
measure: Left Ventricular Internal Diameter End Diastole (LVIDd)
timeFrame: At Baseline and Discharge (≤7 days of index procedure)
measure: Left Ventricular Internal Diameter End Diastole (LVIDd)
timeFrame: At Baseline and 30 Days
measure: Left Ventricular Internal Diameter End Diastole (LVIDd)
timeFrame: At Baseline and 12 Months
measure: Left Ventricular Internal Diameter End Systole (LVIDs)
timeFrame: At Baseline and Discharge (≤7 days of index procedure)
measure: Left Ventricular Internal Diameter End Systole (LVIDs)
timeFrame: At Baseline and 30 Days
measure: Left Ventricular Internal Diameter End Systole (LVIDs)
timeFrame: At Baseline and 12 Months
measure: Regurgitant Volume
timeFrame: At Baseline and Discharge (≤7 days of index procedure)
measure: Regurgitant Volume
timeFrame: At Baseline and 30 Days
measure: Regurgitant Volume
timeFrame: At Baseline and 12 Months
measure: Regurgitant Fraction
timeFrame: At Baseline and Discharge (≤7 days of index procedure)
measure: Regurgitant Fraction
timeFrame: At Baseline and 30 Days
measure: Regurgitant Fraction
timeFrame: At Baseline and 12 Months
measure: Mitral Valve Area (MVA) by Pressure Half-time (PHT)
timeFrame: At Baseline and Discharge (≤7 days of index procedure)
measure: Mitral Valve Area (MVA) by Pressure Half-time (PHT)
timeFrame: At Baseline and 30 Days
measure: Mitral Valve Area (MVA) by Pressure Half-time (PHT)
timeFrame: At Baseline and 12 Months
measure: Mitral Valve Mean Gradient
timeFrame: At Baseline and Discharge (≤7 days of index procedure)
measure: Mitral Valve Mean Gradient
timeFrame: At Baseline and 30 Days
measure: Mitral Valve Mean Gradient
timeFrame: At Baseline and 12 Months
measure: Left Atrial Volume
timeFrame: At Baseline and Discharge (≤7 days of index procedure)
measure: Left Atrial Volume
timeFrame: At Baseline and 30 Days
measure: Left Atrial Volume
timeFrame: At Baseline and 12 Months
measure: Six Minute Walking Distance
timeFrame: Baseline
measure: Six Minute Walking Distance
timeFrame: 30 days
measure: Six Minute Walking Distance
timeFrame: 6 months
measure: Six Minute Walking Distance
timeFrame: 12 months
measure: Percentage of Participants With New York Heart Association (NYHA) Class
timeFrame: Baseline
measure: Percentage of Participants With New York Heart Association (NYHA) Class
timeFrame: 30 days
measure: Percentage of Participants With New York Heart Association (NYHA) Class
timeFrame: 6 months
measure: Percentage of Participants With New York Heart Association (NYHA) Class
timeFrame: 12 months
measure: Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 30 Days
timeFrame: 30 days
measure: Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 6 Months
timeFrame: 6 months
measure: Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 12 Months
timeFrame: 12 months
measure: Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)
timeFrame: Baseline
measure: Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)
timeFrame: 30 days
measure: Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)
timeFrame: 6 months
measure: Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)
timeFrame: 12 months
measure: Number of Participants With Mitral Valve Surgery
timeFrame: 30 days of Post-MitraClip Procedure
measure: Number of Participants With Second Intervention to Place an Additional MitraClip Device
timeFrame: Through 12 months
measure: Rate of Patients Rehospitalized
timeFrame: 30 days
measure: Duration of Rehospitalization
timeFrame: 30 days
measure: Number of Participants at Discharge Facility
timeFrame: < or = 12 days
measure: Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration
timeFrame: Post index procedure within 30 days
measure: Post-procedure Hospital Stay
timeFrame: Post index procedure within 30 days
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital Sydney
state: New South Wales
city: North Ryde
country: Australia
facility: Macquarie University Hosptial
state: New South Wales
city: St Leonards
country: Australia
facility: North Shore Private Hospital
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
Study officials:
affiliation: St Vincent's Hospital - Sydney, Australia
name: David Muller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sir Charles Gairdner Hospital, Perth, Australia
name: Jurgen Passage, FRACs
role: PRINCIPAL_INVESTIGATOR
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