The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices
Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT03502811
Collaborator
Abbott (Industry)
1,041
57
32.2
18.3
0.6
Study Details
Study Description
Brief Summary
The MitraClip EXPAND Study (A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices) is designed to confirm the safety and performance of the MitraClip NTR System and MitraClip XTR System.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The data collected in this study will be used to evaluate device outcomes and characterize trends in patient selection for MitraClip therapy in contemporary real-world use. Moreover, the data will be assessed to identify patient or mitral valve anatomical characteristics that may be most appropriate for these next generation devices.
The MitraClip EXPAND Study will be conducted on commercial MitraClip NTR System and MitraClip XTR System that have received CE Mark and/or FDA approval as required.
Up to 1,000 subjects at a maximum of 60 sites in Europe and the US were initially planned to enroll in the MitraClip EXPAND Study.
Study Design
Study Type:
Observational
Actual Enrollment
:
1041 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip® Devices (EXPAND)
Actual Study Start Date
:
Apr 26, 2018
Actual Primary Completion Date
:
Apr 5, 2019
Actual Study Completion Date
:
Dec 31, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| MitraClip NTR/XTR System Percutaneous mitral valve repair using the MitraClip NTR and XTR system |
Device: MitraClip NTR/XTR System
Percutaneous mitral valve repair using the MitraClip NTR/XTR system.
|
Outcome Measures
Primary Outcome Measures
- Safety Measure: Number of Participants With Major Adverse Events (MAE) [At 30 Days]
MAE was defined as a composite of all-cause Death, Myocardial Infarction, Stroke, or non-elective Cardiovascular (CV) surgery for device related complications (CEC adjudicated).
- Performance Measure: Number of Participants With Mitral Regurgitation (MR) Reduction to ≤2+ [At 30 days]
The performance was measured by Mitral Regurgitation (MR) Reduction to ≤2+ at 30-day visits.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subjects who give consent for their participation
-
Subjects scheduled to receive the MitraClip per the current approved indications for use
-
Subjects with Symptomatic MR (≥3+)
Exclusion Criteria:
- Subjects participating in another clinical study that may impact the follow-up or results of this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baptist Medical Center Princeton | Birmingham | Alabama | United States | 35211 |
| 2 | Phoenix Cardiovascular Research Group | Phoenix | Arizona | United States | 85001 |
| 3 | Scripps Health | La Jolla | California | United States | 92037 |
| 4 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 5 | University of California - Davis Medical Center | Sacramento | California | United States | 95817 |
| 6 | University of Colorado Hospital | Aurora | Colorado | United States | 80309 |
| 7 | JFK Medical Center | West Palm Beach | Florida | United States | 33401 |
| 8 | Northwestern Memorial Hospital | Chicago | Illinois | United States | 60007 |
| 9 | Via Christi Regional Medical Center - St. Francis Campus | Kansas City | Kansas | United States | 67218 |
| 10 | Abbott Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
| 11 | St. Luke's Hospital | Kansas City | Missouri | United States | 64102 |
| 12 | Atlantic Health System - Morristown Memorial Hospital | Morristown | New Jersey | United States | 07960 |
| 13 | New York-Presbyterian/Columbia University Medical Center | New York | New York | United States | 10001 |
| 14 | Mount Sinai Hospital | New York | New York | United States | 10011 |
| 15 | New York University Hospital | New York | New York | United States | 10016 |
| 16 | Carolinas Medical Center | Charlotte | North Carolina | United States | 28203 |
| 17 | Christ Hospital | Cincinnati | Ohio | United States | 41073 |
| 18 | St. Thomas Hospital | Nashville | Tennessee | United States | 37236 |
| 19 | Intermountain Medical Center | Murray | Utah | United States | 84107 |
| 20 | University of Virginia Medical Center | Charlottesville | Virginia | United States | 22903 |
| 21 | Sentara Norfolk General Hospital | Norfolk | Virginia | United States | 23504 |
| 22 | University of Washington Medical Center | Seattle | Washington | United States | 98101 |
| 23 | München Grosshadern | München | Bavaria | Germany | 81377 |
| 24 | UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universitat Mainz | Mainz | Rhinela | Germany | 55131 |
| 25 | Herzzentrum Leipzig GmbH | Leipzig | Saxony | Germany | 04289 |
| 26 | Kerckhoff-Klinik gGmbH | Bad Nauheim | Germany | ||
| 27 | Deutsches Herzzentrum Berlin | Berlin | Germany | ||
| 28 | Immanuelklinikum Bernau und Herzzentrum Brandenburg | Bernau | Germany | ||
| 29 | St.-Johannes-Hospital | Dortmund | Germany | ||
| 30 | Medizinische Einrichtungen der Universität Düsseldorf | Düsseldorf | Germany | ||
| 31 | Klinikum der Justus-Liebig-Universität | Gießen | Germany | ||
| 32 | Universitatsmedizin Gottingen Georg-August-Universitat | Göttingen | Germany | ||
| 33 | Katholisches Marienkrankenhaus GmbH | Hamburg | Germany | 22087 | |
| 34 | Klinikum der Ruprecht-Karls-Universität Heidelberg | Heidelberg | Germany | ||
| 35 | Klinikum Karlsburg der Klinikgruppe Dr. Guth GmbH & Co. KG. | Karlsburg | Germany | ||
| 36 | Medizinische Einrichtungen der Universitat zu Koln | Köln | Germany | ||
| 37 | Otto-von-Guericke-Universität Magdeburg | Magdeburg | Germany | ||
| 38 | Klinikum Rechts Der Isar der Technischen Universitat Munchen | München | Germany | ||
| 39 | Niels-Stensen-Kliniken Marienhospital Osnabrück | Osnabrück | Germany | ||
| 40 | Universitatsklinikum Ulm | Ulm | Germany | ||
| 41 | Hadassah - Ein Kerem | Jerusalem | Israel | ||
| 42 | Shaare Zedek Medical Center | Jerusalem | Israel | ||
| 43 | Ospedale San Raffaele- Cardiac | Milano | Lombard | Italy | 20132 |
| 44 | Ospedale San Raffaele | Milano | Lombard | Italy | 20132 |
| 45 | Policlinico San Donato | Milano | Lombard | Italy | 20132 |
| 46 | Presidio Ospedaliero Ferrarotto Alessi | Catania | Sicilia | Italy | 95124 |
| 47 | Centro Cardiologico Monzino | Milan | Italy | ||
| 48 | Catharina Ziekenhuis | Eindhoven | Netherlands | ||
| 49 | St. Antonius Ziekenhuis | Nieuwegein | Netherlands | ||
| 50 | UMC Utrecht | Utrecht | Netherlands | ||
| 51 | Hospital de la Santa Creu I Sant Pau | Barcelona | Spain | ||
| 52 | Hospital Puerta de Hierro - Hospital Universitario | Madrid | Spain | ||
| 53 | HCU Virgen de la Victoria | Málaga | Spain | ||
| 54 | Kantonsspital | Aarau | Switzerland | ||
| 55 | Inselspital - University Hospital of Bern | Bern | Switzerland | 3010 | |
| 56 | Universitaets Spital Zuerich | Zürich | Switzerland | 8091 | |
| 57 | Royal Brompton Hospital | London | United Kingdom |
Sponsors and Collaborators
- Abbott Medical Devices
- Abbott
Investigators
- Principal Investigator: Dr. Saibal Kar, MD, Cedars Sinai, Los Angeles CA
- Principal Investigator: Prof. Francesco Maisano, MD, University Hospital, Zürich
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT03502811
Other Study ID Numbers:
- 17-518
First Posted:
Apr 19, 2018
Last Update Posted:
Feb 16, 2022
Last Verified:
Dec 1, 2021
Keywords provided by Abbott Medical Devices
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | A total of 1041 subjects attempted MitraClip procedure as of the cut-off date of August 5, 2020. |
|---|---|
| Pre-assignment Detail | A total of 1045 subjects were screened between April 5, 2018 and March 29, 2019, of which 4 subjects did not have any procedure attempted. |
| Arm/Group Title | MitraClip NTR/XTR System |
|---|---|
| Arm/Group Description | Percutaneous mitral valve repair using the MitraClip NTR and XTR system |
| Period Title: Overall Study | |
| STARTED | 1041 |
| COMPLETED | 722 |
| NOT COMPLETED | 319 |
Baseline Characteristics
| Arm/Group Title | MitraClip NTR/XTR System |
|---|---|
| Arm/Group Description | Percutaneous mitral valve repair using the MitraClip NTR and XTR system |
| Overall Participants | 1041 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
77.3
(9.7)
|
| Sex/Gender, Customized (Count of Participants) | |
| Male |
571
54.9%
|
| Female |
470
45.1%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Region of Enrollment (Count of Participants) | |
| United States |
420
40.3%
|
| Germany |
384
36.9%
|
| Israel |
19
1.8%
|
| United Kingdom |
3
0.3%
|
| Spain |
25
2.4%
|
| Netherlands |
31
3%
|
| Switzerland |
39
3.7%
|
| Italy |
120
11.5%
|
| Cardiac Intervention History: Prior Cardiac Surgeries (Count of Participants) | |
| Count of Participants [Participants] |
294
28.2%
|
Outcome Measures
| Title | Safety Measure: Number of Participants With Major Adverse Events (MAE) |
|---|---|
| Description | MAE was defined as a composite of all-cause Death, Myocardial Infarction, Stroke, or non-elective Cardiovascular (CV) surgery for device related complications (CEC adjudicated). |
| Time Frame | At 30 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed includes subjects who were available at that time of analysis |
| Arm/Group Title | MitraClip NTR/XTR System |
|---|---|
| Arm/Group Description | Percutaneous mitral valve repair using the MitraClip NTR and XTR system |
| Measure Participants | 1036 |
| All-cause Death (Cardiovascular Death) |
24
2.3%
|
| Myocardial Infarction |
0
0%
|
| Stroke |
8
0.8%
|
| Non-elective CV surgeries for device-related complications |
11
1.1%
|
| Title | Performance Measure: Number of Participants With Mitral Regurgitation (MR) Reduction to ≤2+ |
|---|---|
| Description | The performance was measured by Mitral Regurgitation (MR) Reduction to ≤2+ at 30-day visits. |
| Time Frame | At 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed includes subjects who were available at that time of analysis |
| Arm/Group Title | MitraClip NTR/XTR System |
|---|---|
| Arm/Group Description | Percutaneous mitral valve repair using the MitraClip NTR and XTR system |
| Measure Participants | 864 |
| Count of Participants [Participants] |
845
81.2%
|
Adverse Events
| Time Frame | 1 year | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | MitraClip NTR/XTR System | |
| Arm/Group Description | Percutaneous mitral valve repair using the MitraClip NTR and XTR system | |
All Cause Mortality |
||
| MitraClip NTR/XTR System | ||
| Affected / at Risk (%) | # Events | |
| Total | 157/1041 (15.1%) | |
Serious Adverse Events |
||
| MitraClip NTR/XTR System | ||
| Affected / at Risk (%) | # Events | |
| Total | 392/1041 (37.7%) | |
| Blood and lymphatic system disorders | ||
| ANAEMIAS NONHAEMOLYTIC AND MARROW DEPRESSION | 6/1041 (0.6%) | 6 |
| HAEMOLYSES AND RELATED CONDITIONS | 1/1041 (0.1%) | 1 |
| Cardiac disorders | ||
| CARDIAC ARRHYTHMIAS | 54/1041 (5.2%) | 56 |
| CARDIAC DISORDER SIGNS AND SYMPTOMS | 1/1041 (0.1%) | 1 |
| CARDIAC VALVE DISORDERS | 32/1041 (3.1%) | 32 |
| CORONARY ARTERY DISORDERS | 23/1041 (2.2%) | 26 |
| HEART FAILURES | 181/1041 (17.4%) | 250 |
| MYOCARDIAL DISORDERS | 3/1041 (0.3%) | 3 |
| PERICARDIAL DISORDERS | 4/1041 (0.4%) | 4 |
| Congenital, familial and genetic disorders | ||
| CARDIAC AND VASCULAR DISORDERS CONGENITAL | 3/1041 (0.3%) | 3 |
| Gastrointestinal disorders | ||
| GASTROINTESTINAL HAEMORRHAGES NEC | 2/1041 (0.2%) | 2 |
| GASTROINTESTINAL SIGNS AND SYMPTOMS | 1/1041 (0.1%) | 1 |
| GASTROINTESTINAL STENOSIS AND OBSTRUCTION | 1/1041 (0.1%) | 1 |
| General disorders | ||
| GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS COMPLICATIONS ASSOCIATED WITH DEVICE | 1/1041 (0.1%) | 1 |
| DEVICE ISSUES | 4/1041 (0.4%) | 4 |
| FATAL OUTCOMES | 32/1041 (3.1%) | 32 |
| GENERAL SYSTEM DISORDERS NEC | 6/1041 (0.6%) | 10 |
| Hepatobiliary disorders | ||
| HEPATIC AND HEPATOBILIARY DISORDERS | 1/1041 (0.1%) | 1 |
| Infections and infestations | ||
| INFECTIONS - PATHOGEN UNSPECIFIED | 19/1041 (1.8%) | 20 |
| Injury, poisoning and procedural complications | ||
| INJURIES NEC | 5/1041 (0.5%) | 5 |
| PROCEDURAL RELATED INJURIES AND COMPLICATIONS NEC | 6/1041 (0.6%) | 6 |
| Investigations | ||
| CARDIAC AND VASCULAR INVESTIGATIONS | 1/1041 (0.1%) | 1 |
| HAEMATOLOGY INVESTIGATIONS | 1/1041 (0.1%) | 1 |
| Metabolism and nutrition disorders | ||
| ELECTROLYTE AND FLUID BALANCE CONDITIONS | 1/1041 (0.1%) | 1 |
| RESPIRATORY AND MEDIASTINAL NEOPLASMS MALIGNANT AND UNSPECIFIED | 2/1041 (0.2%) | 2 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| GASTROINTESTINAL NEOPLASMS MALIGNANT AND UNSPECIFIED | 1/1041 (0.1%) | 1 |
| LEUKAEMIAS | 2/1041 (0.2%) | 2 |
| LYMPHOMAS NON-HODGKIN'S B-CELL | 1/1041 (0.1%) | 1 |
| MISCELLANEOUS AND SITE UNSPECIFIED NEOPLASMS MALIGNANT AND UNSPECIFIED | 1/1041 (0.1%) | 1 |
| REPRODUCTIVE NEOPLASMS MALE MALIGNANT AND UNSPECIFIED | 1/1041 (0.1%) | 1 |
| Nervous system disorders | ||
| CENTRAL NERVOUS SYSTEM VASCULAR DISORDERS | 23/1041 (2.2%) | 25 |
| ENCEPHALOPATHIES | 1/1041 (0.1%) | 1 |
| MENTAL IMPAIRMENT DISORDERS | 1/1041 (0.1%) | 1 |
| NEUROLOGICAL DISORDERS NEC | 5/1041 (0.5%) | 5 |
| Renal and urinary disorders | ||
| NEPHROPATHIES | 1/1041 (0.1%) | 1 |
| RENAL DISORDERS | 8/1041 (0.8%) | 8 |
| URINARY TRACT SIGNS AND SYMPTOMS | 2/1041 (0.2%) | 2 |
| Respiratory, thoracic and mediastinal disorders | ||
| BRONCHIAL DISORDERS | 2/1041 (0.2%) | 2 |
| LOWER RESPIRATORY TRACT DISORDERS | 4/1041 (0.4%) | 4 |
| PLEURAL DISORDERS | 3/1041 (0.3%) | 4 |
| PULMONARY VASCULAR DISORDERS | 1/1041 (0.1%) | 1 |
| RESPIRATORY DISORDERS NEC | 18/1041 (1.7%) | 18 |
| Surgical and medical procedures | ||
| CARDIAC THERAPEUTIC PROCEDURES | 2/1041 (0.2%) | 2 |
| SOFT TISSUE THERAPEUTIC PROCEDURES | 1/1041 (0.1%) | 1 |
| Vascular disorders | ||
| ANEURYSMS AND ARTERY DISSECTIONS | 2/1041 (0.2%) | 2 |
| ARTERIOSCLEROSIS, STENOSIS, VASCULAR INSUFFICIENCY AND NECROSIS | 4/1041 (0.4%) | 4 |
| DECREASED AND NONSPECIFIC BLOOD PRESSURE DISORDERS AND SHOCK | 12/1041 (1.2%) | 13 |
| EMBOLISM AND THROMBOSIS | 2/1041 (0.2%) | 2 |
| VASCULAR DISORDERS NEC | 2/1041 (0.2%) | 2 |
| VASCULAR HAEMORRHAGIC DISORDERS | 37/1041 (3.6%) | 38 |
| VASCULAR HYPERTENSIVE DISORDERS | 2/1041 (0.2%) | 2 |
| VASCULAR INJURIES | 1/1041 (0.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| MitraClip NTR/XTR System | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/1041 (0%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Nadia Bouhdi |
|---|---|
| Organization | Abbott |
| Phone | 32-479-94-10-37 |
| nadia.bouhdi@abbott.com |
Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT03502811
Other Study ID Numbers:
- 17-518
First Posted:
Apr 19, 2018
Last Update Posted:
Feb 16, 2022
Last Verified:
Dec 1, 2021