REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System

• Sponsor: Edwards Lifesciences (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02703311
• Collaborator: (none)
• Enrollment: 11
• Locations: 10
• Arm: 1
• Actual Duration (Months): 28
• Patients Per Site: 1.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The Cardioband Transcatheter System (Cardioband) is indicated for the treatment of secondary (functional) mitral regurgitation (FMR). The Cardioband is a transcatheter system, deployed on the beating heart through a transseptal approach. The Cardioband is deployed along the posterior annulus of the mitral valve (MV) and is adjusted under trans-esophageal guidance on the beating heart. A CE mark study with 30 subjects has been completed and documented reduction of severity of mitral regurgitation (MR) and improvement in 6- minute walk test in subjects with moderate to severe MR.

Study objectives are to test the efficacy of the Cardioband in improving MR and heart failure symptoms in patients with symptomatic (New York Heart Association (NYHA) Class III-IVa), severe MR in the post-marketing setting, And to evaluate the safety of the Cardioband system in the post-marketing setting.

Condition or Disease	Intervention/Treatment	Phase
Mitral Valve Insufficiency; Cardiac Valve Annuloplasty; Mitral Valve Annuloplasty; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Regurgitation	Device: Cardioband	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System
• Actual Study Start Date: Aug 1, 2016
• Actual Primary Completion Date: Nov 1, 2017
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Cardioband procedure Mitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance	Device: Cardioband; Mitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance

Outcome Measures

Primary Outcome Measures

1. Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale. [30 days]

   Percentage of Patients with Reduction in MR Severity of at least one grade at 30 days compared to baseline

Secondary Outcome Measures

1. Change in Distance Walked on 6 Minute Walk Test [6 months over Baseline]

   Median distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months compared to baseline

2. Change in Mitral Regurgitation Severity [6, 12, and 24 months over baseline]

   Mitral Regurgitation at 6, 12, and 24 months compared to baseline

Other Outcome Measures

1. Change in Distance Walked on 6 Minute Walk Test [12, and 24 months over baseline]

   Median distance in meters walked during 6 Minute Walk Test (6MWT) at 12 and 24 months compared to baseline

2. Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [6, 12, and 24 months over baseline]

   Median KCCQ Score. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status.

3. Change in New York Heart Association (NYHA) Class [6, 12, and 24 months over baseline]

   NYHA Class at 6, 12, and 24 months compared to baseline

4. Change in Left Ventricular End Diastolic Volume (LVEDV) [6, 12, and 24 months over baseline]

   Median LVEDV data, as measured by TTE at 6, 12, and 24 months compared to baseline

5. Change in Left Ventricular End Systolic Volume (LVESV) [6, 12, and 24 months over baselines]

   Median LVESV data, as measured by TTE at 6, 12, and 24 months compared to baseline

6. Number of Participants With Device Success [Discharge]

   Device success is defined as deployment of the Cardioband, with MR reduction at hospital discharge.

7. Number of Participants With Patient Success [6 and 12 months]

   Individual patient success (measured at 6 months and 1 year) defined as device success and the following: Discharged from index hospitalization NYHA class improvement by at least 1 level from baseline

8. Number of Days Alive and Out of Hospital [12 months]

   Days alive and out of hospital due to major cardiovascular events at 1 year

9. Freedom From All-cause Mortality and Major Adverse Events (AE) [30 days from implant procedure or hospital discharge, whichever is later.]

   Freedom from all-cause mortality and major AE is defined as disabling stroke, myocardial infarction (MI) (peri-procedural or spontaneous), renal failure requiring dialysis, life-threatening bleeding, cardiac tamponade and device related cardiac surgical intervention at 30 days from the implant procedure or hospital discharge, whichever is later.

10. Need for Urgent/Emergent Surgical Intervention [24 months]

    Number of patients who undergo urgent/emergent surgical intervention post procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age ≥18 years

2. Severe (3+ to 4+) secondary Mitral Regurgitation

3. Symptomatic heart failure (NYHA Class III-IVa) despite guideline directed medical therapy including CRT if indicated

4. The Local Site Heart Team concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy.

5. Transfemoral access and transseptal deployment of the Cardioband is determined to be feasible

6. Subject is willing and able to provide informed consent and follow protocol

Exclusion Criteria:

1. EF < 20%

2. LVEDD ≥ 70 mm

3. Heavily calcified annulus or leaflets

4. Significant CAD requiring revascularization

5. Active bacterial endocarditis

6. Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months

7. Renal insufficiency requiring dialysis

8. Life expectancy of less than twelve months

9. Subject is participating in concomitant research studies of investigational products that have not reached their primary endpoint

10. Pulmonary hypertension ≥ 70mmHg at rest

11. Mitral valve anatomy which may preclude proper device treatment

12. Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and/or severe tricuspid regurgitation

13. Severe liver disease

14. Patient is pregnant or lactating

15. Hypersensitivity to Nickel or Chromium

16. Clinically significant bleeding diathesis or coagulopathy

17. History of mitral valve repair

18. TIA or CVA within 3 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bichat hospital	Paris		France	18 75877
2	Bad Nauheim, Kerckhoff-Klinik	Bad Nauheim		Germany	61231
3	Bonn University	Bonn		Germany
4	Universitätsklinikum Gießen und Marburg	Giessen		Germany
5	University Hospital Halle (Saale)	Halle		Germany
6	Asklepios Klinik, St. Georg	Hamburg		Germany	5 20099
7	Universitäres Herzzentrum Hamburg GmbH	Hamburg		Germany
8	Koln, Universitätsklinikum	Koln		Germany
9	Universitatsmedizin Mainz	Mainz		Germany
10	Hospital san raffaele	Milano		Italy	20132

Sponsors and Collaborators

• Edwards Lifesciences

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 31, 2017

More Information

Publications

None provided.

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT02703311
• Other Study ID Numbers: CB1-3
• First Posted: Mar 9, 2016
• Last Update Posted: Nov 9, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Edwards Lifesciences: Valtech Cardio; Cardioband; Mitral Valve
• Additional relevant MeSH terms: Cardiovascular Diseases; Heart Diseases; Mitral Valve Insufficiency; Heart Valve Diseases

Study Results

Participant Flow

Arm/Group Title	Cardioband
Arm/Group Description	Patients who were enrolled and had the Cardioband procedure attempted
Period Title: Overall Study
STARTED	11
Implanted	11
30 Day Follow-Up Completed	9
COMPLETED	3
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Cardioband
Arm/Group Description	Patients who were enrolled and had the Cardioband procedure attempted
Overall Participants	11
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.9 (9.0)
Sex: Female, Male (Count of Participants)
Female	5 45.5%
Male	6 54.5%
Race and Ethnicity Not Collected (Count of Participants)
EuroScore II (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	7.1 (5.3)
NYHA Functional Class III or IV (Count of Participants)
Count of Participants [Participants]	11 100%
Ischemic Etiology of Regurgitation (Count of Participants)
Count of Participants [Participants]	4 36.4%
Dilated Cardiomyopathy (Count of Participants)
Count of Participants [Participants]	5 45.5%
Previous Coronary Artery Bypass Graft (Count of Participants)
Count of Participants [Participants]	4 36.4%
Chronic Renal Disease (Count of Participants)
Count of Participants [Participants]	8 72.7%
Paroxysmal, Persistent, Chronic Atrial Flutter/Fibrillation (Count of Participants)
Count of Participants [Participants]	10 90.9%

Outcome Measures

1. Primary Outcome

Title	Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale.
Description	Percentage of Patients with Reduction in MR Severity of at least one grade at 30 days compared to baseline
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Intra-subject comparison of patients with paired data at baseline and 30 days

Arm/Group Title	Cardioband
Arm/Group Description	Patients who were enrolled and had the Cardioband procedure attempted
Measure Participants	7
Count of Participants [Participants]	4 36.4%

2. Secondary Outcome

Title	Change in Distance Walked on 6 Minute Walk Test
Description	Median distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months compared to baseline
Time Frame	6 months over Baseline

Outcome Measure Data

Analysis Population Description

Intra-subject comparison of patients with paired data at baseline and 6 months

Arm/Group Title	Cardioband
Arm/Group Description	Patients who were enrolled and had the Cardioband procedure attempted
Measure Participants	6
Median (Standard Deviation) [Meters]	30.7 (60.4)

3. Secondary Outcome

Title	Change in Mitral Regurgitation Severity
Description	Mitral Regurgitation at 6, 12, and 24 months compared to baseline
Time Frame	6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

This planned endpoint of change mitral regurgitation severity in was unable to be analyzed due to the small sample size that was achieved in this study. Data available at each time point were reported as number of patients with MR grades None/Trace, Mild, Moderate, Severe.

Arm/Group Title	Cardioband
Arm/Group Description	Patients who were enrolled and had the Cardioband procedure attempted
Measure Participants	9
None/Trace	0 0%
Mild	2 18.2%
Moderate	4 36.4%
Severe	3 27.3%
None/Trace	1 9.1%
Mild	3 27.3%
Moderate	1 9.1%
Severe	0 0%
None/Trace	0 0%
Mild	3 27.3%
Moderate	0 0%
Severe	0 0%
None/Trace
Mild
Moderate
Severe

4. Other Pre-specified Outcome

Title	Change in Distance Walked on 6 Minute Walk Test
Description	Median distance in meters walked during 6 Minute Walk Test (6MWT) at 12 and 24 months compared to baseline
Time Frame	12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study

Arm/Group Title	Cardioband
Arm/Group Description	Patients who were enrolled and had the Cardioband procedure attempted
Measure Participants	0

5. Other Pre-specified Outcome

Title	Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description	Median KCCQ Score. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status.
Time Frame	6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study

Arm/Group Title	Cardioband
Arm/Group Description	Patients who were enrolled and had the Cardioband procedure attempted
Measure Participants	0

6. Other Pre-specified Outcome

Title	Change in New York Heart Association (NYHA) Class
Description	NYHA Class at 6, 12, and 24 months compared to baseline
Time Frame	6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study

Arm/Group Title	Cardioband
Arm/Group Description	Patients who were enrolled and had the Cardioband procedure attempted
Measure Participants	0

7. Other Pre-specified Outcome

Title	Change in Left Ventricular End Diastolic Volume (LVEDV)
Description	Median LVEDV data, as measured by TTE at 6, 12, and 24 months compared to baseline
Time Frame	6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study

Arm/Group Title	Cardioband
Arm/Group Description	Patients who were enrolled and had the Cardioband procedure attempted
Measure Participants	0

8. Other Pre-specified Outcome

Title	Change in Left Ventricular End Systolic Volume (LVESV)
Description	Median LVESV data, as measured by TTE at 6, 12, and 24 months compared to baseline
Time Frame	6, 12, and 24 months over baselines

Outcome Measure Data

Analysis Population Description

This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study

Arm/Group Title	Cardioband
Arm/Group Description	Patients who were enrolled and had the Cardioband procedure attempted
Measure Participants	0

9. Other Pre-specified Outcome

Title	Number of Participants With Device Success
Description	Device success is defined as deployment of the Cardioband, with MR reduction at hospital discharge.
Time Frame	Discharge

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Subjects with missing data are excluded from the analysis.

Arm/Group Title	Cardioband
Arm/Group Description	Patients who were enrolled and had the Cardioband procedure attempted
Measure Participants	8
Count of Participants [Participants]	7 63.6%

10. Other Pre-specified Outcome

Title	Number of Participants With Patient Success
Description	Individual patient success (measured at 6 months and 1 year) defined as device success and the following: Discharged from index hospitalization NYHA class improvement by at least 1 level from baseline
Time Frame	6 and 12 months

Outcome Measure Data

Analysis Population Description

The outcome is reported for subjects where data is available. Subjects with missing data are excluded from the analysis.

Arm/Group Title	Cardioband
Arm/Group Description	Patients who were enrolled and had the Cardioband procedure attempted
Measure Participants	5
6 Months	3 27.3%
12 Months	3 27.3%

11. Other Pre-specified Outcome

Title	Number of Days Alive and Out of Hospital
Description	Days alive and out of hospital due to major cardiovascular events at 1 year
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

This planned endpoint was unable to be analyzed due to the small sample size that was achieved in this study

Arm/Group Title	Cardioband
Arm/Group Description	Patients who were enrolled and had the Cardioband procedure attempted
Measure Participants	0

12. Other Pre-specified Outcome

Title	Freedom From All-cause Mortality and Major Adverse Events (AE)
Description	Freedom from all-cause mortality and major AE is defined as disabling stroke, myocardial infarction (MI) (peri-procedural or spontaneous), renal failure requiring dialysis, life-threatening bleeding, cardiac tamponade and device related cardiac surgical intervention at 30 days from the implant procedure or hospital discharge, whichever is later.
Time Frame	30 days from implant procedure or hospital discharge, whichever is later.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cardioband
Arm/Group Description	Patients who were enrolled and had the Cardioband procedure attempted
Measure Participants	11
Count of Participants [Participants]	10 90.9%

13. Other Pre-specified Outcome

Title	Need for Urgent/Emergent Surgical Intervention
Description	Number of patients who undergo urgent/emergent surgical intervention post procedure
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cardioband
Arm/Group Description	Patients who were enrolled and had the Cardioband procedure attempted
Measure Participants	11
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	2 years
Arm/Group Title	Cardioband
Arm/Group Description	Patients who were enrolled and had the Cardioband procedure attempted
All Cause Mortality
	Cardioband
	Affected / at Risk (%)	# Events
Total	5/11 (45.5%)
Serious Adverse Events
	Cardioband
	Affected / at Risk (%)	# Events
Total	9/11 (81.8%)
Cardiac disorders
Arrhythmia	1/11 (9.1%)	1
Atrial Fibrillation	1/11 (9.1%)	1
Cardiac Failure	6/11 (54.5%)	11
Cardiac Failure Acute	1/11 (9.1%)	1
Ventricular Tachycardia	2/11 (18.2%)	2
Ear and labyrinth disorders
Vertigo	1/11 (9.1%)	1
Gastrointestinal disorders
Enteritis	1/11 (9.1%)	1
Large Intestine Polyp	1/11 (9.1%)	1
Mechanical Ileus	1/11 (9.1%)	1
General disorders
General Physical Health Deterioration	1/11 (9.1%)	1
Infections and infestations
Bacterial Infection	1/11 (9.1%)	1
Dermohypodermitis	1/11 (9.1%)	1
Gastroenteritis	1/11 (9.1%)	1
Pneumonia	2/11 (18.2%)	2
Metabolism and nutrition disorders
Metabolic Disorder	1/11 (9.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia	1/11 (9.1%)	1
Nervous system disorders
IIIrd Nerve Disorder	1/11 (9.1%)	1
Product Issues
Device Malfunction	1/11 (9.1%)	1
Psychiatric disorders
Completed Suicide	1/11 (9.1%)	1
Renal and urinary disorders
Haemorrhage Urinary Tract	1/11 (9.1%)	1
Oliguria	1/11 (9.1%)	1
Renal Failure	1/11 (9.1%)	1
Urinary Retention	1/11 (9.1%)	1
Reproductive system and breast disorders
Cervix Oedema	1/11 (9.1%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/11 (9.1%)	1
Vascular disorders
Circulatory Collapse	1/11 (9.1%)	1
Embolism	1/11 (9.1%)	1
Hypotension	1/11 (9.1%)	1
Other (Not Including Serious) Adverse Events
	Cardioband
	Affected / at Risk (%)	# Events
Total	9/11 (81.8%)
Blood and lymphatic system disorders
Anaemia	1/11 (9.1%)	1
Heparin Induced Thrombocytopenia	1/11 (9.1%)	1
Iron Deficiency Anaemia	1/11 (9.1%)	1
Leukocytosis	1/11 (9.1%)	1
Hypochromic Anaemia	1/11 (9.1%)	1
Cardiac disorders
Atrial Fibrillation	2/11 (18.2%)	2
Supraventricular Tachycardia	1/11 (9.1%)	1
Endocrine disorders
Hyperthyroidism	2/11 (18.2%)	2
Gastrointestinal disorders
Abdominal Pain Upper	1/11 (9.1%)	1
Diarrhoea	2/11 (18.2%)	2
Haemorrhoids	1/11 (9.1%)	1
General disorders
Pyrexia	1/11 (9.1%)	1
Infections and infestations
Nasopharyngitis	1/11 (9.1%)	1
Puncture Site Infection	1/11 (9.1%)	1
Sepsis	1/11 (9.1%)	1
Tooth Infection	1/11 (9.1%)	1
Urinary Tract Infection	4/11 (36.4%)	4
Viral Upper Respiratory Tract Infection	1/11 (9.1%)	1
Injury, poisoning and procedural complications
Contusion	1/11 (9.1%)	1
Fall	2/11 (18.2%)	2
Investigations
Creactive Protein Increased	1/11 (9.1%)	1
Haemoglobin Decreased	2/11 (18.2%)	2
Weight Increased	1/11 (9.1%)	1
Metabolism and nutrition disorders
Gout	1/11 (9.1%)	1
Hypokalaemia	1/11 (9.1%)	1
Musculoskeletal and connective tissue disorders
Joint Swelling	1/11 (9.1%)	1
Musculoskeletal Pain	1/11 (9.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma	1/11 (9.1%)	1
Nervous system disorders
Depressed Level of Conciousness	1/11 (9.1%)	1
Product Issues
Device Pacing Issue	1/11 (9.1%)	1
Psychiatric disorders
Depression	1/11 (9.1%)	1
Renal and urinary disorders
Renal Failure	3/11 (27.3%)	3
Respiratory, thoracic and mediastinal disorders
Epistaxis	1/11 (9.1%)	1
Obstructive Airways Disorder	1/11 (9.1%)	1
Pleural Effusion	3/11 (27.3%)	3
Skin and subcutaneous tissue disorders
Pruritus	1/11 (9.1%)	1
Vascular disorders
Hypotension	1/11 (9.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS 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.