Cardioband With Transfemoral Delivery System

• Sponsor: Edwards Lifesciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01841554
• Collaborator: (none)
• Enrollment: 62
• Locations: 11
• Arm: 1
• Actual Duration (Months): 81
• Patients Per Site: 5.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

To evaluate the performance and safety of the Cardioband Adjustable Annuloplasty System for repair of functional mitral regurgitation.

Condition or Disease	Intervention/Treatment	Phase
Mitral Regurgitation	Device: Cardioband	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cardioband Adjustable Annuloplasty System For Transcatheter Repair of Mitral Valve Regurgitation
• Actual Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single	Device: Cardioband; Other Names: With Transfemoral delivery system

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects [30 days]

   Overall rate of Major Serious Adverse Events (SAEs) and serious adverse device effects (SADEs) until hospital discharge and at post-operative 30 days.

Secondary Outcome Measures

1. Performance [6MWT] [Baseline, 6 and 12 months]

   Distance in meters walked during 6 Minute Walk Test (6MWT) at baseline, 6 and 12 months.

2. Performance [MLHFQ] [Baseline, 6 and 12 months]

   Score on Minnesota Living with Heart Failure Questionnaire (MLHFQ). MLHFQ is composed of 21 questions relating to limitations in lifestyle associated with heart failure. Respondents use a 5 point scale from 0 to 5, with a 0 representing no limitation and 5 representing maximum limitation. The total score is computed by adding individual scores of each question. Higher scores are associated with lower quality of life.

3. Performance [Intra-subject Comparison - MR Severity] [Baseline, discharge, 6 and 12 months]

   All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe).

4. Performance [Full Analysis Data Set - MR Severity] [Baseline, discharge, 6 and 12 months]

   All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe).

Other Outcome Measures

1. Reduce MR [Paired Baseline and Follow-Up] [Post-adjustment, discharge, and 30 Days]

   Cardioband ability to reduce mitral valve regurgitation (MR) Intra-procedure, at hospital discharge, and at 30 days. Reported as number of patients showing a reduction in MR grade greater than or equal to 1.

2. Technical Feasibility of Cardioband Adjustment [Immediately after procedure]

   The ability to connect the Adjustment Tool, reduce septo-lateral dimension, and retract the Adjustment Tool with guide wire.

3. Technical Success Rate of the Implantation of the Cardioband [Immediately after implantation]

   The ability to advance the implant, load anchors, anchor the implant to tissue, and retract the Implant Delivery System.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Age > 18 years

• Moderate to severe functional Mitral Regurgitation (MR)

• Symptomatic Patients (NYHA ClassII-IV) despite optimal medical therapy , including Cardiac Resynchronization (CRT) if indicated.

• Left Ventricle Ejection Fraction (LVEF) ≥ 25%, LVEDD ≤ 65mm

• Subject is high risk to undergo Mitral Valve (MV) surgery (as assessed by a surgeon and a cardiologist, at the site)

• Transseptal catheterization and femoral vein access is determined to be feasible

• Subject is able and willing to give informed consent and follow protocol procedures

Exclusion Criteria:

• Active bacterial endocarditis

• Severe organic lesions with retracted chordae or congenital malformations with lack of valvular tissue

• Heavily calcified annulus or leaflets

• Subjects in whom transesophageal echocardiography is contraindicated

• Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization

• CRT implant within 3 months prior to procedure

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

• Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 6 months or severe carotid stenosis (>70% by Ultra sound)

• Renal insufficiency requiring dialysis

• Life expectancy of less than twelve months

• Subject is participating in concomitant research studies of investigational products

• Mitral valve anatomy which may preclude proper device treatment

• Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and severe tricuspid regurgitation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Bichat-Claude Bernard	Paris		France	75877
2	Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II	Bonn		Germany	53105
3	Asklepios Klinik, St. Georg	Hamburg		Germany	20099
4	Universitätskliniken zu Köln Klinik III Innere Medizin	Köln		Germany	50937
5	Zentrum für Kardiologie, Universitätsmedizin Mainz	Mainz		Germany	55131
6	Munich University Clinic	Munich		Germany	81377
7	Rambam Cardiology Research Unit	Haifa		Israel	3109601
8	Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"	Catania		Italy	95123
9	San Raffaele University Hospital	Milano		Italy	20132
10	St.Antonius Ziekenhuis	Nieuwegein		Netherlands	3435
11	UniversitätsSpital Zürich	Zurich		Switzerland

Sponsors and Collaborators

• Edwards Lifesciences

Investigators

• Principal Investigator: Francesco Maisano, Prof., Universitätsspital Zürich

Study Documents (Full-Text)

None provided.

More Information

Publications

• Maisano F, La Canna G, Latib A, Denti P, Taramasso M, Kuck KH, Colombo A, Alfieri O, Guidotti A, Messika-Zeitoun D, Vahanian A. First-in-man transseptal implantation of a "surgical-like" mitral valve annuloplasty device for functional mitral regurgitation. JACC Cardiovasc Interv. 2014 Nov;7(11):1326-8. doi: 10.1016/j.jcin.2014.08.003. Epub 2014 Oct 15.
• Maisano F, Taramasso M, Nickenig G, Hammerstingl C, Vahanian A, Messika-Zeitoun D, Baldus S, Huntgeburth M, Alfieri O, Colombo A, La Canna G, Agricola E, Zuber M, Tanner FC, Topilsky Y, Kreidel F, Kuck KH. Cardioband, a transcatheter surgical-like direct mitral valve annuloplasty system: early results of the feasibility trial. Eur Heart J. 2016 Mar 7;37(10):817-25. doi: 10.1093/eurheartj/ehv603. Epub 2015 Nov 18.

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT01841554
• Other Study ID Numbers: CB1-1/CB1-2; NCT01533883
• First Posted: Apr 26, 2013
• Last Update Posted: Nov 30, 2020
• Last Verified: Nov 1, 2020

• Keywords provided by Edwards Lifesciences: Mitral Valve; Annuloplasty
• Additional relevant MeSH terms: Mitral Valve Insufficiency

Study Results

Participant Flow

Pre-assignment Detail	Of 62 patients originally enrolled, 1 excluded from full analysis data set (N=61) but included in safety analysis data set (N=62). Patient had severe MR, right heart failure (RHF), and tricuspid regurgitation (TR); determined to be a significant deviation from intended use of device. Study protocol amended to exclude severe RHF and TR.

Arm/Group Title	Single
Arm/Group Description	Multi-center, prospective study with intra-subject comparisons
Period Title: Overall Study
STARTED	61
Implanted	60
1 Year Follow Up	42
COMPLETED	42
NOT COMPLETED	19

Baseline Characteristics

Arm/Group Title	Single
Arm/Group Description	Multi-center, prospective study with intra-subject comparisons
Overall Participants	61
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	72 (7.5)
Sex: Female, Male (Count of Participants)
Female	17 27.9%
Male	44 72.1%
EuroSCORE II (Score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score]	7.3 (6.3)
New York Heart Association (NYHA) Functional Class III or IV (Count of Participants)
Count of Participants [Participants]	52 85.2%
Ischemic Etiology of Regurgitation (Count of Participants)
Count of Participants [Participants]	37 60.7%
Left Ventricule Ejection Fraction (LVEF) (Percent Fraction) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percent Fraction]	33 (11)
Previous Coronary Artery Bypass Graft (CABG) (Count of Participants)
Count of Participants [Participants]	18 29.5%
Renal Insufficiency (Count of Participants)
Count of Participants [Participants]	49 80.3%
Atrial Fibrillation (Count of Participants)
Count of Participants [Participants]	46 75.4%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects
Description	Overall rate of Major Serious Adverse Events (SAEs) and serious adverse device effects (SADEs) until hospital discharge and at post-operative 30 days.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single
Arm/Group Description	Multi-center, prospective study with intra-subject comparisons
Measure Participants	61
Death	2 3.3%
Myocardial Infarction	1 1.6%
Major Bleeding Complications	2 3.3%
Renal Failure	4 6.6%
Cardiac Tamponade	1 1.6%
Respiratory Failure	0 0%

2. Secondary Outcome

Title	Performance [6MWT]
Description	Distance in meters walked during 6 Minute Walk Test (6MWT) at baseline, 6 and 12 months.
Time Frame	Baseline, 6 and 12 months

Outcome Measure Data

Analysis Population Description

Intra-subject comparison of 18 patients who had data at all three time points (baseline, 6 and 12 months).

Arm/Group Title	Single
Arm/Group Description	Multi-center, prospective study with intra-subject comparisons
Measure Participants	18
Baseline	334.7778 (120.3957)
6 Months	393.2222 (114.4529)
1 Year	407.0556 (122.8899)

3. Secondary Outcome

Title	Performance [MLHFQ]
Description	Score on Minnesota Living with Heart Failure Questionnaire (MLHFQ). MLHFQ is composed of 21 questions relating to limitations in lifestyle associated with heart failure. Respondents use a 5 point scale from 0 to 5, with a 0 representing no limitation and 5 representing maximum limitation. The total score is computed by adding individual scores of each question. Higher scores are associated with lower quality of life.
Time Frame	Baseline, 6 and 12 months

Outcome Measure Data

Analysis Population Description

Intra-subject comparison of 27 patients who had data at all three time points (baseline, 6 and 12 months).

Arm/Group Title	Single
Arm/Group Description	Multi-center, prospective study with intra-subject comparisons
Measure Participants	27
Baseline	35.8889 (16.6579)
6 Months	16.2593 (14.9244)
1 Year	19.3333 (19.9538)

4. Secondary Outcome

Title	Performance [Intra-subject Comparison - MR Severity]
Description	All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe).
Time Frame	Baseline, discharge, 6 and 12 months

Outcome Measure Data

Analysis Population Description

Intra-subject comparison of 26 patients who were assessed for MR grade across all four time points (baseline, discharge, 6 and 12 months).

Arm/Group Title	Single
Arm/Group Description	Multi-center, prospective study with intra-subject comparisons
Measure Participants	26
Moderate - Severe (3-4+)	16 26.2%
Moderate (2+)	10 16.4%
Trace - Mild (0-1+)	0 0%
Moderate - Severe (3-4+)	1 1.6%
Moderate (2+)	5 8.2%
Trace - Mild (0-1+)	20 32.8%
Moderate - Severe (3-4+)	0 0%
Moderate (2+)	5 8.2%
Trace - Mild (0-1+)	21 34.4%
Moderate - Severe (3-4+)	0 0%
Moderate (2+)	7 11.5%
Trace - Mild (0-1+)	19 31.1%

5. Secondary Outcome

Title	Performance [Full Analysis Data Set - MR Severity]
Description	All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe).
Time Frame	Baseline, discharge, 6 and 12 months

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Single
Arm/Group Description	Multi-center, prospective study with intra-subject comparisons
Measure Participants	61
Moderate - Severe (3-4+)	45 73.8%
Moderate (2+)	16 26.2%
Trace - Mild (0-1+)	0 0%
Moderate - Severe (3-4+)	6 9.8%
Moderate (2+)	13 21.3%
Trace - Mild (0-1+)	39 63.9%
Moderate - Severe (3-4+)	3 4.9%
Moderate (2+)	11 18%
Trace - Mild (0-1+)	29 47.5%
Moderate - Severe (3-4+)	2 3.3%
Moderate (2+)	10 16.4%
Trace - Mild (0-1+)	27 44.3%

6. Other Pre-specified Outcome

Title	Reduce MR [Paired Baseline and Follow-Up]
Description	Cardioband ability to reduce mitral valve regurgitation (MR) Intra-procedure, at hospital discharge, and at 30 days. Reported as number of patients showing a reduction in MR grade greater than or equal to 1.
Time Frame	Post-adjustment, discharge, and 30 Days

Outcome Measure Data

Analysis Population Description

The data is presented as paired data for patients that have baseline data and data for each individual follow up time point. The number of patients with paired data between baseline and post-adjustment, discharge, and 30 days is 47, 50 and 46, respectively.

Arm/Group Title	Single
Arm/Group Description	Multi-center, prospective study with intra-subject comparisons
Measure Participants	58
Post-Adjustment	47 77%
Discharge	50 82%
30 Days	46 75.4%

7. Other Pre-specified Outcome

Title	Technical Feasibility of Cardioband Adjustment
Description	The ability to connect the Adjustment Tool, reduce septo-lateral dimension, and retract the Adjustment Tool with guide wire.
Time Frame	Immediately after procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single
Arm/Group Description	Multi-center, prospective study with intra-subject comparisons
Measure Participants	61
Count of Participants [Participants]	58 95.1%

8. Other Pre-specified Outcome

Title	Technical Success Rate of the Implantation of the Cardioband
Description	The ability to advance the implant, load anchors, anchor the implant to tissue, and retract the Implant Delivery System.
Time Frame	Immediately after implantation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single
Arm/Group Description	Multi-center, prospective study with intra-subject comparisons
Measure Participants	61
Count of Participants [Participants]	60 98.4%

Adverse Events

Time Frame	1 Year
Adverse Event Reporting Description	Of 62 patients originally enrolled in the study, one had severe MR, severe right heart failure (RHF), and severe tricuspid regurgitation (TR). The CEC determined this was a significant deviation from the intended use of the device. The study protocol was amended to exclude severe RHF and severe TR to emphasize this patient's condition did not fit the intended use of the device. The patient was excluded from the full analysis data set (N=61) but included in the safety analysis data set (N=62).
Arm/Group Title	Single
Arm/Group Description	Multi-center, prospective study with intra-subject comparisons
All Cause Mortality
	Single
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Single
	Affected / at Risk (%)	# Events
Total	44/62 (71%)
Cardiac disorders
Acute Myocardial Infarction	1/62 (1.6%)	1
Atrial Fibrillation	2/62 (3.2%)	2
Atrial Septal Defect	1/62 (1.6%)	1
Bundle Branch Block Left	2/62 (3.2%)	2
Cardiac Arrest	2/62 (3.2%)	2
Cardiac Failure	15/62 (24.2%)	22
Cardiac Tamponade	1/62 (1.6%)	1
Cardiogenic Shock	1/62 (1.6%)	1
Dyspnoea	1/62 (1.6%)	1
Left Ventricular Failure	1/62 (1.6%)	1
Mitral Valve Disease	4/62 (6.5%)	4
Myocardial Infarction	2/62 (3.2%)	3
Pericardial Effusion	3/62 (4.8%)	4
Sick Sinus Syndrome	1/62 (1.6%)	1
Ventricular Tachycardia	3/62 (4.8%)	3
Eye disorders
Cataract	1/62 (1.6%)	1
Gastrointestinal disorders
Melaena	1/62 (1.6%)	1
General disorders
Chest Pain	1/62 (1.6%)	1
Device Dislocation	1/62 (1.6%)	1
Multi-Organ Failure	1/62 (1.6%)	1
Oedema due to Cardiac Disease	2/62 (3.2%)	2
Systemic Inflammatory Response Syndrome	1/62 (1.6%)	1
Infections and infestations
Pneumonia	2/62 (3.2%)	2
Sepsis	1/62 (1.6%)	1
Septic Shock	2/62 (3.2%)	2
Staphylococcal Infection	1/62 (1.6%)	1
Urinary Tract Infection	1/62 (1.6%)	1
Injury, poisoning and procedural complications
Contusion	1/62 (1.6%)	1
Iatrogenic Injury	2/62 (3.2%)	2
Post Procedural Haemorrhage	1/62 (1.6%)	1
Vascular Pseudoaneurysm	1/62 (1.6%)	1
Investigations
Blood Glucose Increased	1/62 (1.6%)	2
Haemoglobin Decreased	1/62 (1.6%)	1
Troponin Increased	1/62 (1.6%)	1
Metabolism and nutrition disorders
Dehydration	1/62 (1.6%)	1
Diabetes Mellitus	1/62 (1.6%)	2
Musculoskeletal and connective tissue disorders
Meniscus Injury	1/62 (1.6%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of Eye	1/62 (1.6%)	1
Large Intestine Polyp	1/62 (1.6%)	2
Ovarian Cancer	1/62 (1.6%)	1
Nervous system disorders
Haemorrhagic Stroke	1/62 (1.6%)	1
Hemiparesis	1/62 (1.6%)	1
Ischaemic Stroke	1/62 (1.6%)	1
Syncope	1/62 (1.6%)	1
Renal and urinary disorders
Renal Failure	4/62 (6.5%)	8
Respiratory, thoracic and mediastinal disorders
Actinomycotic Pulmonary Infection	1/62 (1.6%)	1
Dyspnoea	1/62 (1.6%)	1
Pleural Effusion	1/62 (1.6%)	1
Pneumonia	1/62 (1.6%)	1
Pulmonary Hypertension	1/62 (1.6%)	1
Surgical and medical procedures
Cardiac Pacemaker Replacement	1/62 (1.6%)	1
Hospitalisation	1/62 (1.6%)	1
Implantable Defibrillator Insertion	1/62 (1.6%)	1
Vascular disorders
Air Embolism	3/62 (4.8%)	3
Hypotension	1/62 (1.6%)	1
Other (Not Including Serious) Adverse Events
	Single
	Affected / at Risk (%)	# Events
Total	21/62 (33.9%)
Cardiac disorders
Atrial Fibrillation	6/62 (9.7%)	6
General disorders
Device Fastener Issue	4/62 (6.5%)	4
Injury, poisoning and procedural complications
Post Procedural Haemorrhage	4/62 (6.5%)	4
Investigations
Haemoglobin Decreased	4/62 (6.5%)	4
Renal and urinary disorders
Renal Failure	5/62 (8.1%)	5

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.