Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort

• Sponsor: Medtronic Cardiovascular (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00740870
• Collaborator: (none)
• Enrollment: 171
• Locations: 5
• Arm: 1
• Actual Duration (Months): 163.6
• Patients Per Site: 34.2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. The secondary objectives are to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Defects; Dysfunctional Right Ventricular Outflow Tract Conduits	Device: Transcatheter Pulmonary Valve replacement	N/A

Detailed Description

The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. The secondary objectives is to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.

Study Design

• Study Type: Interventional
• Actual Enrollment: 171 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Implantation of the Medtronic Melody Transcatheter Pulmonary Valve in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Feasibility Study
• Actual Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: Aug 21, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Melody TPV Implant Melody Transcatheter Pulmonary Valve implanted into a dysfunctional RVOT Conduit.	Device: Transcatheter Pulmonary Valve replacement; Transcatheter valve implantation into a RVOT conduit in patients with complex congenital heart defects where the conduit has become dysfunctional and where the patient needs invasive intervention.; Other Names: Melody Transcatheter Pulmonary Valve

Outcome Measures

Primary Outcome Measures

1. Kaplan-Meier Freedom From TPV Dysfunction [5 years]

   To assess whether long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. This study is designed to test the null hypothesis that the true freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is less than or equal to 36% (PControl). To reject the null hypothesis means that freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is greater than 36% (PControl). The null (H0) and alternative (HA) hypotheses are written as follows:H0: PMelody ≤ PControl and HA: PMelody > PControl. TPV dysfunction is a composite outcome defined as the following: Hemodynamic dysfunction of the TPV Moderate or greater pulmonary regurgitation, and/or Mean Right Ventricular Outflow Tract (RVOT) gradient greater than 40 mmHg RVOT reoperation for conduit dysfunction or device-related reasons Catheter re-intervention on the TPV

Secondary Outcome Measures

1. Freedom From TPV Dysfunction at 10 Years [10 years]

   The outcome measure for this objective is TPV dysfunction, which is a composite outcome defined as RVOT reoperation for conduit dysfunction or device-related reasons, catheter re-intervention on the TPV, or hemodynamic dysfunction of the TPV (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient greater than 40 mmHg).

2. Procedural Success [Within 24 Hours post implant]

   Procedural success is a composite outcome defined as: Melody TPV fixated within the desired location Right Ventricle (RV) - Pulmonary Artery (PA) peak-to-peak gradient (measured in the catheterization lab) less than 35 mmHg post-implant Less than mild pulmonary regurgitation by angiography post-implant Free of explant at 24 hours post-implant

3. Serious Procedural Adverse Event (AE) [5 years]

   A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).

4. Serious Procedural Adverse Event (AE) [10 years]

   A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).

5. Serious Device-related Adverse Event [5 years]

   A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).

6. Serious Device-related Adverse Event [10 years]

   A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).

7. Kaplan-Meier Freedom From Major Stent Fracture at 5 Years [5 years]

   Major stent fracture is defined as a stent fracture requiring intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

8. Kaplan-Meier Freedom From Major Stent Fracture at 10 Years [10 years]

   Major stent fracture is defined as a stent fracture requiring intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

9. Kaplan-Meier Freedom From Catheter Re-intervention on TPV [5 years]

   Catheter Re-intervention is defined as: any catheter-based intervention involving the TPV, including balloon dilatation, stenting, or placement of a second TPV

10. Kaplan-Meier Freedom From Catheter Re-intervention on TPV [10 years]

    Catheter Re-intervention is defined as: any catheter-based intervention involving the TPV, including balloon dilatation, stenting, or placement of a second TPV

11. Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit [5 years]

    Surgical Replacement of the RVOT Conduit is defined as any surgical procedure to repair, alter, or explant the TPV

12. Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit [10 years]

    Surgical Replacement of the RVOT Conduit is defined as any surgical procedure to repair, alter, or explant the TPV

13. Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related) [5 years]

    Deaths is defined as all-cause, procedural and device-related events at 5 years

14. Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related) [10 years]

    Deaths is defined as all-cause, procedural and device-related events at 10 years

15. Functional Assessment (NYHA Classification) [6 Months]

    Improvement in Functional Assessment (NYHA Classification) at 6 months post implant.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age greater than or equal to 5 years of age

• Weight greater than or equal to 30 kilograms

• Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted, or a stented bioprosthesis with a rigid circumferential sewing ring in the RVOT that has an internal diameter greater than or equal to 18 mm and less than or equal to 22 mm when originally implanted.

• Any of the following by transthoracic echocardiography:

• For patients in New York Heart Association (NYHA) Classification II, III, or IV: Moderate (3+) or severe (4+) pulmonary regurgitation AND/OR Mean RVOT gradient greater than or equal to 35 mmHg

• For patients in NYHA Classification I:Severe (4+) pulmonary regurgitation with RV dilatation or dysfunction AND/OR Mean RVOT gradient greater or equal to 40 mmHg

Exclusion Criteria:

• Active endocarditis

• Major or progressive non-cardiac disease (liver failure, renal failure, cancer)that has a life expectancy of less than one year

• Patient or guardian unwilling or unable to provide written informed consent or comply with follow-up requirements

• Obstruction of the central veins (including the superior and inferior vena cava, bilateral iliac veins) such that the delivery system cannot be advanced to the heart via transvenous approach from either femoral vein or internal jugular vein

• Positive urine or serum pregnancy test 24 hours prior to procedure in female patients of child bearing potential

• Known intravenous drug abuse

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nicklaus Children's Hospital	Miami	Florida	United States	33155
2	Children's Hospital Boston	Boston	Massachusetts	United States	02115
3	Children's Hospital of NY-Presbyterian	New York	New York	United States	10032
4	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
5	Seattle Children's and Regional Hospital	Seattle	Washington	United States	98105

Sponsors and Collaborators

• Medtronic Cardiovascular

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiovascular
• ClinicalTrials.gov Identifier: NCT00740870
• Other Study ID Numbers: G050186
• First Posted: Aug 25, 2008
• Last Update Posted: Apr 13, 2021
• Last Verified: Mar 1, 2021

• Additional relevant MeSH terms: Heart Defects, Congenital

Study Results

Participant Flow

Arm/Group Title	Enrolled
Arm/Group Description	All subjects enrolled (n=171)
Period Title: Overall Study
STARTED	171
COMPLETED	150
NOT COMPLETED	21

Baseline Characteristics

Arm/Group Title	Enrolled Cohort
Arm/Group Description	All subjects enrolled
Overall Participants	171
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	21.8 (9.8)
Sex: Female, Male (Count of Participants)
Female	64 37.4%
Male	107 62.6%
Region of Enrollment (participants) [Number]
United States	171 100%

Outcome Measures

1. Primary Outcome

Title	Kaplan-Meier Freedom From TPV Dysfunction
Description	To assess whether long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. This study is designed to test the null hypothesis that the true freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is less than or equal to 36% (PControl). To reject the null hypothesis means that freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is greater than 36% (PControl). The null (H0) and alternative (HA) hypotheses are written as follows:H0: PMelody ≤ PControl and HA: PMelody > PControl. TPV dysfunction is a composite outcome defined as the following: Hemodynamic dysfunction of the TPV Moderate or greater pulmonary regurgitation, and/or Mean Right Ventricular Outflow Tract (RVOT) gradient greater than 40 mmHg RVOT reoperation for conduit dysfunction or device-related reasons Catheter re-intervention on the TPV
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.

Arm/Group Title	Implanted >24 Hour Cohort
Arm/Group Description	The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Measure Participants	149
Number (95% Confidence Interval) [percentage of subjects]	72.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Implanted >24 Hour Cohort
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Z test
	Comments
Method of Estimation	Estimation Parameter	Kaplan-Meier Rate
	Estimated Value	74.2
	Confidence Interval	(1-Sided) 95%; 67.1 to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Freedom From TPV Dysfunction at 10 Years
Description	The outcome measure for this objective is TPV dysfunction, which is a composite outcome defined as RVOT reoperation for conduit dysfunction or device-related reasons, catheter re-intervention on the TPV, or hemodynamic dysfunction of the TPV (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient greater than 40 mmHg).
Time Frame	10 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Implanted >24 Hour Cohort
Arm/Group Description	The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Measure Participants	149
Number (95% Confidence Interval) [Percentage]	52.9

3. Secondary Outcome

Title	Procedural Success
Description	Procedural success is a composite outcome defined as: Melody TPV fixated within the desired location Right Ventricle (RV) - Pulmonary Artery (PA) peak-to-peak gradient (measured in the catheterization lab) less than 35 mmHg post-implant Less than mild pulmonary regurgitation by angiography post-implant Free of explant at 24 hours post-implant
Time Frame	Within 24 Hours post implant

Outcome Measure Data

Analysis Population Description

The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).

Arm/Group Title	Attempted Implant Cohort
Arm/Group Description	The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).
Measure Participants	150
Number [percentage of subjects]	94.7

4. Secondary Outcome

Title	Serious Procedural Adverse Event (AE)
Description	A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.

Arm/Group Title	Catheterized Cohort
Arm/Group Description	The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
Measure Participants	167
Number [Percent of subjects]	12.6

5. Secondary Outcome

Title	Serious Procedural Adverse Event (AE)
Description	A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).
Time Frame	10 years

Outcome Measure Data

Analysis Population Description

The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.

Arm/Group Title	Catheterized Cohort
Arm/Group Description	The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
Measure Participants	167
Number [percentage of subjects]	13.2

6. Secondary Outcome

Title	Serious Device-related Adverse Event
Description	A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.

Arm/Group Title	Implanted Cohort
Arm/Group Description	The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.
Measure Participants	150
Number [Percentage of subjects]	28

7. Secondary Outcome

Title	Serious Device-related Adverse Event
Description	A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).
Time Frame	10 years

Outcome Measure Data

Analysis Population Description

The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.

Arm/Group Title	Implanted Cohort
Arm/Group Description	The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.
Measure Participants	150
Number [percentage of subjects]	41.3

8. Secondary Outcome

Title	Kaplan-Meier Freedom From Major Stent Fracture at 5 Years
Description	Major stent fracture is defined as a stent fracture requiring intervention to prevent permanent impairment of a body function or permanent damage to a body structure.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.

Arm/Group Title	Implanted >24 Hour Cohort
Arm/Group Description	The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Measure Participants	149
Number (95% Confidence Interval) [percentage of subjects]	84.3

9. Secondary Outcome

Title	Kaplan-Meier Freedom From Major Stent Fracture at 10 Years
Description	Major stent fracture is defined as a stent fracture requiring intervention to prevent permanent impairment of a body function or permanent damage to a body structure.
Time Frame	10 years

Outcome Measure Data

Analysis Population Description

The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.

Arm/Group Title	Implanted >24 Hour Cohort
Arm/Group Description	The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Measure Participants	149
Number (95% Confidence Interval) [percentage of subjects]	83.7

10. Secondary Outcome

Title	Kaplan-Meier Freedom From Catheter Re-intervention on TPV
Description	Catheter Re-intervention is defined as: any catheter-based intervention involving the TPV, including balloon dilatation, stenting, or placement of a second TPV
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.

Arm/Group Title	Implanted >24 Hour Cohort
Arm/Group Description	The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Measure Participants	149
Number (95% Confidence Interval) [percentage of subjects]	81

11. Secondary Outcome

Title	Kaplan-Meier Freedom From Catheter Re-intervention on TPV
Description	Catheter Re-intervention is defined as: any catheter-based intervention involving the TPV, including balloon dilatation, stenting, or placement of a second TPV
Time Frame	10 years

Outcome Measure Data

Analysis Population Description

The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.

Arm/Group Title	Implanted >24 Hour Cohort
Arm/Group Description	The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Measure Participants	149
Number (95% Confidence Interval) [percentage of subjects]	73.1

12. Secondary Outcome

Title	Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit
Description	Surgical Replacement of the RVOT Conduit is defined as any surgical procedure to repair, alter, or explant the TPV
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.

Arm/Group Title	Implanted >24 Hour Cohort
Arm/Group Description	The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Measure Participants	149
Number (95% Confidence Interval) [percentage of subjects]	92.2

13. Secondary Outcome

Title	Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit
Description	Surgical Replacement of the RVOT Conduit is defined as any surgical procedure to repair, alter, or explant the TPV
Time Frame	10 years

Outcome Measure Data

Analysis Population Description

The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.

Arm/Group Title	Implanted >24 Hour Cohort
Arm/Group Description	The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Measure Participants	149
Number (95% Confidence Interval) [percentage of subjects]	78.9

14. Secondary Outcome

Title	Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related)
Description	Deaths is defined as all-cause, procedural and device-related events at 5 years
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Catheterized Cohort
Arm/Group Description	The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
Measure Participants	167
Number (95% Confidence Interval) [percentage of subjects]	96.5

15. Secondary Outcome

Title	Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related)
Description	Deaths is defined as all-cause, procedural and device-related events at 10 years
Time Frame	10 years

Outcome Measure Data

Analysis Population Description

The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.

Arm/Group Title	Catheterized Cohort
Arm/Group Description	The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
Measure Participants	167
Number (95% Confidence Interval) [percentage of subjects]	90.2

16. Secondary Outcome

Title	Functional Assessment (NYHA Classification)
Description	Improvement in Functional Assessment (NYHA Classification) at 6 months post implant.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours and had paired data from pre-implant to 6 months post-implant.

Arm/Group Title	Implanted >24 Hour Cohort
Arm/Group Description	The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
Measure Participants	143
Improved	102 59.6%
No Change	39 22.8%
Worsened	1 0.6%
Died	1 0.6%

Adverse Events

Time Frame	Adverse event data were collected from the time of consent through end of participation in the study.
Adverse Event Reporting Description	Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
Arm/Group Title	Catheterized Cohort
Arm/Group Description	The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
All Cause Mortality
	Catheterized Cohort
	Affected / at Risk (%)	# Events
Total	8/167 (4.8%)
Serious Adverse Events
	Catheterized Cohort
	Affected / at Risk (%)	# Events
Total	106/167 (63.5%)
Blood and lymphatic system disorders
Thrombocytopenia	1/167 (0.6%)	1
Cardiac disorders
Aortic Regurgitation	3/167 (1.8%)	3
Arrhythmia	2/167 (1.2%)	2
Atrial Fibrillation	2/167 (1.2%)	2
Atrial Flutter	9/167 (5.4%)	13
Cardiac Arrest	4/167 (2.4%)	4
Cardiac Disorder	11/167 (6.6%)	13
Cardiac Tamponade	1/167 (0.6%)	1
Complete Heart Block	3/167 (1.8%)	3
Congestive Heart Failure	4/167 (2.4%)	7
Intracardiac Mass	1/167 (0.6%)	2
Premature Ventricular Ectopic Beats	2/167 (1.2%)	2
Pulmonary Valve Disease	2/167 (1.2%)	2
Pulmonary Valve Regurgitation	3/167 (1.8%)	3
Pulmonary Valve Stenosis	33/167 (19.8%)	56
Supraventricular Tachycardia	1/167 (0.6%)	1
Tricuspid Regurgitation	5/167 (3%)	8
Ventricular Fibrillation	2/167 (1.2%)	3
Ventricular Tachycardia	10/167 (6%)	12
Gastrointestinal disorders
Gastrointestinal Disorder	4/167 (2.4%)	5
General disorders
Adverse Event	15/167 (9%)	23
Chest Pain	3/167 (1.8%)	4
Device Complication	10/167 (6%)	10
Device Rupture	3/167 (1.8%)	3
Fever	2/167 (1.2%)	2
Multi Organ Failure	2/167 (1.2%)	2
Prosthetic Cardiac Valve Malfunction	1/167 (0.6%)	1
Prosthetic Tissue Defect	1/167 (0.6%)	1
Stent Strut Fracture	23/167 (13.8%)	28
Infections and infestations
Endocarditis	11/167 (6.6%)	18
Infection	8/167 (4.8%)	11
Pneumonia	2/167 (1.2%)	2
Prosthetic Valve Endocarditis	18/167 (10.8%)	33
Sepsis	9/167 (5.4%)	9
Urinary Tract Infection	2/167 (1.2%)	2
Injury, poisoning and procedural complications
Procedural Complication	2/167 (1.2%)	2
Procedural Hemorrhage	1/167 (0.6%)	1
Procedural Hypotension	1/167 (0.6%)	2
Vascular Access Complication	1/167 (0.6%)	1
Prosthetic Cardiac Valve Thrombosis	1/167 (0.6%)	1
Nervous system disorders
Central Nervous System Disorder	4/167 (2.4%)	4
Cva	1/167 (0.6%)	1
Headache	1/167 (0.6%)	1
Syncope	4/167 (2.4%)	5
Renal and urinary disorders
Acute Renal Failure	3/167 (1.8%)	3
Renal Disorder	1/167 (0.6%)	2
Renal Insufficiency	1/167 (0.6%)	1
Respiratory, thoracic and mediastinal disorders
Asthma	1/167 (0.6%)	1
Hemothorax	2/167 (1.2%)	2
Pneumothorax	2/167 (1.2%)	2
Pulmonary Thromboembolism	2/167 (1.2%)	2
Respiratory Disorder	7/167 (4.2%)	8
Respiratory Failure	1/167 (0.6%)	1
Respiratory Insufficiency	1/167 (0.6%)	1
Skin and subcutaneous tissue disorders
Rash	1/167 (0.6%)	1
Vascular disorders
Embolism	1/167 (0.6%)	1
Hemorrhage	1/167 (0.6%)	1
Vascular Dissection	1/167 (0.6%)	1
Venous Thrombosis	1/167 (0.6%)	2
Vessel Perforation	2/167 (1.2%)	2
Other (Not Including Serious) Adverse Events
	Catheterized Cohort
	Affected / at Risk (%)	# Events
Total	112/167 (67.1%)
Blood and lymphatic system disorders
Hemolysis	9/167 (5.4%)	15
Cardiac disorders
Arrhythmia	10/167 (6%)	12
Cardiac Disorder	16/167 (9.6%)	18
Palpitations	16/167 (9.6%)	23
Tricuspid Regurgitation	12/167 (7.2%)	14
Gastrointestinal disorders
Gastrointestinal Disorder	9/167 (5.4%)	9
General disorders
Adverse Event	35/167 (21%)	69
Chest Pain	17/167 (10.2%)	25
Stent Strut Fracture	51/167 (30.5%)	73
Infections and infestations
Infection	9/167 (5.4%)	15
Nervous system disorders
Central Nervous System Disorder	9/167 (5.4%)	10
Headache	11/167 (6.6%)	16
Renal and urinary disorders
Renal Disorder	14/167 (8.4%)	29
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder	16/167 (9.6%)	21

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.