Safety and Performance Study of the RELIANCE 4-Front Passive Fixation Lead

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01856491
• Collaborator: (none)
• Enrollment: 167
• Locations: 11
• Arm: 1
• Actual Duration (Months): 46.9
• Patients Per Site: 15.2
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Passive Fixation Defibrillation Leads.

Condition or Disease	Intervention/Treatment	Phase
Tachycardia; Ventricular Fibrillation; Ventricular Flutter	Device: RELIANCE 4-FRONT™ Passive Fixation lead implantation	N/A

Detailed Description

The RELIANCE 4-FRONT Passive Fixation Defibrillation Lead Post Market Clinical Follow-Up Study is a prospective, non-randomized, multi-center, single-group, post market clinical study to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT passive fixation defibrillation leads.

A total of 167 patients (including 10 % attrition) are required to evaluate the Primary Endpoint.

Up to 10 Investigational centers located in Europe and Israel. Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.

Lead-related complications associated with the RELIANCE 4-FRONT passive fixation lead will count toward this endpoint.

Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.

Lead-related complications associated with the RELIANCE 4-FRONT passive fixation lead will count toward this endpoint.

• Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant

• Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant

• Sensed Amplitude at 3 Months Post-Implant

• Pacing Impedance at 3 Months Post-Implant All endpoints will be assessed for the RELIANCE 4-FRONT passive fixation lead.

Clinic visits will occur at:

• Enrollment Visit (no later than 30 days prior to implant procedure)

• Implant Procedure (Day 0; all future follow ups based on this date)

• Pre-Discharge Clinic Visit (3 - 72 hours post-implant)

• One Month Clinic Visit (30±7 days)

• 3 Month Clinic Visit (91 ± 21 days)

• 6 Month Clinic Visit (180 ± 30 days)

• 12 Month Clinic Visit (365 ± 45 days)

• 18 Month Clinic Visit (545± 45 days)

• 24 Month Clinic Visit (730 ± 45 days) The study will be considered completed after all subjects have completed the 24 Month follow-up and study completion is anticipated in

1. Primary endpoint completion is anticipated after all subjects have completed the 3 Month follow-up visit. All study required visits will be completed during clinic visits.

Hypotheses testing in the RELIANCE 4-FRONT passive fixation PMCF Study will use standard statistical methodology as specified more in detail in the protocol.

Study Design

• Study Type: Interventional
• Actual Enrollment: 167 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: RELIANCE 4-FRONT™ Passive Fixation Defibrillation Lead Post Market Clinical Follow-Up (PMCF) Study
• Actual Study Start Date: Dec 16, 2013
• Actual Primary Completion Date: Nov 2, 2015
• Actual Study Completion Date: Nov 13, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: RELIANCE 4-FRONT™ Passive Fixation Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead	Device: RELIANCE 4-FRONT™ Passive Fixation lead implantation; Implantation of transvenous defibrillation lead with passive fixation mechanism.

Outcome Measures

Primary Outcome Measures

1. Complication Free Rate [3-months]

   Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.

Secondary Outcome Measures

1. Complication Free Rate [3 months through 15 months post implant]

   Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.

Other Outcome Measures

1. Pacing Threshold at 0.5 ms Pulse Width [3 Months Post-Implant]

   Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant. During the RELIANCE 4-FRONT PASSIVE fixation PMCF Study pacing threshold measurements are collected from RELIANCE 4-FRONT PASSIVE fixation leads in the standard manual fashion. At least 3 cardiac cycles at a given voltage level shall be obtained before stepping down to the next voltage level. A count of two non-capture beats is required at a given voltage level to declare a loss of capture (LOC) for any of these tests. The threshold is defined as one voltage level above the level where two non-captured beats are observed. Threshold tests must be taken with a pulse width of 0.5 ms.

2. Complication Free Rate [3 months through 24 months post implant]

   Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant

3. Sensed Amplitude [3 Months Post-Implant]

   Lead performance evaluations of the Reliance 4-FRONT PASSIVE fixation lead have been conducted in accordance with the Physician's Lead Manual. Measurements should fall within the recommended values as mentioned below: Signal Type Amplitude Pacing Threshold Impedance Pacing/Sensing ≥ 5mV ≤1.5 V 300-1200 Ω Defibrillation ≥ 1mV N/A 20-125 Ω The required data from the implant procedure for the study lead is measured with a pacing system analyzer (PSA) to verify adequate signals. Electrical performance of the lead was verified before attaching the lead to the Pulse Generator (PG). After the PG has been implanted evaluation of the study lead using the PG has been performed. Lead measurements were required unless the testing is prohibited by a subject's condition (subject has no intrinsic rhythm). In case the measurements are variable (e.g. in patients with atrial fibrillation), the most reproducible value has been collected.

4. Pacing Impedance [3 Months Post-Implant]

   Lead performance evaluations of the Reliance 4-FRONT PASSIVE fixation lead have been conducted in accordance with the Physician's Lead Manual. Measurements should fall within the recommended values as mentioned below: Signal Type Amplitude Pacing Threshold Impedance Pacing/Sensing ≥ 5mV ≤1.5 V 300-1200 Ω Defibrillation ≥ 1mV N/A 20-125 Ω The required data from the implant procedure for the study lead is measured with a pacing system analyzer (PSA) to verify adequate signals. Electrical performance of the lead was verified before attaching the lead to the Pulse Generator (PG). After the PG has been implanted evaluation of the study lead using the PG has been performed. Lead measurements were required unless the testing is prohibited by a subject's condition (subject has no intrinsic rhythm). In case the measurements are variable (e.g. in patients with atrial fibrillation), the most reproducible value has been collected.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Willing and capable of providing informed consent

• Has an indication for implantation of a single or dual chamber ICD or CRT-D system in their respective geography

• Subjects planned to be implanted with the RELIANCE 4-FRONT Passive Fixation Lead

• Willing and capable of participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol

• Age 18 or above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria:

• Known or suspected sensitivity to Dexamethasone Acetate (DXA)

• Mechanical tricuspid heart valve

• Subject is enrolled in any other concurrent study without prior written approval from Boston Scientific (BSC), with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following:

• Schedule of procedures for the RELIANCE 4-Front Study (i.e. should not cause additional or missed visits);

• RELIANCE 4-Front Study outcome (i.e. involve medications that could affect the heart rate of the subject);

• Conduct of the RELIANCE 4-Front Study per Good Clinical Practice (GCP)/ International Organization for Standardization (ISO) 14155:2011/ 21 CFR 812/ local regulations

• Currently on the active heart transplant list

• Documented life expectancy of less than 12 months

• Women of childbearing potential who are or might be pregnant at the time of study enrollment (method of assessment upon physician discretion)

• Currently requiring chronic dialysis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	German Heart Center	Berlin		Germany	13353
2	Meir Medical Center	Kfar-Saba		Israel	44281
3	Beilinson Medical Center	Petah-Tikva		Israel	49100
4	Sheba Medical Center	Tel Hashomer		Israel	52621
5	Fondazione di Ricerca e Cura 'Giovanni Paolo II	Campobasso		Italy
6	Ospedale Alessandro Manzoni	Lecco		Italy	23900
7	Clinica Mediterranea	Naples		Italy	80121
8	Ospedale Buon Consiglio	Naples		Italy	80123
9	Azienda Ospedaliero Universitaria Pisana	Pisa		Italy	56127
10	Osp. Civile S. Maria Delle Grazie	Pozzuoli		Italy	80078
11	Ospedale San Pietro Fatebenefratelli	Rome		Italy	00189

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Maria Grazia Bongiorni, MD, University Hospital Pisa, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT01856491
• Other Study ID Numbers: C1868
• First Posted: May 17, 2013
• Last Update Posted: Apr 30, 2019
• Last Verified: Apr 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Boston Scientific Corporation: RELIANCE 4-FRONT; Implantable Cardioverter Defibrillator (ICD); Cardiac Resynchronization Therapy - Defibrillator (CRT-D)
• Additional relevant MeSH terms: Tachycardia; Ventricular Fibrillation; Ventricular Flutter

Study Results

Participant Flow

Arm/Group Title	RELIANCE 4-FRONT™ Passive Fixation
Arm/Group Description	Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism.
Period Title: Overall Study
STARTED	167
COMPLETED	152
NOT COMPLETED	15

Baseline Characteristics

Arm/Group Title	RELIANCE 4-FRONT™ Passive Fixation
Arm/Group Description	Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism.
Overall Participants	167
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.90 (10.47)
Sex: Female, Male (Count of Participants)
Female	33 19.8%
Male	134 80.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	166 99.4%
More than one race	0 0%
Unknown or Not Reported	1 0.6%

Outcome Measures

1. Primary Outcome

Title	Complication Free Rate
Description	Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.
Time Frame	3-months

Outcome Measure Data

Analysis Population Description

167 have been enrolled. 165 were included in the analysis because for 2 patients the leads have not been implanted

Arm/Group Title	RELIANCE 4-FRONT™ Passive Fixation
Arm/Group Description	Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism.
Measure Participants	165
Number (95% Confidence Interval) [percentage of patients without event]	97.5

2. Secondary Outcome

Title	Complication Free Rate
Description	Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.
Time Frame	3 months through 15 months post implant

Outcome Measure Data

Analysis Population Description

Subjects were eligible for the secondary endpoint analysis if their date of last follow-up was ≥92 days post-implant procedure.

Arm/Group Title	RELIANCE 4-FRONT™ Passive Fixation
Arm/Group Description	Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism.
Measure Participants	158
Number (95% Confidence Interval) [percentage of patients without events]	99.4

3. Other Pre-specified Outcome

Title	Pacing Threshold at 0.5 ms Pulse Width
Description	Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant. During the RELIANCE 4-FRONT PASSIVE fixation PMCF Study pacing threshold measurements are collected from RELIANCE 4-FRONT PASSIVE fixation leads in the standard manual fashion. At least 3 cardiac cycles at a given voltage level shall be obtained before stepping down to the next voltage level. A count of two non-capture beats is required at a given voltage level to declare a loss of capture (LOC) for any of these tests. The threshold is defined as one voltage level above the level where two non-captured beats are observed. Threshold tests must be taken with a pulse width of 0.5 ms.
Time Frame	3 Months Post-Implant

Outcome Measure Data

Analysis Population Description

167 have been enrolled. 138 were included in the analysis because we have the lead measurements for those number of patients collected .

Arm/Group Title	RELIANCE 4-FRONT™ Passive Fixation
Arm/Group Description	Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism.
Measure Participants	138
Mean (Standard Deviation) [Volt]	0.48 (0.59)

4. Other Pre-specified Outcome

Title	Complication Free Rate
Description	Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant
Time Frame	3 months through 24 months post implant

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	RELIANCE 4-FRONT™ Passive Fixation
Arm/Group Description	Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism.
Measure Participants	158
Number (95% Confidence Interval) [percentage of patients without events]	99.4

5. Other Pre-specified Outcome

Title	Sensed Amplitude
Description	Lead performance evaluations of the Reliance 4-FRONT PASSIVE fixation lead have been conducted in accordance with the Physician's Lead Manual. Measurements should fall within the recommended values as mentioned below: Signal Type Amplitude Pacing Threshold Impedance Pacing/Sensing ≥ 5mV ≤1.5 V 300-1200 Ω Defibrillation ≥ 1mV N/A 20-125 Ω The required data from the implant procedure for the study lead is measured with a pacing system analyzer (PSA) to verify adequate signals. Electrical performance of the lead was verified before attaching the lead to the Pulse Generator (PG). After the PG has been implanted evaluation of the study lead using the PG has been performed. Lead measurements were required unless the testing is prohibited by a subject's condition (subject has no intrinsic rhythm). In case the measurements are variable (e.g. in patients with atrial fibrillation), the most reproducible value has been collected.
Time Frame	3 Months Post-Implant

Outcome Measure Data

Analysis Population Description

167 patients were enrolled. From 141 patients we could collected the sensed amplitude at 3 months

Arm/Group Title	RELIANCE 4-FRONT™ Passive Fixation
Arm/Group Description	Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism.
Measure Participants	141
Mean (Standard Deviation) [mVolt]	18.5 (5.7)

6. Other Pre-specified Outcome

Title	Pacing Impedance
Description	Lead performance evaluations of the Reliance 4-FRONT PASSIVE fixation lead have been conducted in accordance with the Physician's Lead Manual. Measurements should fall within the recommended values as mentioned below: Signal Type Amplitude Pacing Threshold Impedance Pacing/Sensing ≥ 5mV ≤1.5 V 300-1200 Ω Defibrillation ≥ 1mV N/A 20-125 Ω The required data from the implant procedure for the study lead is measured with a pacing system analyzer (PSA) to verify adequate signals. Electrical performance of the lead was verified before attaching the lead to the Pulse Generator (PG). After the PG has been implanted evaluation of the study lead using the PG has been performed. Lead measurements were required unless the testing is prohibited by a subject's condition (subject has no intrinsic rhythm). In case the measurements are variable (e.g. in patients with atrial fibrillation), the most reproducible value has been collected.
Time Frame	3 Months Post-Implant

Outcome Measure Data

Analysis Population Description

167 patients have been enrolled. For 150 patients we were able to collect the 3 month pacing impedance

Arm/Group Title	RELIANCE 4-FRONT™ Passive Fixation
Arm/Group Description	Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism.
Measure Participants	150
Mean (Standard Deviation) [Ohm]	474 (106)

Adverse Events

Time Frame	3-month follow-up data
Arm/Group Title	RELIANCE 4-FRONT™ Passive Fixation
Arm/Group Description	Single arm, all patients will be implanted with the RELIANCE 4-FRONT™ Passive Fixation lead RELIANCE 4-FRONT™ Passive Fixation lead implantation: Implantation of transvenous defibrillation lead with passive fixation mechanism.
All Cause Mortality
	RELIANCE 4-FRONT™ Passive Fixation
	Affected / at Risk (%)	# Events
Total	4/167 (2.4%)
Serious Adverse Events
	RELIANCE 4-FRONT™ Passive Fixation
	Affected / at Risk (%)	# Events
Total	84/167 (50.3%)
Blood and lymphatic system disorders
Abnormal laboratory values	3/167 (1.8%)	4
Hematological	5/167 (3%)	7
Cardiac disorders
Inappropriate tachy therapy - SVT	1/167 (0.6%)	1
Chest pain	1/167 (0.6%)	1
Ventricular fibrillation (VF)	3/167 (1.8%)	3
Ventricular tachycardia (VT)	3/167 (1.8%)	6
Atrial flutter	3/167 (1.8%)	3
Other SVT (AVRT, AVNRT, EAT etc.)	1/167 (0.6%)	1
Chest pain - Heart failure	3/167 (1.8%)	3
Dyspnea - Heart failure	8/167 (4.8%)	11
Peripheral edema - Heart failure	1/167 (0.6%)	1
Pulmonary edema - Heart failure	4/167 (2.4%)	6
Heart failure symptoms - Unspecified	6/167 (3.6%)	8
Multiple heart failure symptoms	4/167 (2.4%)	5
Multi-system failure - Heart failure	5/167 (3%)	5
RELATED TO ISCHEMIA	1/167 (0.6%)	1
Myocardial infarction	6/167 (3.6%)	6
Mitral regurgitation	1/167 (0.6%)	2
Syncope	3/167 (1.8%)	4
Dizziness	2/167 (1.2%)	3
Chest pain - Ischemic	1/167 (0.6%)	2
Chest pain - Other	6/167 (3.6%)	7
Endocrine disorders
Endocrine	2/167 (1.2%)	2
Gastrointestinal disorders
Gastrointestinal	10/167 (6%)	11
General disorders
Conductor coil fracture - RA	1/167 (0.6%)	1
Elevated threshold - RV	2/167 (1.2%)	2
Dislodgment - Unable to capture - LV	1/167 (0.6%)	1
Fatigue	1/167 (0.6%)	1
Hematoma - Unrelated to procedure or device	1/167 (0.6%)	1
Death	4/167 (2.4%)	4
Fever	2/167 (1.2%)	2
Head, eyes, ears, nose, throat (HEENT)	2/167 (1.2%)	2
Multi-system failure	1/167 (0.6%)	1
Infections and infestations
Infection (> 30 days post-implant)	3/167 (1.8%)	3
Post-surgical infection (<= 30 days post-implant)	2/167 (1.2%)	2
Systemic infection	2/167 (1.2%)	2
Injury, poisoning and procedural complications
Pneumothorax - Procedure	2/167 (1.2%)	3
Physical trauma	2/167 (1.2%)	2
Musculoskeletal and connective tissue disorders
Musculoskeletal	1/167 (0.6%)	2
Nervous system disorders
Neurological	2/167 (1.2%)	2
Psychiatric disorders
Psychological effect due to device therapy	1/167 (0.6%)	2
Renal and urinary disorders
Genitourinary	7/167 (4.2%)	14
Renal	7/167 (4.2%)	9
Respiratory, thoracic and mediastinal disorders
Pulmonary	9/167 (5.4%)	13
sleep apnea	1/167 (0.6%)	1
Skin and subcutaneous tissue disorders
Erosion	1/167 (0.6%)	1
Post-surgical wound discomfort	1/167 (0.6%)	1
Hematoma - Pocket (<=30 days post-implant)	4/167 (2.4%)	4
Integumentary	1/167 (0.6%)	1
Vascular disorders
Hypotension	1/167 (0.6%)	1
Hypertension	1/167 (0.6%)	1
Coronary Artery Disease	2/167 (1.2%)	2
Coronary artery disease	1/167 (0.6%)	1
Peripheral vascular disease	3/167 (1.8%)	4
Intermittent claudication	1/167 (0.6%)	1
Cerebrovascular accident (CVA)	6/167 (3.6%)	6
Pulmonary embolism (PE)	1/167 (0.6%)	1
Intracardiac thrombus	1/167 (0.6%)	1
Other (Not Including Serious) Adverse Events
	RELIANCE 4-FRONT™ Passive Fixation
	Affected / at Risk (%)	# Events
Total	55/167 (32.9%)
Blood and lymphatic system disorders
Hematological	1/167 (0.6%)	1
Cardiac disorders
Inappropriate tachy therapy - SVT	4/167 (2.4%)	5
Inappropriate tachy therapy - Other	1/167 (0.6%)	1
Inadvertent VT/VF	2/167 (1.2%)	2
Elevated threshold - RA	1/167 (0.6%)	1
Elevated threshold - RV	1/167 (0.6%)	1
Ventricular fibrillation (VF)	2/167 (1.2%)	2
Ventricular tachycardia (VT)	1/167 (0.6%)	1
Atrial fibrillation (AF)	4/167 (2.4%)	5
Other SVT (AVRT, AVNRT, EAT etc.)	3/167 (1.8%)	3
Syncope - Heart failure	1/167 (0.6%)	1
Chest pain - Heart failure	1/167 (0.6%)	1
Dyspnea - Heart failure	7/167 (4.2%)	8
Multiple heart failure symptoms	1/167 (0.6%)	1
Hypertension - Heart failure	1/167 (0.6%)	1
Chest pain - Ischemic	1/167 (0.6%)	1
Chest pain - Other	7/167 (4.2%)	7
Palpitations	3/167 (1.8%)	3
Endocrine disorders
Endocrine	2/167 (1.2%)	2
Gastrointestinal disorders
Gastrointestinal	5/167 (3%)	10
General disorders
Not yet classified	3/167 (1.8%)	4
Fatigue	1/167 (0.6%)	1
Physical trauma	6/167 (3.6%)	6
Head, eyes, ears, nose, throat (HEENT)	10/167 (6%)	12
Cancer	2/167 (1.2%)	4
medication side effect	1/167 (0.6%)	1
Injury, poisoning and procedural complications
Hematoma - Pocket (<=30 days post-implant)	2/167 (1.2%)	2
Musculoskeletal and connective tissue disorders
Musculoskeletal	6/167 (3.6%)	12
Psychiatric disorders
Psychological	1/167 (0.6%)	1
Renal and urinary disorders
Genitourinary	4/167 (2.4%)	5
Renal	1/167 (0.6%)	1
Respiratory, thoracic and mediastinal disorders
Pulmonary	2/167 (1.2%)	2
Skin and subcutaneous tissue disorders
Integumentary	3/167 (1.8%)	5
pain in device pocket	1/167 (0.6%)	1
Surgical and medical procedures
Post-surgical wound discomfort	1/167 (0.6%)	1
Hemorrhage	1/167 (0.6%)	1
Vascular disorders
Coronary venous dissection	1/167 (0.6%)	1

Limitations/Caveats

Sample size is rather small and the power of the study is only 80%

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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.