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Trial record 47 of 132 for:    "Paroxysmal Ventricular Fibrillation"

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

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ClinicalTrials.gov Identifier: NCT01856491
Recruitment Status : Completed
First Posted : May 17, 2013
Results First Posted : November 20, 2017
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Tachycardia
Ventricular Fibrillation
Ventricular Flutter
Intervention Device: RELIANCE 4-FRONT™ Passive Fixation lead implantation
Enrollment 167
Recruitment Details  
Pre-assignment Details  
Arm/Group Title RELIANCE 4-FRONT™ Passive Fixation
Hide 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
Arm/Group Title RELIANCE 4-FRONT™ Passive Fixation
Hide 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 Number of Baseline Participants 167
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 167 participants
66.90  (10.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants
Female
33
  19.8%
Male
134
  80.2%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
166
  99.4%
More than one race
0
   0.0%
Unknown or Not Reported
1
   0.6%
[1]
Measure Description: Patient demographic data has been collected during the enrollment visit. No study-specific collection was conducted prior to consent.
1.Primary Outcome
Title Complication Free Rate
Hide Description Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.
Time Frame 3-months
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 165
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients without event
97.5
(94.4 to 100)
2.Secondary Outcome
Title Complication Free Rate
Hide Description Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.
Time Frame 3 months through 15 months post implant
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 158
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients without events
99.4
(95 to 100)
3.Other Pre-specified Outcome
Title Pacing Threshold at 0.5 ms Pulse Width
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 138
Mean (Standard Deviation)
Unit of Measure: Volt
0.48  (0.59)
4.Other Pre-specified Outcome
Title Complication Free Rate
Hide Description Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant
Time Frame 3 months through 24 months post implant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RELIANCE 4-FRONT™ Passive Fixation
Hide 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 Number of Participants Analyzed 158
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients without events
99.4
(95 to 100)
5.Other Pre-specified Outcome
Title Sensed Amplitude
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 141
Mean (Standard Deviation)
Unit of Measure: mVolt
18.5  (5.7)
6.Other Pre-specified Outcome
Title Pacing Impedance
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 150
Mean (Standard Deviation)
Unit of Measure: Ohm
474  (106)
Time Frame 3-month follow-up data
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RELIANCE 4-FRONT™ Passive Fixation
Hide 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 (%)
Total   4/167 (2.40%)    
Show Serious Adverse Events Hide Serious Adverse Events
RELIANCE 4-FRONT™ Passive Fixation
Affected / at Risk (%) # Events
Total   84/167 (50.30%)    
Blood and lymphatic system disorders   
Abnormal laboratory values  1  3/167 (1.80%)  4
Hematological  1  5/167 (2.99%)  7
Cardiac disorders   
Inappropriate tachy therapy - SVT  1  1/167 (0.60%)  1
Chest pain  1  1/167 (0.60%)  1
Ventricular fibrillation (VF)  1  3/167 (1.80%)  3
Ventricular tachycardia (VT)  1  3/167 (1.80%)  6
Atrial flutter  1  3/167 (1.80%)  3
Other SVT (AVRT, AVNRT, EAT etc.)  1  1/167 (0.60%)  1
Chest pain - Heart failure  1  3/167 (1.80%)  3
Dyspnea - Heart failure  1  8/167 (4.79%)  11
Peripheral edema - Heart failure  1  1/167 (0.60%)  1
Pulmonary edema - Heart failure  1  4/167 (2.40%)  6
Heart failure symptoms - Unspecified  1  6/167 (3.59%)  8
Multiple heart failure symptoms  1  4/167 (2.40%)  5
Multi-system failure - Heart failure  1  5/167 (2.99%)  5
RELATED TO ISCHEMIA  1  1/167 (0.60%)  1
Myocardial infarction  1  6/167 (3.59%)  6
Mitral regurgitation  1  1/167 (0.60%)  2
Syncope  1  3/167 (1.80%)  4
Dizziness  1  2/167 (1.20%)  3
Chest pain - Ischemic  1  1/167 (0.60%)  2
Chest pain - Other  1  6/167 (3.59%)  7
Endocrine disorders   
Endocrine  1  2/167 (1.20%)  2
Gastrointestinal disorders   
Gastrointestinal  1  10/167 (5.99%)  11
General disorders   
Conductor coil fracture - RA  1  1/167 (0.60%)  1
Elevated threshold - RV  1  2/167 (1.20%)  2
Dislodgment - Unable to capture - LV  1  1/167 (0.60%)  1
Fatigue  1  1/167 (0.60%)  1
Hematoma - Unrelated to procedure or device  1  1/167 (0.60%)  1
Death  1  4/167 (2.40%)  4
Fever  1  2/167 (1.20%)  2
Head, eyes, ears, nose, throat (HEENT)  1  2/167 (1.20%)  2
Multi-system failure  1  1/167 (0.60%)  1
Infections and infestations   
Infection (> 30 days post-implant)  1  3/167 (1.80%)  3
Post-surgical infection (<= 30 days post-implant)  1  2/167 (1.20%)  2
Systemic infection  1  2/167 (1.20%)  2
Injury, poisoning and procedural complications   
Pneumothorax - Procedure  1  2/167 (1.20%)  3
Physical trauma  1  2/167 (1.20%)  2
Musculoskeletal and connective tissue disorders   
Musculoskeletal  1  1/167 (0.60%)  2
Nervous system disorders   
Neurological  1  2/167 (1.20%)  2
Psychiatric disorders   
Psychological effect due to device therapy  1  1/167 (0.60%)  2
Renal and urinary disorders   
Genitourinary  1  7/167 (4.19%)  14
Renal  1  7/167 (4.19%)  9
Respiratory, thoracic and mediastinal disorders   
Pulmonary  1  9/167 (5.39%)  13
sleep apnea  1  1/167 (0.60%)  1
Skin and subcutaneous tissue disorders   
Erosion  1  1/167 (0.60%)  1
Post-surgical wound discomfort  1  1/167 (0.60%)  1
Hematoma - Pocket (<=30 days post-implant)  1  4/167 (2.40%)  4
Integumentary  1  1/167 (0.60%)  1
Vascular disorders   
Hypotension  1  1/167 (0.60%)  1
Hypertension  1  1/167 (0.60%)  1
Coronary Artery Disease  1  2/167 (1.20%)  2
Coronary artery disease  1  1/167 (0.60%)  1
Peripheral vascular disease  1  3/167 (1.80%)  4
Intermittent claudication  1  1/167 (0.60%)  1
Cerebrovascular accident (CVA)  1  6/167 (3.59%)  6
Pulmonary embolism (PE)  1  1/167 (0.60%)  1
Intracardiac thrombus  1  1/167 (0.60%)  1
1
Term from vocabulary, BSC internal coding
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
RELIANCE 4-FRONT™ Passive Fixation
Affected / at Risk (%) # Events
Total   55/167 (32.93%)    
Blood and lymphatic system disorders   
Hematological  1  1/167 (0.60%)  1
Cardiac disorders   
Inappropriate tachy therapy - SVT  1  4/167 (2.40%)  5
Inappropriate tachy therapy - Other  1  1/167 (0.60%)  1
Inadvertent VT/VF  1  2/167 (1.20%)  2
Elevated threshold - RA  1  1/167 (0.60%)  1
Elevated threshold - RV  1  1/167 (0.60%)  1
Ventricular fibrillation (VF)  1  2/167 (1.20%)  2
Ventricular tachycardia (VT)  1  1/167 (0.60%)  1
Atrial fibrillation (AF)  1  4/167 (2.40%)  5
Other SVT (AVRT, AVNRT, EAT etc.)  1  3/167 (1.80%)  3
Syncope - Heart failure  1  1/167 (0.60%)  1
Chest pain - Heart failure  1  1/167 (0.60%)  1
Dyspnea - Heart failure  1  7/167 (4.19%)  8
Multiple heart failure symptoms  1  1/167 (0.60%)  1
Hypertension - Heart failure  1  1/167 (0.60%)  1
Chest pain - Ischemic  1  1/167 (0.60%)  1
Chest pain - Other  1  7/167 (4.19%)  7
Palpitations  1  3/167 (1.80%)  3
Endocrine disorders   
Endocrine  1  2/167 (1.20%)  2
Gastrointestinal disorders   
Gastrointestinal  1  5/167 (2.99%)  10
General disorders   
Not yet classified  1  3/167 (1.80%)  4
Fatigue  1  1/167 (0.60%)  1
Physical trauma  1  6/167 (3.59%)  6
Head, eyes, ears, nose, throat (HEENT)  1  10/167 (5.99%)  12
Cancer  1  2/167 (1.20%)  4
medication side effect  1  1/167 (0.60%)  1
Injury, poisoning and procedural complications   
Hematoma - Pocket (<=30 days post-implant)  1  2/167 (1.20%)  2
Musculoskeletal and connective tissue disorders   
Musculoskeletal  1  6/167 (3.59%)  12
Psychiatric disorders   
Psychological  1  1/167 (0.60%)  1
Renal and urinary disorders   
Genitourinary  1  4/167 (2.40%)  5
Renal  1  1/167 (0.60%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary  1  2/167 (1.20%)  2
Skin and subcutaneous tissue disorders   
Integumentary  1  3/167 (1.80%)  5
pain in device pocket  1  1/167 (0.60%)  1
Surgical and medical procedures   
Post-surgical wound discomfort  1  1/167 (0.60%)  1
Hemorrhage  1  1/167 (0.60%)  1
Vascular disorders   
Coronary venous dissection  1  1/167 (0.60%)  1
1
Term from vocabulary, BSC internal coding
Indicates events were collected by systematic assessment
Sample size is rather small and the power of the study is only 80%
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.
Results Point of Contact
Name/Title: Anneleen Viville
Organization: Boston Scientific
Phone: 0032479983495
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01856491     History of Changes
Other Study ID Numbers: C1868
First Submitted: May 15, 2013
First Posted: May 17, 2013
Results First Submitted: July 27, 2017
Results First Posted: November 20, 2017
Last Update Posted: April 30, 2019