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The purpose of this clinical study is to observe the safety and efficacy of the multi-vector left ventricular (LV) lead in Chinese patients that are indicated for Cardiac Resynchronization Therapy (CRT).
This is a multi-center, non-randomized observational study.
The total duration of the study is expected to be 2.5 years. The clinical study will be conducted in no more than 15 centers in China. Approximately 120 subjects will be enrolled in this study. Subjects will be followed up at 3, 6, 12 months and every 6 months afterwards. All subjects need to be followed for at least 6 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT | Device | The study will include the Quartet™ family of left heart leads or any newer St. Jude Medical quadripolar CRT systems, including CRT-P systems, that China Food and Drug Administration (CFDA) might approve in the future |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With LV Lead-related Serious Adverse Device Effects (SADEs) | The primary safety endpoint is the number of participants with LV lead-related SADEs compared to the total number of analyzed participants. | From implantation to 6 months after implant procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Effective LV Pacing | The effectiveness endpoint is the number of participants with effective LV pacing compared to the total number of analyzed participants. The following must be met to be considered effective LV pacing:
|
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Inclusion Criteria:
Exclusion Criteria:
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A patient meets the current ESC or ACCF/AHA/HRS Class I or Class IIa indications for CRT implant
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| Name | Affiliation | Role |
|---|---|---|
| Clay Cohorn | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | 230001 | China | ||
| The second Affliated hospital Anhui Medical University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm- St. Jude Medical Quartet™ LV Lead Model 1458Q | This post-market study was conducted as required by China FDA to characterize the safety and efficacy of the commercial St. Jude Medical (SJM) Quartet™ Left Ventricular (LV) lead model 1458Q implanted with any commercial SJM Unify Quadra CRT-D device or newer SJM quadripolar system (CRT-D or CRT-P). This is a single arm study. The first subject was enrolled on December 25, 2014 and the last subject was enrolled on March 25, 2016. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 121 patients were recruited at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | This post-market study was conducted as required by China FDA to characterize the safety and efficacy of the commercial SJM Quartet™ LV lead model 1458Q implanted with any commercial SJM Unify Quadra CRT-D device or newer SJM quadripolar system (CRT-D or CRT-P). This is a single arm study. The first subject was enrolled on December 25, 2014 and the last subject was enrolled on March 25, 2016. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Participants With LV Lead-related Serious Adverse Device Effects (SADEs) | The primary safety endpoint is the number of participants with LV lead-related SADEs compared to the total number of analyzed participants. | Only subjects with data available for all evaluation time points (implant, pre-discharge, 3 months and 6 months) were considered evaluable and included in analysis. | Posted | Count of Participants | Participants | From implantation to 6 months after implant procedure. |
|
Safety surveillance of subjects started at enrollment and continued for at least 6 months post-enrollment for all subjects, unless the subject was withdrawn from the study or died prior to the 6-month visit. If a subject was retrospectively enrolled, the investigator reported any adverse events which occurred between the implant and the date of enrollment according to the protocol. Sites continued to collect adverse event data in subjects following the 6-month visit until the study completed.
Clinical sites were required to report the following events to the Sponsor:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm | This post-market study was conducted as required by China FDA to characterize the safety and efficacy of the commercial SJM Quartet™ LV lead model 1458Q implanted with any commercial SJM Unify Quadra CRT-D device or newer SJM quadripolar system (CRT-D or CRT-P). This is a single arm study. The first subject was enrolled on December 25, 2014 and the last subject was enrolled on March 25, 2016. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lead Dislodgement | Product Issues | Systematic Assessment | Two events were lead dislodgments and are adjudicated as related to the Quartet™ 1458Q LV lead, other event are adjudicated as related to Right Ventricular (RV) Lead |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment | One subject developed a pocket infection three days post-implant and was successfully treated with antibiotics. This event was related to PG |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clay Cohorn, Clinical Program Director | Cardiac Rhythm Management, Abbott Medical Devices | +19723098087 | clay.cohorn@abbott.com |
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| 6 months |
| The Number of Participants in Each NYHA Functional Class | This secondary objective is to count the number of participants in each NYHA functional class at 6 months; NYHA classification is determined by a physician and measures the severity of a patient's heart failure by evaluating heart failure symptoms and limitations. Class I patients have mild heart failure symptoms, while patients with Class IV have severe symptoms. | 6 months |
| The Intrinsic QRS Duration of Participants | This secondary objective is to measure the intrinsic QRS duration of participants at 6 months. | 6 months |
| Hefei |
| Anhui |
| 230601 |
| China |
| The second Affiliated hospital of Sun Yat-Sen University | Guangzhou | Guangdong | 510235 | China |
| The second hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | 210008 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| Nanjing First Hospital Affiliated to Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
| Zhejiang Greentown cardiovascular hospital | Hangzhou | Zhejiang | 310000 | China |
| The First Affiliated hospital of Medical College of Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| The second Affiliated hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
| Sir Runrun Shaw Hospital College of Medicine Zhejiang University | Hangzhou | Zhejiang | 310016 | China |
| Fuwai Hospital CAMS&PUMC | Beijing | 100037 | China |
| Rui Jin hospital Shanghai Jiao Tong University School of Medicine | Shanghai | 200025 | China |
| Zhongshan Hospital Fudan University | Shanghai | 200032 | China |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator. | Count of Participants | Participants |
|
| New York Heart Association (NYHA) Class, n (%) | NYHA classification is determined by a physician and measures the severity of a patient's heart failure by evaluating heart failure symptoms and limitations. Class I patients have mild heart failure symptoms, while patients with Class IV have severe symptoms. | Count of Participants | Participants |
|
| Intrinsic QRS Duration | A total of 113 patients had intrinsic QRS duration measured at baseline and are included in the analysis population. | Mean | Standard Deviation | milliseconds (ms) |
|
| Primary Cause of Cardiac Disease, n (%) | A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator | Count of Participants | Participants |
|
| Prior Cardiac Interventions, n (%) | Due to characters limitation for Row "PTCA/Stents/Atherectomy", the acronym "PTCA" stands for percutaneous transluminal coronary angiography. | A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator | Number | participants |
|
| Cardiac Medications, n (%) | A total of 121 subjects were enrolled at 13 sites. However, one subject who was retrospectively enrolled after an existing implant did not meet inclusion criteria and therefore was not included in analyses as the subject was withdrawn by the investigator | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | The Number of Participants With Effective LV Pacing | The effectiveness endpoint is the number of participants with effective LV pacing compared to the total number of analyzed participants. The following must be met to be considered effective LV pacing:
| Only subjects with data available for all evaluation time points (implant, pre-discharge, 3 months and 6 months) were considered evaluable and included in analysis. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | The Number of Participants in Each NYHA Functional Class | This secondary objective is to count the number of participants in each NYHA functional class at 6 months; NYHA classification is determined by a physician and measures the severity of a patient's heart failure by evaluating heart failure symptoms and limitations. Class I patients have mild heart failure symptoms, while patients with Class IV have severe symptoms. | Only subjects with data available for all evaluation time points (implant, pre-discharge, 3 months and 6 months) were considered evaluable and included in analysis. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | The Intrinsic QRS Duration of Participants | This secondary objective is to measure the intrinsic QRS duration of participants at 6 months. | Only subjects with data available for all evaluation time points (implant, pre-discharge, 3 months and 6 months) were considered evaluable and included in the analysis. | Posted | Mean | Standard Deviation | Milliseconds | 6 months |
|
|
|
|
| 3 |
| 120 |
| 11 |
| 120 |
| 2 |
| 120 |
|
| Hematoma/Seroma | Product Issues | Systematic Assessment | subject was diagnosed with pocket hematoma/seroma. This was treated by draining approximately 20ml of clear fluid from the pocket and the administration of prophylactic antibiotics.This event was related to PG |
|
| Inappropriate Shocks | Product Issues | Systematic Assessment | inappropriate shock is the most frequently reported SADE, occurring in 3.3% (4/120) of enrolled subjects and none were due to the Quartet™ 1458Q LV lead. 4 events were related to Pulse Generator (PG). 1event was related to RV lead. |
|
| Infection | Infections and infestations | Systematic Assessment | three events were assessed as a pocket infection,2 events were related to PG ,1event was related to system |
|
| Pneumothorax/Hemothorax | Injury, poisoning and procedural complications | Systematic Assessment | chest x-ray showed that a pneumothorax had developed on the left side. The subject was successfully treated with closed thoracic drainage then discharged. This event was related to procedure |
|
| Rise in Threshold and Exit Block | Product Issues | Systematic Assessment | This event was related to RV Lead |
|
|
| Pneumothorax/Hemothorax | Injury, poisoning and procedural complications | Systematic Assessment | subject complained of breathing-related chest pain in the post-operative setting. A chest x-ray revealed left-sided pleural effusion, which was successfully treated by non-invasive means. This event was related to procedure |
|
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| NYHA Class IV |
|
| NYHA Not Done |
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