Next Generation INCEPTA Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT-D) Field Following Study (NOTICE-HF)

Next Generation INCEPTA ICD and CRT-D Field Following Study: Respiratory Rate Trend Evaluation in Heart Failure (HF) Patients

This study has 2 purposes:

The first purpose of the study is to test a new family of Boston Scientific Implantable Cardioverter Defibrillators ("ICDs") and cardiac resynchronization therapy ICDs ("CRT-Ds") and show how well these new devices work in patients. This new family is called the INCEPTA ICD and the INCEPTA CRT-D.

The second purpose of the study is to collect data from a feature that monitors breathing. It is called the Respiratory Rate Trend (RRT). These data will help to better understand how changes in breathing relate to changes in clinical conditions.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Sudden Cardiac Death
• Intervention / Treatment: Device: INCEPTA ICD or CRT-D

Detailed Description

Study Purpose

Study purpose I:

To evaluate and document appropriate clinical performance of the INCEPTA (DR and VR) implantable cardioverter defibrillator (ICD) system and the INCEPTA cardiac resynchronization therapy ICD (CRT-D) system and associated application software.

Study purpose II:

Demonstrate the clinical relevance of chronic ambulatory daily median Respiratory Rate Trend (RRT) in HF patients

Study Device

• INCEPTA (DR and VR) implantable cardioverter defibrillator (ICD) system (Models F160, F161, F162, F163)
• INCEPTA cardiac resynchronization therapy ICD (CRT-D) system (Models P162, P163, P165)

Indication ICD / CRT-D Indication according to standard clinical practice

Study Objectives

The study has two primary objectives, linked to the respective study purposes:

For purpose I:

The objective is to collect data on the clinical performance of the INCEPTA ICD and CRT-D devices during standard clinical use at implant, pre-discharge and at a 1-month post-implant. Clinical performance included analysis of pacing thresholds, pacing impedance, sensing thresholds, number of successfully converted VT/VF episodes, induced episodes detection times, spontaneous episodes, wanded telemetry, adverse events (AEs) and product experiences.

For purpose II:

The objective is to show that daily median respiratory rate increases more in patients who experience an HF-event (Group 1) than in patients who do not experience an HF-event (Group 2).

This is a prospective, multi-centre, field following study.

Up to 35 study centers in the International geography will enrol 120 patients.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Deutsches Herzzentrum Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients should be selected from the investigator's general population and be indicated for an ICD or CRT-D implantation.

Description

Inclusion Criteria:

• Patients who are willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical study;
• Patients whose age is 18 or above, or of legal age to give informed consent specific to national law

• Patients indicated for an ICD according to normal clinical practice (for those patients receiving an INCEPTA ICD).

  -As soon as 20 ICD patients are included in the study for purpose I, only NYHA Class III patients will be allowed in the study.

• New York Heart Association (NYHA) Class III patients indicated for a CRT-D according to normal clinical practice (for those patients receiving an INCEPTA CRT-D).

Exclusion Criteria:

• Women of childbearing potential who are or might be pregnant at the time of the study (method of assessment upon physician's discretion)
• Enrolled in any other concurrent study.
• Inability or refusal to comply with the follow-up schedule
• Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days
• Patients prescribed to positive airway pressure therapy
• A life expectancy of less than 1 year, per physician discretion
• Patient in NYHA Class IV during the last 4 weeks

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
INCEPTA ICD and CRT-D; ICD and CRT-D indicated patients were included in the study. Overall patient population, CRT-D or ICD populations, and patients experiencing or not experiencing a protocol-defined heart failure event were included (dependent on outcomes measured).	Device: INCEPTA ICD or CRT-D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Performance for Left Ventricular (LV) Sensing Amplitude at Implant for CRT-D Patients	Left Ventricular (LV) Sensed Amplitude results were reported at implant for CRT-D patients.	implant
Clinical Performance at Pre-discharge for LV Sensing Amplitude for CRT-D Patients	Left Ventricular (LV) Sensed Amplitude results were reported pre-discharge for CRT-D patients.	pre-discharge
Clinical Performance at1-month for Left Ventricular (LV) Sensing Amplitude for CRT-D Patients	LV Sensed Amplitude results were reported at 1-month post-implant for CRT-D patients.	1-month
Clinical Performance at Implant for Right Atrium (RA) Sensing Amplitude	RA Sensed Amplitude results were reported for implant for CRT-D and ICD patients	implant
Clinical Performance at Pre-discharge for RA Sensing Amplitude	RA Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients	pre-discharge
Clinical Performance at1-month for RA Sensing Amplitude	RA Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients	1-month
Clinical Performance at Implant for Right Ventricle (RV) Sensing Amplitude	RV Sensed Amplitude results were reported at implant for CRT-D and ICD patients	implant
Clinical Performance at Pre-discharge for Right Ventricle (RV) Sensing Amplitude	RV Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients	pre-discharge
Clinical Performance at1-month for Right Ventricle (RV) Sensing Amplitude	RV Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients	1month
Clinical Performance at Implant for LV Pacing Threshold	LV pacing threshold results were reported for CRT-D patients at implant.	implant
Clinical Performance at Pre-discharge for LV Pacing Threshold	LV pacing threshold results were reported at pre-discharge for CRT-D patients.	pre-discharge
Clinical Performance at1-month for LV Pacing Threshold	LV pacing threshold results were reported at 1-month post-implant for CRT-D patients.	1-month
Clinical Performance at Implant for RV Pacing Threshold	RV pacing threshold results were reported at implant	implant
Clinical Performance at Pre-discharge for RV Pacing Threshold	RV pacing threshold results were reported at pre-discharge	pre-discharge
Clinical Performance at 1-month for RV Pacing Threshold	RV pacing threshold results were reported at 1-month post-implant	1-month
Clinical Performance at Implant for RA Pacing Threshold	RA pacing threshold results were reported for implant	implant
Clinical Performance at Pre-discharge for RA Pacing Threshold	RA pacing threshold results were reported at pre-discharge	pre-discharge
Clinical Performance at 1-month for RA Pacing Threshold	RA pacing threshold results were reported at 1-month post-implant	1-month
Clinical Performance at Implant LV Pacing Impedance for CRT-D.	LV pacing impedance results at implant were measured in CRT-D.	implant
Clinical Performance at Pre-discharge for LV Pacing Impedance for CRT-D.	LV pacing impedance results were reported for pre-discharge visit	pre-discharge
Clinical Performance at 1-month for LV Pacing Impedance for CRT-D.	LV pacing impedance results were reported at 1-month post-implant	1-month
Clinical Performance at Implant for RV Pacing Impedance	RV pacing impedance results were reported at implant	implant
Clinical Performance at Pre-discharge for RV Pacing Impedance	RV pacing impedance results were reported for pre-discharge	pre-discharge
Clinical Performance at 1-month for RV Pacing Impedance	RV pacing impedance results were reported at 1-month post-implant	1-month
Clinical Performance at Implant for RA Pacing Impedance	RA pacing impedance results were reported at implant	implant
Clinical Performance at Pre-discharge for RA Pacing Impedance	RA pacing impedance results were reported at pre-discharge	pre-discharge
Clinical Performance at 1-month for RA Pacing Impedance	RA pacing impedance results were reported at 1-month post-implant	1-month
Product Experiences Reported by the Site for All Patients for Study Duration	Product experiences reported may include the shock impedance noise display, problems encountered with the universal serial bus (USB), a program parameter mismatch, reverse mode switches, electrogram (EGM) noise without oversensing, lead connection issues, or customer device feedback.	Overall study results
Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episode Successful Conversion Rates at Implant	The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.	implant
Induced VT/VF Episode Successful Conversion Rates at 1-month	The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.	1-month
Induced VT/VF Episode Successful Conversion Rates at 3-months	The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.	3-month
Induced Episode Detection Times at Implant	The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.	implant
Induced Episode Detection Times at 1-month	The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.	1-month
Induced Episode Detection Times at 3 Months	The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.	3-month
Spontaneous Episode Conversion Success Rate at 3 Months	Of the total patients that experienced a spontaneous episode, the % of patients with a spontaneous rhythm conversion that was successful was determined.	3-month
Wanded Telemetry Issues at Pre-discharge Follow-up	The Investigators completed a questionnaire based on the performance of the wanded telemetry during device interrogations at pre-discharge follow-up. The number of problems reported were counted from the entire study cohort.	Pre-Discharge visit occurred after implant but prior to 1 month follow-up visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the Daily Median Respiratory Rate Trend in Patients Who Experience a HF-event Compared to Patients Who do Not Experience a HF-event.	A comparison of the change in respiratory rate trend over time was made between patients who experienced a protocol-defined HF event (HFE) (Group1: Patients with a HFE) and patients who did not experience a protocol-defined heart failure event (Group 2: Patients without a HFE). Only patients with at least 3 valid daily respiratory rate values (60%) out of each 5-day window were evaluated. The objective was to show that daily median respiratory rate increases more in patients who experience a HFE (Group 1) than in patients who do not experience an HFE (Group 2). A comparison between patients who experience a HFE (Group 1) and patients who do not experience a HFE (Group 2). Two average daily median respiratory rates were done per patient: 60 to 56 days before an index time and 11 to 7 days before the same index time; the difference between these two averaged daily median respiratory rates was done. Index time=day of the first HFE (Group 1) and day of 6-month visit (Group 2).	Results were captured from implant time window to the first event for patients with HFE, up to an average of 9 months

Collaborators and Investigators

• Sponsor: Guidant Corporation
• Collaborators: University of Rochester

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: October 22, 2010
• First Submitted That Met QC Criteria: October 22, 2010
• First Posted (Estimate): October 25, 2010

Study Record Updates

• Last Update Posted (Estimate): April 25, 2014
• Last Update Submitted That Met QC Criteria: April 9, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Heart Arrest; Heart Failure; Death; Death, Sudden, Cardiac
• Other Study ID Numbers: NOTICE-HF 0410