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

Heart Failure Clinical Trial

— NOTICE-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01227785
• Other study ID #: NOTICE-HF 0410
• Status: Completed
• Phase: N/A
• First received: October 22, 2010
• Last updated: April 9, 2014
• Start date: October 2010
• Est. completion date: December 2011

Study information

• Verified date: April 2014
• Source: Guidant Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionCzech Republic: Ethics CommitteeDenmark: Ethics CommitteeGermany: Ethics CommissionHong Kong: Ethics CommitteeHungary: Institutional Ethics CommitteeIsrael: Ethics CommissionNetherlands: Medical Ethics Review Committee (METC)Norway: Ethics CommitteePortugal: Ethics Committee for Clinical ResearchSpain: Ethics CommitteeSweden: Institutional Review BoardUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Heart Failure
• Sudden Cardiac Death

Intervention

Device:
• INCEPTA ICD or CRT-D

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Guidant Corporation	University of Rochester

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Clinical Performance at Implant for LV Pacing Threshold	LV pacing threshold results were reported for CRT-D patients at implant.	implant	No
Primary	Clinical Performance at Pre-discharge for LV Pacing Threshold	LV pacing threshold results were reported at pre-discharge for CRT-D patients.	pre-discharge	No
Primary	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	No
Primary	Clinical Performance at Implant for RV Pacing Threshold	RV pacing threshold results were reported at implant	implant	No
Primary	Clinical Performance at Pre-discharge for RV Pacing Threshold	RV pacing threshold results were reported at pre-discharge	pre-discharge	No
Primary	Clinical Performance at 1-month for RV Pacing Threshold	RV pacing threshold results were reported at 1-month post-implant	1-month	No
Primary	Clinical Performance at Implant for RA Pacing Threshold	RA pacing threshold results were reported for implant	implant	No
Primary	Clinical Performance at Pre-discharge for RA Pacing Threshold	RA pacing threshold results were reported at pre-discharge	pre-discharge	No
Primary	Clinical Performance at 1-month for RA Pacing Threshold	RA pacing threshold results were reported at 1-month post-implant	1-month	No
Primary	Clinical Performance at Implant LV Pacing Impedance for CRT-D.	LV pacing impedance results at implant were measured in CRT-D.	implant	No
Primary	Clinical Performance at Pre-discharge for LV Pacing Impedance for CRT-D.	LV pacing impedance results were reported for pre-discharge visit	pre-discharge	No
Primary	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	No
Primary	Clinical Performance at Implant for RV Pacing Impedance	RV pacing impedance results were reported at implant	implant	No
Primary	Clinical Performance at Pre-discharge for RV Pacing Impedance	RV pacing impedance results were reported for pre-discharge	pre-discharge	No
Primary	Clinical Performance at 1-month for RV Pacing Impedance	RV pacing impedance results were reported at 1-month post-implant	1-month	No
Primary	Clinical Performance at Implant for RA Pacing Impedance	RA pacing impedance results were reported at implant	implant	No
Primary	Clinical Performance at Pre-discharge for RA Pacing Impedance	RA pacing impedance results were reported at pre-discharge	pre-discharge	No
Primary	Clinical Performance at 1-month for RA Pacing Impedance	RA pacing impedance results were reported at 1-month post-implant	1-month	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No