Clinical trial NCT01227785: Next Generation INCEPTA Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT-D) Field Following Study
Official title: Next Generation INCEPTA ICD and CRT-D Field Following Study: Respiratory Rate Trend Evaluation in Heart Failure (HF) Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sudden Cardiac Death
Heart Failure
Lead sponsor: Guidant Corporation
Sponsor class: INDUSTRY
Collaborators: name: University of Rochester
First posted: 2010-10-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Performance for Left Ventricular (LV) Sensing Amplitude at Implant for CRT-D Patients
timeFrame: implant
measure: Clinical Performance at Pre-discharge for LV Sensing Amplitude for CRT-D Patients
timeFrame: pre-discharge
measure: Clinical Performance at1-month for Left Ventricular (LV) Sensing Amplitude for CRT-D Patients
timeFrame: 1-month
measure: Clinical Performance at Implant for Right Atrium (RA) Sensing Amplitude
timeFrame: implant
measure: Clinical Performance at Pre-discharge for RA Sensing Amplitude
timeFrame: pre-discharge
measure: Clinical Performance at1-month for RA Sensing Amplitude
timeFrame: 1-month
measure: Clinical Performance at Implant for Right Ventricle (RV) Sensing Amplitude
timeFrame: implant
measure: Clinical Performance at Pre-discharge for Right Ventricle (RV) Sensing Amplitude
timeFrame: pre-discharge
measure: Clinical Performance at1-month for Right Ventricle (RV) Sensing Amplitude
timeFrame: 1month
measure: Clinical Performance at Implant for LV Pacing Threshold
timeFrame: implant
measure: Clinical Performance at Pre-discharge for LV Pacing Threshold
timeFrame: pre-discharge
measure: Clinical Performance at1-month for LV Pacing Threshold
timeFrame: 1-month
measure: Clinical Performance at Implant for RV Pacing Threshold
timeFrame: implant
measure: Clinical Performance at Pre-discharge for RV Pacing Threshold
timeFrame: pre-discharge
measure: Clinical Performance at 1-month for RV Pacing Threshold
timeFrame: 1-month
measure: Clinical Performance at Implant for RA Pacing Threshold
timeFrame: implant
measure: Clinical Performance at Pre-discharge for RA Pacing Threshold
timeFrame: pre-discharge
measure: Clinical Performance at 1-month for RA Pacing Threshold
timeFrame: 1-month
measure: Clinical Performance at Implant LV Pacing Impedance for CRT-D.
timeFrame: implant
measure: Clinical Performance at Pre-discharge for LV Pacing Impedance for CRT-D.
timeFrame: pre-discharge
measure: Clinical Performance at 1-month for LV Pacing Impedance for CRT-D.
timeFrame: 1-month
measure: Clinical Performance at Implant for RV Pacing Impedance
timeFrame: implant
measure: Clinical Performance at Pre-discharge for RV Pacing Impedance
timeFrame: pre-discharge
measure: Clinical Performance at 1-month for RV Pacing Impedance
timeFrame: 1-month
measure: Clinical Performance at Implant for RA Pacing Impedance
timeFrame: implant
measure: Clinical Performance at Pre-discharge for RA Pacing Impedance
timeFrame: pre-discharge
measure: Clinical Performance at 1-month for RA Pacing Impedance
timeFrame: 1-month
measure: Product Experiences Reported by the Site for All Patients for Study Duration
timeFrame: Overall study results
measure: Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episode Successful Conversion Rates at Implant
timeFrame: implant
measure: Induced VT/VF Episode Successful Conversion Rates at 1-month
timeFrame: 1-month
measure: Induced VT/VF Episode Successful Conversion Rates at 3-months
timeFrame: 3-month
measure: Induced Episode Detection Times at Implant
timeFrame: implant
measure: Induced Episode Detection Times at 1-month
timeFrame: 1-month
measure: Induced Episode Detection Times at 3 Months
timeFrame: 3-month
measure: Spontaneous Episode Conversion Success Rate at 3 Months
timeFrame: 3-month
measure: Wanded Telemetry Issues at Pre-discharge Follow-up
timeFrame: Pre-Discharge visit occurred after implant but prior to 1 month follow-up visit
Secondary outcomes:
measure: Evaluate the Daily Median Respiratory Rate Trend in Patients Who Experience a HF-event Compared to Patients Who do Not Experience a HF-event.
timeFrame: Results were captured from implant time window to the first event for patients with HFE, up to an average of 9 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
Study officials:
References: