N/A N=120

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

Sudden Cardiac Death · Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT01227785 ↗

Enrolled (actual)

120

Serious AEs

10.8%

Results posted

Apr 2014

Primary outcome: Primary: Clinical Performance for Left Ventricular (LV) Sensing Amplitude at Implant for CRT-D Patients — 14.4 milli volt (mV)

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: INCEPTA ICD or CRT-D (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Guidant Corporation
Primary completion: Dec 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Performance for Left Ventricular (LV) Sensing Amplitude at Implant for CRT-D Patients	14.4	—
PRIMARY Clinical Performance at Pre-discharge for LV Sensing Amplitude for CRT-D Patients	14.9	—
PRIMARY Clinical Performance at1-month for Left Ventricular (LV) Sensing Amplitude for CRT-D Patients	17.2	—
PRIMARY Clinical Performance at Implant for Right Atrium (RA) Sensing Amplitude	3.8; 3.2	—
PRIMARY Clinical Performance at Pre-discharge for RA Sensing Amplitude	4.1; 3.9	—
PRIMARY Clinical Performance at1-month for RA Sensing Amplitude	4.9; 3.7	—
PRIMARY Clinical Performance at Implant for Right Ventricle (RV) Sensing Amplitude	16.2; 15.8	—
PRIMARY Clinical Performance at Pre-discharge for Right Ventricle (RV) Sensing Amplitude	16.7; 16.9	—
PRIMARY Clinical Performance at1-month for Right Ventricle (RV) Sensing Amplitude	17.9; 17.1	—
PRIMARY Clinical Performance at Implant for LV Pacing Threshold	1.3	—
PRIMARY Clinical Performance at Pre-discharge for LV Pacing Threshold	1.5	—
PRIMARY Clinical Performance at1-month for LV Pacing Threshold	1.3	—
PRIMARY Clinical Performance at Implant for RV Pacing Threshold	0.7; 0.8	—
PRIMARY Clinical Performance at Pre-discharge for RV Pacing Threshold	0.7; 0.8	—
PRIMARY Clinical Performance at 1-month for RV Pacing Threshold	0.9; 1.4	—
PRIMARY Clinical Performance at Implant for RA Pacing Threshold	0.8; 1.0	—
PRIMARY Clinical Performance at Pre-discharge for RA Pacing Threshold	0.8; 0.9	—
PRIMARY Clinical Performance at 1-month for RA Pacing Threshold	1.0; 1.0	—
PRIMARY Clinical Performance at Implant LV Pacing Impedance for CRT-D.	879	—
PRIMARY Clinical Performance at Pre-discharge for LV Pacing Impedance for CRT-D.	777	—
PRIMARY Clinical Performance at 1-month for LV Pacing Impedance for CRT-D.	778	—
PRIMARY Clinical Performance at Implant for RV Pacing Impedance	637; 807	—
PRIMARY Clinical Performance at Pre-discharge for RV Pacing Impedance	604; 686	—
PRIMARY Clinical Performance at 1-month for RV Pacing Impedance	590; 658	—
PRIMARY Clinical Performance at Implant for RA Pacing Impedance	538; 670	—
PRIMARY Clinical Performance at Pre-discharge for RA Pacing Impedance	512; 656	—
PRIMARY Clinical Performance at 1-month for RA Pacing Impedance	534; 655	—
PRIMARY Product Experiences Reported by the Site for All Patients for Study Duration	65	—
PRIMARY Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episode Successful Conversion Rates at Implant	100; 100	—
PRIMARY Induced VT/VF Episode Successful Conversion Rates at 1-month	100; 100	—
PRIMARY Induced VT/VF Episode Successful Conversion Rates at 3-months	100; 100	—
PRIMARY Induced Episode Detection Times at Implant	2.46; 2.40	—
PRIMARY Induced Episode Detection Times at 1-month	2.06; 2.06	—
PRIMARY Induced Episode Detection Times at 3 Months	2.28; 2.29	—
PRIMARY Spontaneous Episode Conversion Success Rate at 3 Months	100; 100	—
PRIMARY Wanded Telemetry Issues at Pre-discharge Follow-up	1	—
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.	-0.30; 0	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01227785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.