Next Generation INCEPTA ICD and CRT-D Field Following Study - Full Text View

Purpose

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.

Condition	Intervention
Sudden Cardiac Death Heart Failure	Device: INCEPTA ICD or CRT-D

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Next Generation INCEPTA ICD and CRT-D Field Following Study: Respiratory Rate Trend Evaluation in Heart Failure Patients

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Guidant Corporation:

Primary Outcome Measures:

The performance of the INCEPTA ICD and CRT-D devices during standard clinical use at implant, pre-discharge and at a 1-month post-implant. [ Time Frame: March2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Show that daily median respiratory rate increases more in patients who experience an HF-event than in patients who do not experience an HF-event. [ Time Frame: Dec2011 ] [ Designated as safety issue: No ]

Enrollment:	120
Study Start Date:	October 2010
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
INCEPTA ICD and CRT-D ICD and CRT-D indicated patients	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 performance of the INCEPTA ICD and CRT-D devices during standard clinical use at implant, pre-discharge and at a 1-month post-implant.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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.
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01227785

Locations

Germany
Deutsches Herzzentrum Berlin
Berlin, Germany

Sponsors and Collaborators

Guidant Corporation

University of Rochester

More Information

No publications provided

Responsible Party:	Guidant Corporation
ClinicalTrials.gov Identifier:	NCT01227785 History of Changes
Other Study ID Numbers:	NOTICE-HF 0410
Study First Received:	October 22, 2010
Last Updated:	August 31, 2012
Health Authority:	Austria: Ethikkommission Czech Republic: Ethics Committee Denmark: Ethics Committee Germany: Ethics Commission Hong Kong: Ethics Committee Hungary: Institutional Ethics Committee Israel: Ethics Commission Netherlands: Medical Ethics Review Committee (METC) Norway: Ethics Committee Portugal: Ethics Committee for Clinical Research Spain: Ethics Committee Sweden: Institutional Review Board United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:

Heart Failure
Death, Sudden, Cardiac
Death
Heart Diseases

Cardiovascular Diseases
Heart Arrest
Death, Sudden
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013

Next Generation INCEPTA ICD and CRT-D Field Following Study (NOTICE-HF)