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

NCT01227785 | Completed Results

• 1 other identifier: NOTICE-HF 0410
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Sudden Cardiac Death; Heart Failure

Outcome Measures

Primary Outcomes (36)

• 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 Outcomes (1)

• Evaluate the Daily Median Respiratory Rate Trend in Patients Who Experience a HF-event Compared to Patients Who do Not Experience a HF-event.

  Results were captured from implant time window to the first event for patients with HFE, up to an average of 9 months

Study Arms (1)

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

Interventions

INCEPTA ICD or CRT-D DEVICE

INCEPTA ICD and CRT-D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Guidant Corporation: lead
• University of Rochester: collaborator

Study Sites (1)

Deutsches Herzzentrum Berlin

Berlin, State of Berlin, Germany

Location

MeSH Terms

Conditions

Death, Sudden, Cardiac; Heart Failure

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Paji Vitoff, Senior Clinical Manager
• Organization: Guidant, a Boston Scientific Company

paji.vitoff@bsci.com

651-582-5415

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: October 25, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 25, 2014
• Results First Posted: April 8, 2014

Record last verified: 2014-04

Locations

DE (1)