Sudden Cardiac DeathNOTICE-HFNCT01227785
Next Generation INCEPTA Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT-D) Field Following Study
An observational study of Sudden Cardiac Death and Heart Failure, run by Guidant Corporation at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Cardiac Death, Heart Failure
- What is being tested?
- INCEPTA ICD or CRT-D
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to Dec 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients should be selected from the investigator's general population and be indicated for an ICD or CRT-D implantation.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Next Generation INCEPTA ICD and CRT-D Field Following Study: Respiratory Rate Trend Evaluation in Heart Failure (HF) Patients
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.
Read the 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.
- Conditions
- Sudden Cardiac Death, Heart Failure
- Being tested
- INCEPTA ICD or CRT-D
- Medical subject headings
- Death, Sudden, Cardiac, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCEPTA ICD or CRT-DDevice
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: INCEPTA ICD or CRT-D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1month
Clinical Performance at Implant for LV Pacing Threshold
LV pacing threshold results were reported for CRT-D patients at implant.
Measured: implant
Clinical Performance at Pre-discharge for LV Pacing Threshold
LV pacing threshold results were reported at pre-discharge for CRT-D patients.
Measured: 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.
Measured: 1-month
Clinical Performance at Implant for RV Pacing Threshold
RV pacing threshold results were reported at implant
Measured: implant
Clinical Performance at Pre-discharge for RV Pacing Threshold
RV pacing threshold results were reported at pre-discharge
Measured: pre-discharge
Clinical Performance at 1-month for RV Pacing Threshold
RV pacing threshold results were reported at 1-month post-implant
Measured: 1-month
Clinical Performance at Implant for RA Pacing Threshold
RA pacing threshold results were reported for implant
Measured: implant
Clinical Performance at Pre-discharge for RA Pacing Threshold
RA pacing threshold results were reported at pre-discharge
Measured: pre-discharge
Clinical Performance at 1-month for RA Pacing Threshold
RA pacing threshold results were reported at 1-month post-implant
Measured: 1-month
Clinical Performance at Implant LV Pacing Impedance for CRT-D.
LV pacing impedance results at implant were measured in CRT-D.
Measured: implant
Clinical Performance at Pre-discharge for LV Pacing Impedance for CRT-D.
LV pacing impedance results were reported for pre-discharge visit
Measured: 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
Measured: 1-month
Clinical Performance at Implant for RV Pacing Impedance
RV pacing impedance results were reported at implant
Measured: implant
Clinical Performance at Pre-discharge for RV Pacing Impedance
RV pacing impedance results were reported for pre-discharge
Measured: pre-discharge
Clinical Performance at 1-month for RV Pacing Impedance
RV pacing impedance results were reported at 1-month post-implant
Measured: 1-month
Clinical Performance at Implant for RA Pacing Impedance
RA pacing impedance results were reported at implant
Measured: implant
Clinical Performance at Pre-discharge for RA Pacing Impedance
RA pacing impedance results were reported at pre-discharge
Measured: pre-discharge
Clinical Performance at 1-month for RA Pacing Impedance
RA pacing impedance results were reported at 1-month post-implant
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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).
Measured: Results were captured from implant time window to the first event for patients with HFE, up to an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guidant Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227785
- Sponsor's protocol ID
- NOTICE-HF 0410
- Acronym
- NOTICE-HF
- Status last verified
- Apr 2014
- First submitted
- 22 Oct 2010
- Last updated
- 25 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next Generation INCEPTA ICD and CRT-D Field Following Study: Respiratory Rate Trend Evaluation in Heart Failure (HF) Patients
- ClinicalTrials.gov ID
- NCT01227785
- Acronym / sponsor ID
- NOTICE-HF / NOTICE-HF 0410
- Conditions
- Sudden Cardiac Death, Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Guidant CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Oct 2010 (estimated)
- Results
- Posted 8 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INCEPTA ICD and CRT-D | – | Device: INCEPTA ICD or CRT-DICD 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients should be selected from the investigator's general population and be indicated for an ICD or CRT-D implantation.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCEPTA ICD or CRT-D | Device | INCEPTA ICD and CRT-D |
Primary outcome
Clinical Performance for Left Ventricular (LV) Sensing Amplitude at Implant for CRT-D Patients
Time frame: implant
Left Ventricular (LV) Sensed Amplitude results were reported at implant for CRT-D patients.
Clinical Performance at Pre-discharge for LV Sensing Amplitude for CRT-D Patients
Time frame: pre-discharge
Left Ventricular (LV) Sensed Amplitude results were reported pre-discharge for CRT-D patients.
Clinical Performance at1-month for Left Ventricular (LV) Sensing Amplitude for CRT-D Patients
Time frame: 1-month
LV Sensed Amplitude results were reported at 1-month post-implant for CRT-D patients.
Clinical Performance at Implant for Right Atrium (RA) Sensing Amplitude
Time frame: implant
RA Sensed Amplitude results were reported for implant for CRT-D and ICD patients
Clinical Performance at Pre-discharge for RA Sensing Amplitude
Time frame: pre-discharge
RA Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients
Clinical Performance at1-month for RA Sensing Amplitude
Time frame: 1-month
RA Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients
Clinical Performance at Implant for Right Ventricle (RV) Sensing Amplitude
Time frame: implant
RV Sensed Amplitude results were reported at implant for CRT-D and ICD patients
Clinical Performance at Pre-discharge for Right Ventricle (RV) Sensing Amplitude
Time frame: pre-discharge
RV Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients
Clinical Performance at1-month for Right Ventricle (RV) Sensing Amplitude
Time frame: 1month
RV Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients
Clinical Performance at Implant for LV Pacing Threshold
Time frame: implant
LV pacing threshold results were reported for CRT-D patients at implant.
Clinical Performance at Pre-discharge for LV Pacing Threshold
Time frame: pre-discharge
LV pacing threshold results were reported at pre-discharge for CRT-D patients.
Clinical Performance at1-month for LV Pacing Threshold
Time frame: 1-month
LV pacing threshold results were reported at 1-month post-implant for CRT-D patients.
Clinical Performance at Implant for RV Pacing Threshold
Time frame: implant
RV pacing threshold results were reported at implant
Clinical Performance at Pre-discharge for RV Pacing Threshold
Time frame: pre-discharge
RV pacing threshold results were reported at pre-discharge
Clinical Performance at 1-month for RV Pacing Threshold
Time frame: 1-month
RV pacing threshold results were reported at 1-month post-implant
Clinical Performance at Implant for RA Pacing Threshold
Time frame: implant
RA pacing threshold results were reported for implant
Clinical Performance at Pre-discharge for RA Pacing Threshold
Time frame: pre-discharge
RA pacing threshold results were reported at pre-discharge
Clinical Performance at 1-month for RA Pacing Threshold
Time frame: 1-month
RA pacing threshold results were reported at 1-month post-implant
Clinical Performance at Implant LV Pacing Impedance for CRT-D.
Time frame: implant
LV pacing impedance results at implant were measured in CRT-D.
Clinical Performance at Pre-discharge for LV Pacing Impedance for CRT-D.
Time frame: pre-discharge
LV pacing impedance results were reported for pre-discharge visit
Clinical Performance at 1-month for LV Pacing Impedance for CRT-D.
Time frame: 1-month
LV pacing impedance results were reported at 1-month post-implant
Clinical Performance at Implant for RV Pacing Impedance
Time frame: implant
RV pacing impedance results were reported at implant
Clinical Performance at Pre-discharge for RV Pacing Impedance
Time frame: pre-discharge
RV pacing impedance results were reported for pre-discharge
Clinical Performance at 1-month for RV Pacing Impedance
Time frame: 1-month
RV pacing impedance results were reported at 1-month post-implant
Clinical Performance at Implant for RA Pacing Impedance
Time frame: implant
RA pacing impedance results were reported at implant
Clinical Performance at Pre-discharge for RA Pacing Impedance
Time frame: pre-discharge
RA pacing impedance results were reported at pre-discharge
Clinical Performance at 1-month for RA Pacing Impedance
Time frame: 1-month
RA pacing impedance results were reported at 1-month post-implant
Product Experiences Reported by the Site for All Patients for Study Duration
Time frame: Overall study results
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.
Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episode Successful Conversion Rates at Implant
Time frame: 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.
Induced VT/VF Episode Successful Conversion Rates at 1-month
Time frame: 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.
Induced VT/VF Episode Successful Conversion Rates at 3-months
Time frame: 3-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.
Induced Episode Detection Times at Implant
Time frame: 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.
Induced Episode Detection Times at 1-month
Time frame: 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.
Induced Episode Detection Times at 3 Months
Time frame: 3-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.
Spontaneous Episode Conversion Success Rate at 3 Months
Time frame: 3-month
Of the total patients that experienced a spontaneous episode, the % of patients with a spontaneous rhythm conversion that was successful was determined.
Wanded Telemetry Issues at Pre-discharge Follow-up
Time frame: Pre-Discharge visit occurred after implant but prior to 1 month follow-up visit
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.
1 secondary outcome
Evaluate the Daily Median Respiratory Rate Trend in Patients Who Experience a HF-event Compared to Patients Who do Not Experience a HF-event.
Time frame: Results were captured from implant time window to the first event for patients with HFE, up to an average of 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Death and Heart Failure, run by Guidant Corporation at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Performance for Left Ventricular (LV) Sensing Amplitude at Implant for CRT-D Patients (time frame: implant). The study lists 36 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2014.