Congestive Heart Failure (CHF)NCT00528320
Clinical Evaluation of Cardiac Resynchronization Therapy (CRT) Using the Ovatio CRT Implantable Cardioverter-defibrillator (ICD) System
A study testing Ovatio CRT in people with Congestive Heart Failure (CHF), run by ELA Medical, Inc..
Trial summary
This study provides a continued access registry for cardiac resynchronization therapy with defibrillation (CRT-D), which helps to resynchronize (coordinate) the rhythm of the heart by helping the left ventricle contract (pump blood) more uniformly, in patients with severe heart failure (New York Heart Association… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure (CHF)
- What is being tested?
- Ovatio CRT
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Who may be able to join
- Accepted indication for ICD implant
- Severe heart failure (NYHA Class III or IV) at the time of enrollment
- May have pre-existing ICD, provided subject is on stable, optimal medical regime
- Sinus rhythm with spontaneous QRS duration greater than or equal to 150 ms, or a QRS duration greater than or equal to 130 ms with an inter-ventricular mechanical delay (IVMD) greater than or equal to 40 ms
- Left-ventricular ejection fraction (LVEF) of 35% or less
Who cannot join
- Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing
- Any contraindication for ICD therapy
- Currently implanted with a lead positioned in or through the coronary sinus
- Hypertrophic or obstructive cardiomyopathy
- Acute myocarditis
- Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month
Show all 21Show fewer
- Recent or planned cardiac revascularization or coronary angioplasty
- Correctable valvular disease that is the primary cause of heart failure
- Mechanical tricuspid valve
- Chronic atrial arrhythmia or cardioversion for atrial fibrillation within the past month, or paroxysmal atrial fibrillation requiring new pharmacologic therapy within the past month
- Systolic blood pressure consistently above 170 mmHg or consistently below 80 mmHg
- Supine resting heart rate exceeding 100 bpm
- Receiving continuous IV infusion of positive inotropic therapy or intermittent therapy (IV infusion) more than twice per week
- Heart transplant recipient
- Primary pulmonary disease of a severity that might limit the patient's ability to perform a treadmill test
- Serum creatinine above 3.0 mg/dL
- Serum hepatic functions at or above three times the upper normal limit
- Cerebrovascular event within the previous three months
- Inability to walk or other physical impediments which might prevent the patient from completing a maximum, symptom-limited treadmill test
- Age of less than 18 years
- Pregnancy
About this study
Official title: Clinical Evaluation of Cardiac Resynchronization Therapy With Implantable Cardioverter-defibrillator Therapy
This study provides a continued access registry for cardiac resynchronization therapy with defibrillation (CRT-D), which helps to resynchronize (coordinate) the rhythm of the heart by helping the left ventricle contract (pump blood) more uniformly, in patients with severe heart failure (New York Heart Association [NYHA] Class III or IV).
Quality of life, adverse events and device success will be analyzed and reported.
Read the detailed description
ICDs have been shown to increase life expectancy substantially over various drug regimens in patients with life threatening ventricular arrhythmias. Furthermore, large scale studies of cardiac resynchronization therapy in ICD-indicated heart failure patients have demonstrated improvements in functional capacity and quality of life, without unacceptable increases in morbidity or mortality.
This study provides a continued access registry for cardiac resynchronization therapy with defibrillation (CRT-D), which helps to resynchronize (coordinate) the rhythm of the heart by helping the left ventricle contract (pump blood) more uniformly, in patients with severe heart failure (NYHA Class III or IV).
Quality of life, adverse events and device success will be analyzed and reported.
- Conditions
- Congestive Heart Failure (CHF)
- Being tested
- Ovatio CRT
- Keywords
- Congestive Heart Failure, Heart Failure, Cardiac Resynchronization Therapy, ICD, Implantable Cardioverter-Defibrillator, Defibrillator
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovatio CRTDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart Failure (CHF)Studies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- ELA Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528320
- Sponsor's protocol ID
- ITAC06
- Status last verified
- Nov 2013
- First submitted
- 10 Sep 2007
- Last updated
- 27 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Cardiac Resynchronization Therapy With Implantable Cardioverter-defibrillator Therapy
- ClinicalTrials.gov ID
- NCT00528320
- Acronym / sponsor ID
- ITAC06
- Conditions
- Congestive Heart Failure (CHF)
- Keywords
- Congestive Heart Failure, Heart Failure, Cardiac Resynchronization Therapy, ICD, Implantable Cardioverter-Defibrillator, Defibrillator
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- ELA Medical, Inc.Industry (pharma, biotech, devices)
- First posted
- 12 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study provides a continued access registry for cardiac resynchronization therapy with defibrillation (CRT-D), which helps to resynchronize (coordinate) the rhythm of the heart by helping the left ventricle contract (pump blood) more uniformly, in patients with severe heart failure (New York Heart Association [NYHA] Class III or IV).
Quality of life, adverse events and device success will be analyzed and reported.
Detailed description
ICDs have been shown to increase life expectancy substantially over various drug regimens in patients with life threatening ventricular arrhythmias. Furthermore, large scale studies of cardiac resynchronization therapy in ICD-indicated heart failure patients have demonstrated improvements in functional capacity and quality of life, without unacceptable increases in morbidity or mortality.
This study provides a continued access registry for cardiac resynchronization therapy with defibrillation (CRT-D), which helps to resynchronize (coordinate) the rhythm of the heart by helping the left ventricle contract (pump blood) more uniformly, in patients with severe heart failure (NYHA Class III or IV).
Quality of life, adverse events and device success will be analyzed and reported.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Accepted indication for ICD implant
- Severe heart failure (NYHA Class III or IV) at the time of enrollment
- May have pre-existing ICD, provided subject is on stable, optimal medical regime
- Sinus rhythm with spontaneous QRS duration greater than or equal to 150 ms, or a QRS duration greater than or equal to 130 ms with an inter-ventricular mechanical delay (IVMD) greater than or equal to 40 ms
- Left-ventricular ejection fraction (LVEF) of 35% or less
Key exclusion criteria (21 listed)
- Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing
- Any contraindication for ICD therapy
- Currently implanted with a lead positioned in or through the coronary sinus
- Hypertrophic or obstructive cardiomyopathy
- Acute myocarditis
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 |
|---|---|---|
| Ovatio CRT | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ovatio CRT in people with Congestive Heart Failure (CHF), run by ELA Medical, Inc..
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 21 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: status not confirmed, as of the sponsor's last update on 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
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 27 Nov 2013; AzTrials last refreshed its copy on 6 Nov 2026.