Heart FailurePhase 4NCT00170313
CORE: Study to Evaluate the Conducted AF-Response-Algorithm in Patients Suffering From Heart Failure and Atrial Fibrillation
A Phase 4 study testing Conducted AF-Response Algorithm (CAFR) On and Conducted AF-Response Algorithm (CAFR) Off in people with Heart Failure and Sudden Cardiac Death, run by Medtronic Cardiac Rhythm and Heart Failure at 7 sites in Germany.
Trial summary
The Medtronic InSync III Marquis Cardiac Resynchronization Therapy Defibrillator (CRT-D)-System (implantable cardioverter-defibrillator with biventricular stimulation for cardiac resynchronization) is equipped with the "Conducted-Atrial Fibrillation (AF)-Response-Algorithm (CAFR)". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Sudden Cardiac Death, Atrial Fibrillation
- What is being tested?
- Conducted AF-Response Algorithm (CAFR) On and Conducted AF-Response Algorithm (CAFR) Off
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesGermany
- Study dates
- Dec 2003to Jan 2007
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Implant of a Medtronic InSync III Marquis (7279) or later system with Conducted AF-Response
Who cannot join
- Medical reasons that are adverse to participation in the study and compliance by the patient
- Patients who are enrolled in another study or plan to be enrolled into another study
- Pregnant patients or patients who are possibly pregnant due to an unreliable form of contraception
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Universitätsklinikum Aachen
Aachen, 52066
Berufsgenossenschaftliche Kliniken Bergmannsheil
Bochum, 44789
Evangelisches und Johanniter Klinikum Duisburg / Dinslaken / Oberhausen GmbH
Duisburg, 47137
Klinikum der Justus-Liebig-Universität
Giessen, 35385
Medizinische Hochschule Hannover
Hanover, 30625
Marien-Hospital Herne
Herne, 44625
Klinikum Siegburg Rhein-Sieg GmbH Krankenhaus und Herzzentrum Siegburg
Siegburg, 53721
About this study
Official title: Conducted AF-Response Study (Study to Evaluate the Conducted AF-Response-Algorithm in Patients Suffering From Heart Failure and Atrial Fibrillation Treated With InSync III Marquis)
The Medtronic InSync III Marquis Cardiac Resynchronization Therapy Defibrillator (CRT-D)-System (implantable cardioverter-defibrillator with biventricular stimulation for cardiac resynchronization) is equipped with the "Conducted-Atrial Fibrillation (AF)-Response-Algorithm (CAFR)". This algorithm is designed to maximize biventricular stimulation and thus the amount of cardiac resynchronization when atrial fibrillation occurs. The goal of the study is the evaluation of the effect of the CAFR in CRT-patients suffering from atrial fibrillation by quantification of the increase of biventricular pacing during atrial fibrillation caused by CAFR as well as the influence of the CAFR on the ventricular heart rate.
- Conditions
- Heart Failure, Sudden Cardiac Death, Atrial Fibrillation
- Being tested
- Conducted AF-Response Algorithm (CAFR) On, Conducted AF-Response Algorithm (CAFR) Off
- Keywords
- Heart Failure, Primary Prevention of Sudden Cardiac Death, Secondary Prevention of Sudden Cardiac Death, Cardiac Desynchronization, CRT-D, Cardiac Dyssynchrony
- Medical subject headings
- Heart Failure, Death, Sudden, Cardiac, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conducted AF-Response Algorithm (CAFR) OnDevice
Algorithm will be enabled.
Conducted AF-Response Algorithm (CAFR) OffDevice
Algorithm will be disabled.
| Study group | Role | What they receive |
|---|---|---|
| Conducted AF-Response Algorithm (CAFR) On | Experimental | CAFR: On
* Level medium
* Max. Rate: 110ppm VSR: Off Receives: Device: Conducted AF-Response Algorithm (CAFR) On |
| Conducted AF-Response Algorithm (CAFR) Off | Active comparator | CAFR: Off VSR: Off Receives: Device: Conducted AF-Response Algorithm (CAFR) Off |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of biventricular pacing in ON-group compared to OFF-group
Measured: 1 month post-implant to 12 months post-implant
Secondary outcomes (11)
Influence of the conducted AF response algorithm on the ventricular heart rate during atrial fibrillation
Measured: 1 month post-implant to 12 months post-implant
Amount of patients who will be free from AF during the study
Measured: Implant to 12 months post-implant
Amount of hospitalizations due to heart failure (amount and duration in days)
Measured: Implant to 12 months post-implant
Occurrence and evaluation of rhythm disturbances: atrial arrhythmias (atrial tachyarrhythmia [AT]/AF episodes [h/day])
Measured: Implant to 12 months post-implant
Occurrence and evaluation of rhythm disturbances: ventricular arrhythmias
Measured: Implant to 12 months post-implant
Characterization of the heart failure (HF)-patient population by means of: echocardiography [left ventricular ejection fraction (LVEF [%])
Measured: Implant to 12 months post-implant
Characterization of the heart failure (HF)-patient population by means of: left ventricular end diastolic diameter (LVEDD [mm])
Measured: Implant to 12 months post-implant
Characterization of the heart failure (HF)-patient population by means of: left ventricular end systolic diameter (LVESD [mm])
Measured: Implant to 12 months post-implant
Characterization of the heart failure (HF)-patient population by means of: left atrial end diastolic diameter (LAEDD [mm])]
Measured: Implant to 12 months post-implant
Characterization of the heart failure (HF)-patient population by means of: New York Heart Association (NYHA) classification
Measured: Implant to 12 months post-implant
Characterization of the heart failure (HF)-patient population by means of: 6-minute walk test
Measured: Implant to 12 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startDec 2003
- Study completionJan 2007
Why it stopped: Ventricular rate during AF in CRT-patients much lower than expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Christian Perings, MD, Principal investigator, Marien Hospital Herne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170313
- Sponsor's protocol ID
- CEN_G_CA_6
- Status last verified
- Jan 2017
- First submitted
- 13 Sep 2005
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conducted AF-Response Study (Study to Evaluate the Conducted AF-Response-Algorithm in Patients Suffering From Heart Failure and Atrial Fibrillation Treated With InSync III Marquis)
- ClinicalTrials.gov ID
- NCT00170313
- Acronym / sponsor ID
- CEN_G_CA_6
- Conditions
- Heart Failure, Sudden Cardiac Death, Atrial Fibrillation
- Keywords
- Heart Failure, Primary Prevention of Sudden Cardiac Death, Secondary Prevention of Sudden Cardiac Death, Cardiac Desynchronization, CRT-D, Cardiac Dyssynchrony
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Ventricular rate during AF in CRT-patients much lower than expected
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- Dec 2003
- Study completion
- Jan 2007 (actual)
- First posted
- 15 Sep 2005 (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.
The Medtronic InSync III Marquis Cardiac Resynchronization Therapy Defibrillator (CRT-D)-System (implantable cardioverter-defibrillator with biventricular stimulation for cardiac resynchronization) is equipped with the "Conducted-Atrial Fibrillation (AF)-Response-Algorithm (CAFR)". This algorithm is designed to maximize biventricular stimulation and thus the amount of cardiac resynchronization when atrial fibrillation occurs. The goal of the study is the evaluation of the effect of the CAFR in CRT-patients suffering from atrial fibrillation by quantification of the increase of biventricular pacing during atrial fibrillation caused by CAFR as well as the influence of the CAFR on the ventricular heart rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conducted AF-Response Algorithm (CAFR) On | Experimental | Device: Conducted AF-Response Algorithm (CAFR) OnCAFR: On * Level medium * Max. Rate: 110ppm VSR: Off |
| Conducted AF-Response Algorithm (CAFR) Off | Active comparator | Device: Conducted AF-Response Algorithm (CAFR) OffCAFR: Off VSR: Off |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Implant of a Medtronic InSync III Marquis (7279) or later system with Conducted AF-Response
Key exclusion criteria (3 listed)
- Medical reasons that are adverse to participation in the study and compliance by the patient
- Patients who are enrolled in another study or plan to be enrolled into another study
- Pregnant patients or patients who are possibly pregnant due to an unreliable form of contraception
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 |
|---|---|---|
| Conducted AF-Response Algorithm (CAFR) OnAlgorithm will be enabled. | Device | Conducted AF-Response Algorithm (CAFR) On |
| Conducted AF-Response Algorithm (CAFR) OffAlgorithm will be disabled. | Device | Conducted AF-Response Algorithm (CAFR) Off |
Primary outcome
Amount of biventricular pacing in ON-group compared to OFF-group
Time frame: 1 month post-implant to 12 months post-implant
11 secondary outcomes
Influence of the conducted AF response algorithm on the ventricular heart rate during atrial fibrillation
Time frame: 1 month post-implant to 12 months post-implant
Amount of patients who will be free from AF during the study
Time frame: Implant to 12 months post-implant
Amount of hospitalizations due to heart failure (amount and duration in days)
Time frame: Implant to 12 months post-implant
Occurrence and evaluation of rhythm disturbances: atrial arrhythmias (atrial tachyarrhythmia [AT]/AF episodes [h/day])
Time frame: Implant to 12 months post-implant
Occurrence and evaluation of rhythm disturbances: ventricular arrhythmias
Time frame: Implant to 12 months post-implant
Characterization of the heart failure (HF)-patient population by means of: echocardiography [left ventricular ejection fraction (LVEF [%])
Time frame: Implant to 12 months post-implant
Characterization of the heart failure (HF)-patient population by means of: left ventricular end diastolic diameter (LVEDD [mm])
Time frame: Implant to 12 months post-implant
Characterization of the heart failure (HF)-patient population by means of: left ventricular end systolic diameter (LVESD [mm])
Time frame: Implant to 12 months post-implant
Characterization of the heart failure (HF)-patient population by means of: left atrial end diastolic diameter (LAEDD [mm])]
Time frame: Implant to 12 months post-implant
Characterization of the heart failure (HF)-patient population by means of: New York Heart Association (NYHA) classification
Time frame: Implant to 12 months post-implant
Characterization of the heart failure (HF)-patient population by means of: 6-minute walk test
Time frame: Implant to 12 months post-implant
Results and safety
The study was stopped early (reason given: Ventricular rate during AF in CRT-patients much lower than expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Christian Perings, MD principal investigator
Marien Hospital Herne
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conducted AF-Response Algorithm (CAFR) On and Conducted AF-Response Algorithm (CAFR) Off in people with Heart Failure and Sudden Cardiac Death, run by Medtronic Cardiac Rhythm and Heart Failure at 7 sites 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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Ventricular rate during AF in CRT-patients much lower than expected). 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.
What does the primary outcome measure?
Amount of biventricular pacing in ON-group compared to OFF-group (time frame: 1 month post-implant to 12 months post-implant). 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 3 Jul 2025.