Heart Failure，CongestiveNCT03187470
Left Ventricular Dyssynchrony in Multipole Pacing
A study testing Different programming of a CRT defibrillator in people with Heart Failure，Congestive, run by Adnan Kastrati, MD at 1 site in Germany.
Trial summary
Left ventricular dyssynchrony will be assessed by echocardiography using different programming of an implantable cardioverter defibrillator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure，Congestive
- What is being tested?
- Different programming of a CRT defibrillator
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2017to 31 May 2018
- Phase
- Interventional
- 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
- Indication for the implantation of a defibrillator with cardiac resynchronisation therapy
Who cannot join
- Cardiac surgery, acute coronary syndrome / myocardial infarction, percutaneous coronary intervention within the past 4 weeks
- Indication for coronary artery revascularisation
- Atrial fibrillation with insufficient rate control
- ASA (American Society of Anesthesiologists) class V or cardiogenic shock
- age <18 years, pregnancy, tutelage
- inability to understand the patient consent for or study refusal
- anticipated insufficient echocardiographic image quality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Multipole Pacing (MPP) on Left Ventricular Dyssynchrony in Patients With Cardiac Resynchronization Therapy (CRT) - a Real-Time Three Dimensional Echocardiography Approach
Left ventricular dyssynchrony will be assessed by echocardiography using different programming of an implantable cardioverter defibrillator.
Read the detailed description
Left ventricular dyssynchrony will be assessed by echocardiography using different programming of an implantable cardioverter defibrillator using a quadripolar left ventricular lead.
- Conditions
- Heart Failure，Congestive
- Being tested
- Different programming of a CRT 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.
Different programming of a CRT defibrillatorDevice
Different programming of a CRT defibrillator using pacing modalities of a quadripolar left ventricular lead
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular dyssynchrony
Left ventricular dyssynchrony
Measured: 15 minutes
Secondary outcomes (1)
left ventricular ejection fraction
left ventricular ejection fraction
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start1 Mar 2017
- Primary completion1 Jan 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure，CongestiveStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adnan Kastrati, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Responsible party
- Sponsor-investigator, Adnan Kastrati, MD, Deutsches Herzzentrum Muenchen
- Investigators
- Severin Weigand, MD, Principal investigator, Deutsches Herzzentrum Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187470
- Sponsor's protocol ID
- GER-EP-016
- Status last verified
- Mar 2023
- First submitted
- 10 Apr 2017
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weigand S, Karl M, Brkic A, Lennerz C, Grebmer C, Blazek P, Kornmayer M, Schaarschmidt C, Wesemann L, Reents T, Hessling G, Deisenhofer I, Kolb C. The impact of multipole pacing on left ventricular function in patients with cardiac resynchronization therapy - A real-time three-dimensional echocardiography approach. Int J Cardiol. 2018 Dec 1;272:238-243. doi: 10.1016/j.ijcard.2018.08.033. Epub 2018 Aug 15.
PubMed 30121181
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Multipole Pacing (MPP) on Left Ventricular Dyssynchrony in Patients With Cardiac Resynchronization Therapy (CRT) - a Real-Time Three Dimensional Echocardiography Approach
- ClinicalTrials.gov ID
- NCT03187470
- Acronym / sponsor ID
- GER-EP-016
- Conditions
- Heart Failure，Congestive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Adnan Kastrati, MDUniversity, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 15 Jun 2017 (actual)
- 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.
Left ventricular dyssynchrony will be assessed by echocardiography using different programming of an implantable cardioverter defibrillator.
Detailed description
Left ventricular dyssynchrony will be assessed by echocardiography using different programming of an implantable cardioverter defibrillator using a quadripolar left ventricular lead.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Indication for the implantation of a defibrillator with cardiac resynchronisation therapy
Key exclusion criteria (7 listed)
- Cardiac surgery, acute coronary syndrome / myocardial infarction, percutaneous coronary intervention within the past 4 weeks
- Indication for coronary artery revascularisation
- Atrial fibrillation with insufficient rate control
- ASA (American Society of Anesthesiologists) class V or cardiogenic shock
- age <18 years, pregnancy, tutelage
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 |
|---|---|---|
| Different programming of a CRT defibrillatorDifferent programming of a CRT defibrillator using pacing modalities of a quadripolar left ventricular lead | Device | – |
Primary outcome
Left ventricular dyssynchrony
Time frame: 15 minutes
Left ventricular dyssynchrony
1 secondary outcome
left ventricular ejection fraction
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Results publication: PubMed 30121181Weigand S, Karl M, Brkic A, Lennerz C, Grebmer C, Blazek P, Kornmayer M, Schaarschmidt C, Wesemann L, Reents T, Hessling G, Deisenhofer I, Kolb C. The impact of multipole pacing on left ventricular function in patients with cardiac resynchronization therapy - A real-time three-dimensional echocardiography approach. Int J Cardiol. 2018 Dec 1;272:238-243. doi: 10.1016/j.ijcard.2018.08.033. Epub 2018 Aug 15.
- 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.
Severin Weigand, MD principal investigator
Deutsches Herzzentrum Muenchen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different programming of a CRT defibrillator in people with Heart Failure，Congestive, run by Adnan Kastrati, MD 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 1 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 20 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Left ventricular dyssynchrony (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03187470, which also lists 1 linked publication.
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 20 Mar 2023; AzTrials last refreshed its copy on 28 Oct 2026.