Symptomatic Aortic Valve StenosisNCT01801098
Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After TAVI
An observational study of Symptomatic Aortic Valve Stenosis, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
Trial summary
The development of a high grade AV-block is a frequent complication associated with transcatheter aortic valve implantation (TAVI). Patients who were suitable for TAVI will be enrolled in this study. The HV-interval will be determined before and immediately after implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Aortic Valve Stenosis
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2012to Nov 2013
- Phase
- Observational
- 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
Study population: Patients with symptomatic aortic valve stenosis screened for TAVI will be enrolled in this study.
Who may be able to join
- symptomatic aortic valve stenosis
- patients screened for TAVI
- written informed consent
Who cannot join
- unconsciousness, not able to consent
- < 18 years
- permanent pacemaker
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation With a Self-expanding Bioprosthesis
The development of a high grade AV-block is a frequent complication associated with transcatheter aortic valve implantation (TAVI). Patients who were suitable for TAVI will be enrolled in this study. The HV-interval will be determined before and immediately after implantation.
The hypothesis is that a prolonged HV-interval is associated with a high rate of complete AV-block following TAVI.
- Conditions
- Symptomatic Aortic Valve Stenosis
- Keywords
- TAVI, complete AV-block, HV-interval, permanent pacemaker
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of HV interval
HV-interval will be determined by a 5F quadripolar electrode catheter with a CRD-2 curve configuration. Intracardiac signals will be assessed and determined before and after implantation.
Measured: Changes in Baseline to 24 hours
Secondary outcomes (1)
AV-block development after 1 month, 6 months and 12 months
Measured: 1 month, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Aortic Valve StenosisStudies 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
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Malte Kelm, MD, Principal investigator, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital DuesseldorfMarc W. Merx, MD, Principal investigator, Division of Cardiology, Pulmonary Diseases, Vascular Medicine University Hospital DuesseldorfDong-In Shin, MD, Principal investigator, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801098
- Sponsor's protocol ID
- HV-interval prior TAVI
- Status last verified
- Nov 2013
- First submitted
- 6 Feb 2013
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiologic HV-interval as a Predicor for Permanent Pacemaker Implantation After Transcatheter Aortic Valve Implantation With a Self-expanding Bioprosthesis
- ClinicalTrials.gov ID
- NCT01801098
- Acronym / sponsor ID
- HV-interval prior TAVI
- Conditions
- Symptomatic Aortic Valve Stenosis
- Keywords
- TAVI, complete AV-block, HV-interval, permanent pacemaker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und AngiologieUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 28 Feb 2013 (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 development of a high grade AV-block is a frequent complication associated with transcatheter aortic valve implantation (TAVI). Patients who were suitable for TAVI will be enrolled in this study. The HV-interval will be determined before and immediately after implantation.
The hypothesis is that a prolonged HV-interval is associated with a high rate of complete AV-block following TAVI.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic aortic valve stenosis screened for TAVI will be enrolled in this study.
Key inclusion criteria (3 listed)
- symptomatic aortic valve stenosis
- patients screened for TAVI
- written informed consent
Key exclusion criteria (3 listed)
- unconsciousness, not able to consent
- < 18 years
- permanent pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of HV interval
Time frame: Changes in Baseline to 24 hours
HV-interval will be determined by a 5F quadripolar electrode catheter with a CRD-2 curve configuration. Intracardiac signals will be assessed and determined before and after implantation.
1 secondary outcome
AV-block development after 1 month, 6 months and 12 months
Time frame: 1 month, 6 months and 12 months
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 13 Nov 2013.
Related trials for Symptomatic Aortic Valve Stenosis
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
RecruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
Non-obstructive Hypertrophic Cardiomyopathy
Active, not recruitingPhase 3
A Study to Learn More About How Well Aficamten Works in Japanese Participants With Symptomatic Obstructive Hypertrophic Cardiomyopathy
Obstructive Hypertrophic Cardiomyopathy
RecruitingObservational study
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)
Enrolling by invitationPhase 2/3
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
Symptomatic Hypertrophic Cardiomyopathy (HCM)
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.
Malte Kelm, MD principal investigator
Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
Marc W. Merx, MD principal investigator
Division of Cardiology, Pulmonary Diseases, Vascular Medicine University Hospital Duesseldorf
Dong-In Shin, MD principal investigator
Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
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 Symptomatic Aortic Valve Stenosis, run by Klinik für Kardiologie, Pneumologie und Angiologie 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 3 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: finished, as of the sponsor's last update on 13 Nov 2013. 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?
Determination of HV interval (time frame: Changes in Baseline to 24 hours). 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 13 Nov 2013.