Aortic Valve StenosisTAVISTIMNCT02337140
Indication of Permanent Cardiac Parcing After Tanscatheter Aortic Valve Implantation
A study testing Pacemaker SORIN Group KORA DR and transcatheter aortic valve implantation (TAVI) in people with Aortic Valve Stenosis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Since 2002, transcatheter aortic valve implantation (TAVI) has resulted in a dramatic change in the prognosis of patients with aortic valve stenosis illegible to surgery. However, this intervention may induce heavy conduction disorder due to the proximity of the aortic annulus and the conduction pathways. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Pacemaker SORIN Group KORA DR and transcatheter aortic valve implantation (TAVI)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2014to Aug 2016
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient undergoing TAVI through femoral approach
- age > 50 years
- informed and written consent
- patient with social security system
Who cannot join
- patient with previous pacemaker or ICD
- patient under guardianship or curatorship
- patient protected by law
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Indication of Permanent Cardiac Parcing After Tanscatheter Aortic Valve Implantation : Contribution of Electrophysioly Study
Since 2002, transcatheter aortic valve implantation (TAVI) has resulted in a dramatic change in the prognosis of patients with aortic valve stenosis illegible to surgery. However, this intervention may induce heavy conduction disorder due to the proximity of the aortic annulus and the conduction pathways. So far, there is no clear recommandation for clinical management of conduction disorder after TAVI. Standard criterion cannot be applied due to the multiple comorbidity factors observed in these patients. As described in conventional aortic valve surgery, a degree of inflammation and ischemia of the conduction pathways may be involved in the first days. This is the reason underlying the systematic implantation of epicardial electrodes. Such temporary back-up pacing is not possible in TAVI patients.
The primary end-point of this study is to confirm that standard criterion for pacing are reliable in post-TAVI conduction disorders and to analyze the contribution of a systematic electrophysiological study (EPS).
Read more
In TAVI patients, indications for pacing were persistent high-degree atrioventricular block (AVB) or bundle branch block appearance associated to HV interval longer than 70ms, 24 hours after the procedure.
After a two-month follow-up, clinical and ECG evaluation and 24-hour holter monitoring will be realized in patients without pacemaker and compared to data obtained from the devices in pacemaker-implanted patients (% of ventricular pacing > 1% ; presence of more than 1 AVB episod).
Read the detailed description
Inclusions will take place from August 2014 to February 2015. We plan to include 165 consecutive patients with TAVI through a femoral approach.
At the inclusion, clinical baseline and electrocardiographic data will be collected. During the procedure, baseline ECG data as well as conduction disorders will be recorded. An EP study will be performed (measure of AH and HV intervals) before and after TAVI. Aortic surface area, transvalvular mean gradient, presence of periprothetic leak and LV ejection fraction will be determined by echocardiography within the first 24 hours.
After the procedure, a 24-hour ECG monitoring will be done in ICU. A pacemaker will be implanted in case of persistent severe conduction disorders at 24 hours post-TAVI . All patients will be implanted with SORIN Group KORA DR devices to benefit from the AAI-SafeR mode and the AVB episodes automated analysis. All implanted pacemakers will be settled with identical parameters to allow appropriate patient data analysis (AAI-SafeR for sinus rhythm patients and VVIR in chronic atrial fibrillation patients).
In patients with 24-hour persistence of bundle branch block onset after TAVI, a repeated EPS with HV recording will be performed. If HV interval is > 70ms, a pacemaker will be implanted and the patient will be added to the pacemaker-implanted patients. In the absence of persistent conduction disorder 24h after the procedure, no specific supervision will be done.
All patients will have a 2-month follow up. At this time, clinical, ECG and echocardiographic data will be collected. Additional 24-hour Holter ECG monitoring will be performed in non-implanted patients and additional device control will be performed in implanted patients. Pacemaker implantation will be confirmed if there is more than 1% of ventricular pacing or at least one DDD mode switch.
In non-implanted patients, the non-indication for pacing was confirmed in the absence of clinical event and 24-hour Holter ECG recording abnormality.
The secondary endpoint of the study is to define a posteriori risk factors for pacemaker implantation after TAVI included in the liste hereafter:
- Clinical data: age, drug-induced bradycardia, hypertension, ischemic cardiomyopathy, creatinin clearance, troponin value.
- Electrocardiographic data: QRS duration, PR interval, preexisting bundle branch block or AV block, QRS axis, sinus rhythm
- Echocardiographic data : aortic surface area, LV ejection fraction, aortic annulus/prothesis ratio, aortic annulus/balloon diameter ratio
- Electrophysiological data : HV interval before and after TAVI
- Conditions
- Aortic Valve Stenosis
- Being tested
- Pacemaker SORIN Group KORA DR, transcatheter aortic valve implantation (TAVI)
- Keywords
- TAVI, complete AV-block, HV-interval, permanent pacemaker, valve implantation, severe, conduction, disorders
- Medical subject headings
- Aortic Valve Stenosis, Lymphoma, Follicular, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker SORIN Group KORA DRDevice
transcatheter aortic valve implantation (TAVI)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Pacemaker | Experimental | Patient who have been implanted with a pacemaker after TAVI Receives: Device: Pacemaker SORIN Group KORA DR; Procedure: transcatheter aortic valve implantation (TAVI) |
| No Pacemaker | Active comparator | Patient who have not been implanted with a pacemaker after TAVI Receives: Procedure: transcatheter aortic valve implantation (TAVI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
to confirm appropriate pacing indication in patients with conduction disorders after TAVI
Pacemaker implantation will be confirmed if there is more than 1% of ventricular pacing or at least one DDD mode switch in the memories.
In non-implanted patients, the non-indication for pacing was confirmed in the absence of clinical event and 24-hour Holter ECG recording abnormality.
Measured: 2 months
Secondary outcomes (10)
Measures electrocardiographic characteristics before and after implantation
QRS width (milliseconds), space PR (milliseconds), presence of conduction disorders (atrioventricular block, block right or left branch), axis (degrees), sinus rhythm (yes / no)
Measured: 2 months
Measures echographic characteristics
LVEF (in%), aortic valve area (cm2 / m2), aortic regurgitation (grade I / IV)
Measured: 2 months
Type of bioprosthesis
CoreValve, Edwards
Measured: 2 months
Positioning bioprosthesis
high or low relative to the ring plane
Measured: 2 months
Diameter of the implanted bioprosthesis and ratio with the surface of the patient's aortic valve
Measured: 2 months
Taking bradycardia preoperative treatment
yes/no
Measured: 2 months
Electrophysiological data
HV interval measurement before and after the intervention (ms)
Measured: 2 months
Diameter ratio of pre-dilation balloon used during the procedure compared to the patient's valve area
Measured: 2 months
Clinical characteristics
ischemic heart disease history (specify bypass or angioplasty), cardiovascular risk factors (hypertension, diabetes, obesity, smoking ...), patient age
Measured: 2 months
biological characteristics
creatinine before surgery, troponin after surgery
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startAug 2014
- Primary completionApr 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- THOMANN SARAH, MD, Principal investigator, University Hospital, Montpellier France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337140
- Sponsor's protocol ID
- 9357
- Acronym
- TAVISTIM
- Status last verified
- Nov 2016
- First submitted
- 11 Aug 2014
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indication of Permanent Cardiac Parcing After Tanscatheter Aortic Valve Implantation : Contribution of Electrophysioly Study
- ClinicalTrials.gov ID
- NCT02337140
- Acronym / sponsor ID
- TAVISTIM / 9357
- Conditions
- Aortic Valve Stenosis
- Keywords
- TAVI, complete AV-block, HV-interval, permanent pacemaker, valve implantation, severe, conduction, disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 13 Jan 2015 (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.
Since 2002, transcatheter aortic valve implantation (TAVI) has resulted in a dramatic change in the prognosis of patients with aortic valve stenosis illegible to surgery. However, this intervention may induce heavy conduction disorder due to the proximity of the aortic annulus and the conduction pathways. So far, there is no clear recommandation for clinical management of conduction disorder after TAVI. Standard criterion cannot be applied due to the multiple comorbidity factors observed in these patients. As described in conventional aortic valve surgery, a degree of inflammation and ischemia of the conduction pathways may be involved in the first days. This is the reason underlying the systematic implantation of epicardial electrodes. Such temporary back-up pacing is not possible in TAVI patients.
The primary end-point of this study is to confirm that standard criterion for pacing are reliable in post-TAVI conduction disorders and to analyze the contribution of a systematic electrophysiological study (EPS).
In TAVI patients, indications for pacing were persistent high-degree atrioventricular block (AVB) or bundle branch block appearance associated to HV interval longer than 70ms, 24 hours after the procedure.
After a two-month follow-up, clinical and ECG evaluation and 24-hour holter monitoring will be realized in patients without pacemaker and compared to data obtained from the devices in pacemaker-implanted patients (% of ventricular pacing > 1% ; presence of more than 1 AVB episod).
Detailed description
Inclusions will take place from August 2014 to February 2015. We plan to include 165 consecutive patients with TAVI through a femoral approach.
At the inclusion, clinical baseline and electrocardiographic data will be collected. During the procedure, baseline ECG data as well as conduction disorders will be recorded. An EP study will be performed (measure of AH and HV intervals) before and after TAVI. Aortic surface area, transvalvular mean gradient, presence of periprothetic leak and LV ejection fraction will be determined by echocardiography within the first 24 hours.
After the procedure, a 24-hour ECG monitoring will be done in ICU. A pacemaker will be implanted in case of persistent severe conduction disorders at 24 hours post-TAVI . All patients will be implanted with SORIN Group KORA DR devices to benefit from the AAI-SafeR mode and the AVB episodes automated analysis. All implanted pacemakers will be settled with identical parameters to allow appropriate patient data analysis (AAI-SafeR for sinus rhythm patients and VVIR in chronic atrial fibrillation patients).
In patients with 24-hour persistence of bundle branch block onset after TAVI, a repeated EPS with HV recording will be performed. If HV interval is > 70ms, a pacemaker will be implanted and the patient will be added to the pacemaker-implanted patients. In the absence of persistent conduction disorder 24h after the procedure, no specific supervision will be done.
All patients will have a 2-month follow up. At this time, clinical, ECG and echocardiographic data will be collected. Additional 24-hour Holter ECG monitoring will be performed in non-implanted patients and additional device control will be performed in implanted patients. Pacemaker implantation will be confirmed if there is more than 1% of ventricular pacing or at least one DDD mode switch.
In non-implanted patients, the non-indication for pacing was confirmed in the absence of clinical event and 24-hour Holter ECG recording abnormality.
The secondary endpoint of the study is to define a posteriori risk factors for pacemaker implantation after TAVI included in the liste hereafter:
- Clinical data: age, drug-induced bradycardia, hypertension, ischemic cardiomyopathy, creatinin clearance, troponin value.
- Electrocardiographic data: QRS duration, PR interval, preexisting bundle branch block or AV block, QRS axis, sinus rhythm
- Echocardiographic data : aortic surface area, LV ejection fraction, aortic annulus/prothesis ratio, aortic annulus/balloon diameter ratio
- Electrophysiological data : HV interval before and after TAVI
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pacemaker | Experimental | Device: Pacemaker SORIN Group KORA DR, Procedure: transcatheter aortic valve implantation (TAVI)Patient who have been implanted with a pacemaker after TAVI |
| No Pacemaker | Active comparator | Procedure: transcatheter aortic valve implantation (TAVI)Patient who have not been implanted with a pacemaker after TAVI |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient undergoing TAVI through femoral approach
- age > 50 years
- informed and written consent
- patient with social security system
Key exclusion criteria (3 listed)
- patient with previous pacemaker or ICD
- patient under guardianship or curatorship
- patient protected by law
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 |
|---|---|---|
| Pacemaker SORIN Group KORA DR | Device | Pacemaker |
| transcatheter aortic valve implantation (TAVI) | Procedure or surgery | No Pacemaker, Pacemaker |
Primary outcome
to confirm appropriate pacing indication in patients with conduction disorders after TAVI
Time frame: 2 months
Pacemaker implantation will be confirmed if there is more than 1% of ventricular pacing or at least one DDD mode switch in the memories. In non-implanted patients, the non-indication for pacing was confirmed in the absence of clinical event and 24-hour Holter ECG recording abnormality.
10 secondary outcomes
Measures electrocardiographic characteristics before and after implantation
Time frame: 2 months
Measures echographic characteristics
Time frame: 2 months
Type of bioprosthesis
Time frame: 2 months
Positioning bioprosthesis
Time frame: 2 months
Diameter of the implanted bioprosthesis and ratio with the surface of the patient's aortic valve
Time frame: 2 months
Taking bradycardia preoperative treatment
Time frame: 2 months
Electrophysiological data
Time frame: 2 months
Diameter ratio of pre-dilation balloon used during the procedure compared to the patient's valve area
Time frame: 2 months
Clinical characteristics
Time frame: 2 months
biological characteristics
Time frame: 2 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 1 Dec 2016.
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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.
THOMANN SARAH, MD principal investigator
University Hospital, Montpellier France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker SORIN Group KORA DR and transcatheter aortic valve implantation (TAVI) in people with Aortic Valve Stenosis, run by University Hospital, Montpellier at 1 site in France.
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 4 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 1 Dec 2016. 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 France. 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?
to confirm appropriate pacing indication in patients with conduction disorders after TAVI (time frame: 2 months). 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 1 Dec 2016.