Aortic StenosisPAMITNCT02768064
Temporary Pacemaker in Transcatheter Aortic Valve Implantation Patients
A study testing temporary pacemaker insertion in people with Aortic Stenosis, run by Hadassah Medical Organization.
Trial summary
During Transcatheter aortic valve implantation (TAVI) procedure, a new valve is implanted. The valve can be CoreValve (Medtronic Company) or Edward SAPIENS (Edwards Company). All TAVI patients require a temporary pacemaker(PMK), which is usually performed by insertion of a standard temporary electrode through the… Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- temporary pacemaker insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 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 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All TAVI patients
Who cannot join
- Existing contraindication for either femoral or jugular venous access
- Refused informed consent
- Permanent PMK
- Platelets count less than 50 K.
Trial locations and contacts
No sites are listed yet.
About this study
During Transcatheter aortic valve implantation (TAVI) procedure, a new valve is implanted. The valve can be CoreValve (Medtronic Company) or Edward SAPIENS (Edwards Company).
All TAVI patients require a temporary pacemaker(PMK), which is usually performed by insertion of a standard temporary electrode through the femoral vein. The temporary PMK is associated with a small but significant rate of complications.
Read more
The PMK is usually removed immediately at the end of the TAVI procedure, only when using the Edward SAPIENS valve. The CoreValve valve is more associated with conduction complications, and thus the PMK is later removed in these cases.
PMK Complications seen include:
- Right Ventricle perforation by temporary electrode, leading to Pericardial bleeding, in some cases with Tamponade
- Infection
- Electrode dislocation causing In-effective pacing (and/or sensing)
- Prolonged bed rest
- Prolonged hospitalization
- Access related problems (hematoma, pneumothorax) In a review of a large cohort (1) of patients from Milan (JACC 2012) the rate of tamponade was 4.3% most of which was associated with the temporary PMK.
Read the detailed description
The investigators had experienced not infrequent occurrences of temporary electrode associated tamponade, either acutely after Transcatheter aortic valve implantation (TAVI) completion, or delayed, in association with the electrode removal.
The tamponade rate in patients with a temporary pacemaker(PMK) was 14/150 (9.3%). Not all tamponade cases were related to the temporary PMK, 2 occurred in the setting of catastrophic annular rupture and one of the first cases was related to the Left Ventricle stiff wire.
The investigators also noted a significant prolongation of bed rest and hospital stay in patients with temporary PMK.
Using a flexible permanent pacing electrode which is actively fixed to the Right Ventricle and is placed through the jugular vein will reduce pacing-related complication rates (due to the flexibility of the electrode), time to ambulation (due to the fixation of the electrode), hospital stay and also unnecessary PMK. Cost will also be reduced due to prevention of complications and reduction in Intensive Cardiac Care Unit time.
Procedure time might be slightly prolonged since the placement of the standard electrode is more timely, however this prolongation is negligible, and the benefits of the flexible permanent pacing electrode are worth this prolongation
- Conditions
- Aortic Stenosis
- Being tested
- temporary pacemaker insertion
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temporary pacemaker insertionDevice
Insertion of pacemaker electrode (Medtronic flow direct pacing catheter), connect to external pacemaker (Medtronic).
| Study group | Role | What they receive |
|---|---|---|
| Flexible screwed electrode | Experimental | In the TAVI patients, during the intervention procedure, a temporary pacemaker will be implanted, using a flexible screwed electrode. Receives: Device: temporary pacemaker insertion |
| Stiff standard electrode | Active comparator | In the TAVI patients, during the intervention procedure, a temporary pacemaker will be implanted, using a stiff standard temporary electrode Receives: Device: temporary pacemaker insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with pericardial effusion with or without tamponade
Pericardial effusion estimated by echocardiography, will be done during the hospitalization. It will be described as minimal/mild/moderate/large
Measured: 1 week
Number of participants with Electrode Dislocation
Electrode Dislocation (sensing / pacing problems, requiring lead re-positioning).
The dislocation will be diagnosed by chest X ray or by sensing / pacing parameters.
Measured: 1 week
Number of participants with Bleeding complications
Bleeding complications, described as local hematoma within the area of the electrode insertion, during the procedure or the hospitalization.
Measured: 1 week
Number of participants with Infections complications
Infections complications, described as fever above 38.0 celsius degree or positive blood culture during the hospitalization after the procedure.
Measured: 1 week
Number of participants with access site complications
Access site complications describe as perforation of near organs (jugular artery)
Measured: 1 week
Number of participants with Pneumothorax
Pneumothorax diagnosed by clinical examination and CXR within 3 days after the procedure.
Measured: 1 week
Number of participants with pacemaker failure
Rates of Pacing or sensing failure during the procedure, or the days after,
Measured: 1 week
Secondary outcomes (7)
An implantation of permanent pacemaker
An implantation of permanent pacemaker (of any company, of any reason) within a year after TAVI in any hospital. The data will be collect from the hospital medical record system, and the patient report
Measured: one year
The time (in days) the patient was able to get down from his bed to a chair, after the procedure
The number of days from the TAVI procedure to the first time the patient was able to get down from his bad and sit on a chair. The data will be collected from the nurse description in the medical record.
Measured: week
The time (in days) the patients has stayed in Intensive Cardiac Care Unit
The number of days the patient was hospitalized in Intensive Cardiac Care Unit. The number will be calculated from the end of the TAVI procedure, till the patient went home or moved into the Cardiology department.
Measured: 2 weeks
The Cost of Pacing equipment
Will be calculate by the sum of the electrode cost and the vascular shith cost
Measured: 1 week
The TAVI procedure time
Will be taken from the technician report of starting and ending of the TAVI procedure
Measured: 1 day
The TAVI fluoroscopic time
Will be taken from technician report of Fluoroscopic time
Measured: 1 day
The permanent pacemaker activation (if implanted)
If a pacemaker was implanted to the patient, the data will be collected from the interrogation of the pacemaker.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orlev Amir, Hadassah Medical Organization
- Investigators
- Amir Orlev, Dr, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768064
- Sponsor's protocol ID
- 065015-HMO-CTIL
- Acronym
- PAMIT
- Status last verified
- May 2016
- First submitted
- 10 Feb 2016
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Webb JG, Wood DA. Current status of transcatheter aortic valve replacement. J Am Coll Cardiol. 2012 Aug 7;60(6):483-92. doi: 10.1016/j.jacc.2012.01.071. Epub 2012 Jun 27.
PubMed 22749306Barbash IM, Waksman R, Pichard AD. Prevention of right ventricular perforation due to temporary pacemaker lead during transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2013 Apr;6(4):427. doi: 10.1016/j.jcin.2013.01.135. No abstract available.
PubMed 23597613Rezq A, Basavarajaiah S, Latib A, Takagi K, Hasegawa T, Figini F, Cioni M, Franco A, Montorfano M, Chieffo A, Maisano F, Corvaja N, Alfieri O, Colombo A. Incidence, management, and outcomes of cardiac tamponade during transcatheter aortic valve implantation: a single-center study. JACC Cardiovasc Interv. 2012 Dec;5(12):1264-72. doi: 10.1016/j.jcin.2012.08.012.
PubMed 23257375
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporary Pacemaker in Transcatheter Aortic Valve Implantation Patients
- ClinicalTrials.gov ID
- NCT02768064
- Acronym / sponsor ID
- PAMIT / 065015-HMO-CTIL
- Conditions
- Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 11 May 2016 (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.
During Transcatheter aortic valve implantation (TAVI) procedure, a new valve is implanted. The valve can be CoreValve (Medtronic Company) or Edward SAPIENS (Edwards Company).
All TAVI patients require a temporary pacemaker(PMK), which is usually performed by insertion of a standard temporary electrode through the femoral vein. The temporary PMK is associated with a small but significant rate of complications.
The PMK is usually removed immediately at the end of the TAVI procedure, only when using the Edward SAPIENS valve. The CoreValve valve is more associated with conduction complications, and thus the PMK is later removed in these cases.
PMK Complications seen include:
- Right Ventricle perforation by temporary electrode, leading to Pericardial bleeding, in some cases with Tamponade
- Infection
- Electrode dislocation causing In-effective pacing (and/or sensing)
- Prolonged bed rest
- Prolonged hospitalization
- Access related problems (hematoma, pneumothorax) In a review of a large cohort (1) of patients from Milan (JACC 2012) the rate of tamponade was 4.3% most of which was associated with the temporary PMK.
Detailed description
The investigators had experienced not infrequent occurrences of temporary electrode associated tamponade, either acutely after Transcatheter aortic valve implantation (TAVI) completion, or delayed, in association with the electrode removal.
The tamponade rate in patients with a temporary pacemaker(PMK) was 14/150 (9.3%). Not all tamponade cases were related to the temporary PMK, 2 occurred in the setting of catastrophic annular rupture and one of the first cases was related to the Left Ventricle stiff wire.
The investigators also noted a significant prolongation of bed rest and hospital stay in patients with temporary PMK.
Using a flexible permanent pacing electrode which is actively fixed to the Right Ventricle and is placed through the jugular vein will reduce pacing-related complication rates (due to the flexibility of the electrode), time to ambulation (due to the fixation of the electrode), hospital stay and also unnecessary PMK. Cost will also be reduced due to prevention of complications and reduction in Intensive Cardiac Care Unit time.
Procedure time might be slightly prolonged since the placement of the standard electrode is more timely, however this prolongation is negligible, and the benefits of the flexible permanent pacing electrode are worth this prolongation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexible screwed electrode | Experimental | Device: temporary pacemaker insertionIn the TAVI patients, during the intervention procedure, a temporary pacemaker will be implanted, using a flexible screwed electrode. |
| Stiff standard electrode | Active comparator | Device: temporary pacemaker insertionIn the TAVI patients, during the intervention procedure, a temporary pacemaker will be implanted, using a stiff standard temporary electrode |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All TAVI patients
Key exclusion criteria (4 listed)
- Existing contraindication for either femoral or jugular venous access
- Refused informed consent
- Permanent PMK
- Platelets count less than 50 K.
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 |
|---|---|---|
| temporary pacemaker insertionInsertion of pacemaker electrode (Medtronic flow direct pacing catheter), connect to external pacemaker (Medtronic). | Device | Flexible screwed electrode, Stiff standard electrode |
Primary outcome
Number of participants with pericardial effusion with or without tamponade
Time frame: 1 week
Pericardial effusion estimated by echocardiography, will be done during the hospitalization. It will be described as minimal/mild/moderate/large
Number of participants with Electrode Dislocation
Time frame: 1 week
Electrode Dislocation (sensing / pacing problems, requiring lead re-positioning). The dislocation will be diagnosed by chest X ray or by sensing / pacing parameters.
Number of participants with Bleeding complications
Time frame: 1 week
Bleeding complications, described as local hematoma within the area of the electrode insertion, during the procedure or the hospitalization.
Number of participants with Infections complications
Time frame: 1 week
Infections complications, described as fever above 38.0 celsius degree or positive blood culture during the hospitalization after the procedure.
Number of participants with access site complications
Time frame: 1 week
Access site complications describe as perforation of near organs (jugular artery)
Number of participants with Pneumothorax
Time frame: 1 week
Pneumothorax diagnosed by clinical examination and CXR within 3 days after the procedure.
Number of participants with pacemaker failure
Time frame: 1 week
Rates of Pacing or sensing failure during the procedure, or the days after,
7 secondary outcomes
An implantation of permanent pacemaker
Time frame: one year
The time (in days) the patient was able to get down from his bed to a chair, after the procedure
Time frame: week
The time (in days) the patients has stayed in Intensive Cardiac Care Unit
Time frame: 2 weeks
The Cost of Pacing equipment
Time frame: 1 week
The TAVI procedure time
Time frame: 1 day
The TAVI fluoroscopic time
Time frame: 1 day
The permanent pacemaker activation (if implanted)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Background: PubMed 22749306Webb JG, Wood DA. Current status of transcatheter aortic valve replacement. J Am Coll Cardiol. 2012 Aug 7;60(6):483-92. doi: 10.1016/j.jacc.2012.01.071. Epub 2012 Jun 27.
- Background: PubMed 23597613Barbash IM, Waksman R, Pichard AD. Prevention of right ventricular perforation due to temporary pacemaker lead during transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2013 Apr;6(4):427. doi: 10.1016/j.jcin.2013.01.135. No abstract available.
- Background: PubMed 23257375Rezq A, Basavarajaiah S, Latib A, Takagi K, Hasegawa T, Figini F, Cioni M, Franco A, Montorfano M, Chieffo A, Maisano F, Corvaja N, Alfieri O, Colombo A. Incidence, management, and outcomes of cardiac tamponade during transcatheter aortic valve implantation: a single-center study. JACC Cardiovasc Interv. 2012 Dec;5(12):1264-72. doi: 10.1016/j.jcin.2012.08.012.
- 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.
Amir Orlev, Dr principal investigator
Hadassah Medical Organization
Questions about this trial
What is this clinical trial studying?
A study testing temporary pacemaker insertion in people with Aortic Stenosis, run by Hadassah Medical Organization.
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 4 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 11 May 2016. 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?
Contact Amir Orlev, Dr (972-2-6776564, amir.orlev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with pericardial effusion with or without tamponade (time frame: 1 week). The study lists 7 primary outcomes in all. 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 NCT02768064, which also lists 3 linked publications.
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 11 May 2016.