Aortic Valve DiseaseNCT01631188

Use of Transvenous Pacing Wire During Minimally Invasive Port Access Aortic Valve Surgery

A study testing Minimally Invasive Aortic Valve, Minimally Invasive Aortic Valve Surgery and Manipulation in OR surgical technique in people with Aortic Valve Disease, run by Rutgers, The State University of New Jersey.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The study is being done to determine if the Endovent pulmonary catheter kit, used for port access surgery, can be used as a passageway for a pacing wire. The study hypothesis is that the Endovent kit can be used effectively as a passageway for a pacing wire system. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Valve Disease
What is being tested?: Minimally Invasive Aortic Valve, Minimally Invasive Aortic Valve Surgery and Manipulation in OR surgical technique
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: No sites listed yet
Study dates: Dec 2011to Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

>= 18 years of age patients having aortic valve port access surgery
Scheduled for Minimally Invasive Port Access Aortic Valve Study
Patient must agree to study participation; understand and sign the written informed consent

Who cannot join

< 18 years of age Patients are excluded if they are not having minimaly invasive aortic valve surgery not having aortic valve port access surgery

About this study

Read the detailed description

Many times cardiac surgery requires the use of epicardial pacing in order to wean the patient from bypass. During minimally invasive port access valve surgery, it may not be possible to place the leads on the surface of the heart because of the limited surgical exposure. In this case, transvenous pacing is used. Minimally invasive port access surgery uses specially designed, FDA approved catheters for the procedure. We wish to review the effectiveness of being able to place the wires through the catheters and pace the patient.

Conditions: Aortic Valve Disease
Being tested: Minimally Invasive Aortic Valve, Minimally Invasive Aortic Valve Surgery, Manipulation in OR surgical technique
Keywords: Minimally Invasive Surgery, Port Access Surgery, Heart, Pacing, Wire, MICS, Cardiac Bypass, Epicardial pacing, pacing catheter, pacing wire, pacing swan, pacing pulmonary catheter, Pulmonary Endovent, Catheter, Aortic Valve Surgery, Edwards Lifesciences
Medical subject headings: Aortic Valve Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Minimally Invasive Aortic ValveProcedure or surgery
Patients having minimally invasive aortic valve surgery will have a pacing wire placed through the endovent catheter. The anesthesiologist will attempt to pace the ventricle with this wire if needed to wean from bypass.
Minimally Invasive Aortic Valve SurgeryProcedure or surgery
Also called AVR, Mini AVR, Minimally invasive Port Access Surgery
The Anesthesiologist will advance a pacing wire through the Endovent Catheter under TEE in order to pace the heart when the subject is coming off the Cardiopulmonary bypass machine
Manipulation in OR surgical techniqueDevice
Also called AVR, mini avr,
Endovent and pacing wire when coming off cardiopulmonary bypass

Study groups in NCT01631188
Study group	Role	What they receive
Aortic Valve Replacement	Experimental	During surgery your doctor will utilize a new technique using surgical equipment that have already been FDA Approved for other indication. The combination of the equipment and technique will be experimental and will be closely evaluated during and after each case. Receives: Procedure: Minimally Invasive Aortic Valve; Procedure: Minimally Invasive Aortic Valve Surgery; Device: Manipulation in OR surgical technique

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Were the Endovent Pacing Wire Were Able to Obtain a Ventricular Sensing Signal
Heart to begin pacing upon passing the wire through the catheter to the heart. The catheter would be to be able to pace the heart, with 5 or less milliamps, post heart surgery
Measured: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.
Number of Participants That Required Pacing Who Were Able to be Paced
To be able to pace the heart post aortic valve replacement surgery
Measured: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.

Secondary outcomes (1)

Number of Participants Who Developed Abnormal Blood Pressure or Heart, and/or Arrhythmias Potentially Related to the Pacing Endovent
Subjects hemodynamic status will be measured and assessed throughout the study including all vital signs
Measured: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Dec 2015

First posted29 Jun 2012 (estimated)
Study startDec 2011
Primary completionDec 2015
Study completionDec 2015

Why it stopped: lost nurse researcher support

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
More trials run by Rutgers, The State University of New JerseyThe 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01631188
Sponsor's protocol ID: 0220110241
Status last verified: Nov 2021
First submitted: 12 Mar 2012
Last updated: 16 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

All Aortic Valve Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of Transvenous Pacing Wire During Minimally Invasive Port Access Aortic Valve Surgery
ClinicalTrials.gov ID: NCT01631188
Acronym / sponsor ID: 0220110241
Conditions: Aortic Valve Disease
Keywords: Minimally Invasive Surgery, Port Access Surgery, Heart, Pacing, Wire, MICS, Cardiac Bypass, Epicardial pacing
Study type: Interventional
Recruitment status: TerminatedReason stopped: lost nurse researcher support
Enrolment: 100 participants (actual)
Lead sponsor: Rutgers, The State University of New JerseyUniversity, hospital or other
Study start: Dec 2011
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 29 Jun 2012 (estimated)
Results: Posted 16 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Aortic Valve Replacement	Experimental	Procedure: Minimally Invasive Aortic Valve, Procedure: Minimally Invasive Aortic Valve Surgery, Device: Manipulation in OR surgical techniqueDuring surgery your doctor will utilize a new technique using surgical equipment that have already been FDA Approved for other indication. The combination of the equipment and technique will be experimental and will be closely evaluated during and after each case.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

>= 18 years of age patients having aortic valve port access surgery
Scheduled for Minimally Invasive Port Access Aortic Valve Study
Patient must agree to study participation; understand and sign the written informed consent

Key exclusion criteria (1 listed)

< 18 years of age Patients are excluded if they are not having minimaly invasive aortic valve surgery not having aortic valve port access surgery

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
Minimally Invasive Aortic ValvePatients having minimally invasive aortic valve surgery will have a pacing wire placed through the endovent catheter. The anesthesiologist will attempt to pace the ventricle with this wire if needed to wean from bypass.	Procedure or surgery	Aortic Valve Replacement
Minimally Invasive Aortic Valve SurgeryAlso: AVR, Mini AVR, Minimally invasive Port Access SurgeryThe Anesthesiologist will advance a pacing wire through the Endovent Catheter under TEE in order to pace the heart when the subject is coming off the Cardiopulmonary bypass machine	Procedure or surgery	Aortic Valve Replacement
Manipulation in OR surgical techniqueAlso: AVR, mini avr,Endovent and pacing wire when coming off cardiopulmonary bypass	Device	Aortic Valve Replacement

Primary outcome

Number of Participants Were the Endovent Pacing Wire Were Able to Obtain a Ventricular Sensing Signal
Time frame: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.
Heart to begin pacing upon passing the wire through the catheter to the heart. The catheter would be to be able to pace the heart, with 5 or less milliamps, post heart surgery
Number of Participants That Required Pacing Who Were Able to be Paced
Time frame: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.
To be able to pace the heart post aortic valve replacement surgery

1 secondary outcome

Number of Participants Who Developed Abnormal Blood Pressure or Heart, and/or Arrhythmias Potentially Related to the Pacing Endovent
Time frame: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.

Results and safety

Results posted to the registry on 16 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aortic Valve Replacement	100	25

Primary outcome: Number of Participants Were the Endovent Pacing Wire Were Able to Obtain a Ventricular Sensing Signal

Time frame: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.. Count of participants. Unit: Participants

Measure	Aortic Valve Replacement n = 23
Value	23

Population analysed: 23 patients were analyzed. Patient # 12 (male, 75 year) and # 19 (male, 61 year) were eliminated from the study after an intraoperative TEE showed additional pathology that changed the operation needed, and thus the operation from a "mini AVR" to a full sternotomy eliminating the need for the study Endovent pacing lead.

Primary outcome: Number of Participants That Required Pacing Who Were Able to be Paced

Time frame: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.. Count of participants. Unit: Participants

Measure	Aortic Valve Replacement n = 12
Value	12

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aortic Valve Replacement	1 of 23 (4.3%)	0 of 23 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Aortic Valve Disease

Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic

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.

Enrique L Pantin, MD principal investigator

Rutgers, The State University of New Jersey

Jonathan Kraidin, MD study director

Rutgers, The State University of New Jersey

Questions about this trial

What is this clinical trial studying?

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 1 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 16 Nov 2021. 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?

Yes. Results are posted in the registry (first posted 16 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Were the Endovent Pacing Wire Were Able to Obtain a Ventricular Sensing Signal (time frame: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.). The study lists 2 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 NCT01631188.

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 16 Nov 2021.