Tricuspid RegurgitationPhase 4NCT01093001
Tricuspid Regurgitation Study
A Phase 4 study testing Echo in people with Tricuspid Regurgitation and Right Ventricular Dysfunction, run by Mayo Clinic at 1 site in United States.
Trial summary
The effect of cardiac pacing leads on tricuspid regurgitation is unclear. This study will determine whether using a smaller diameter leads and an alternate position in the ventricle, the proximal septum, will reduce tricuspid regurgitation than larger leads placed in the apex. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tricuspid Regurgitation, Right Ventricular Dysfunction, Left Ventricular Dysfunction
- What is being tested?
- Echo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to May 2016
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of either sex
- Patient is recommended to receive a pacemaker or an ICD
- Provide informed consent
Who cannot join
- Pregnant or breastfeeding women
- Congenital heart disease
- Pre-existing moderate or severe TR
- An existing pacemaker or defibrillator
- Pulmonary hypertension
- Pacemaker dependence
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- Unable to give informed consent
- Not feasible for patient to be followed up at Mayo Clinic
- Acute myocardial infarction within 7 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cardiac Pacing Leads on Tricuspid Regurgitation
The effect of cardiac pacing leads on tricuspid regurgitation is unclear. This study will determine whether using a smaller diameter leads and an alternate position in the ventricle, the proximal septum, will reduce tricuspid regurgitation than larger leads placed in the apex.
Read the detailed description
Leads are commonly placed in the right ventricular apex. It is not known whether placing similar leads higher on the septum where there will be less redundancy or pressure on the septal leaflet will change the extent and severity of tricuspid regurgitation following pacemaker/ICD implantation. Data has shown that right ventricular pacing can give rise to right ventricular dysfunction, which in turn may give rise to enlargement of the right ventricle and cause tricuspid regurgitation.
The study will answer the clinically relevant questions on device lead-related tricuspid regurgitation.
This study is a single center prospective study at the Mayo Clinic, Rochester. The study will enroll 200 eligible subjects and follow for 12 months. 50 pacemaker subjects will be randomized to right ventricular apex pacing 50 pacemaker subjects will be randomized to right ventricular septum pacing 50 pacemaker subjects will be randomized to left ventricular pacing via coronary sinus 50 ICD subjects will be enrolled with right ventricular apex pacing.
A baseline heart failure assessment and Two Dimensional echocardiography will be performed before device implant.
A Two Dimensional echo will be performed 24 hours after device implant. If significance TR is present a Three Dimensional echo will be performed. At 12 months post implant heart failure assessment and Two Dimensional echo will be performed.
- Being tested
- Echo
- Keywords
- Reduce Tricuspid Regurgitation, Reduce Right Ventricular pacing, Lead position, Lead size
- Medical subject headings
- Tricuspid Valve Insufficiency, Ventricular Dysfunction, Right, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchoOther
Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.
EchoOther
Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation
EchoOther
Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.
EchoOther
Also called Medtronic Starfix lead
Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.
| Study group | Role | What they receive |
|---|---|---|
| Lead size | Active comparator | The pacemaker lead will be < or = to 7Fr. The ICD lead will be 9 Fr. Receives: Other: Echo |
| RV Lead position | Active comparator | 50 patients will be randomized to RV apex lead placement. Receives: Other: Echo |
| Mid-Septum Lead position | Active comparator | 50 patients will be randomized to RV mid-septum lead placement. Receives: Other: Echo |
| CS lead position | Active comparator | 50 patients will have lead placed in the CS Receives: Other: Echo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Tricuspid Regurgitation using smaller diameter lead and placing the lead on the proximal septum.
Measured: 12 months
Secondary outcomes (1)
Left Ventricular lead placement will be associated with least amount of TR because of avoiding crossing the tricuspid valve and by virtue of relatively more synchronous ventricular contractions.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2015
- Study completionMay 2016
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 Tricuspid RegurgitationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Principal investigator, Yong-Mei Cha, Mayo Clinic
- Investigators
- Yong-Mei Cha, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093001
- Sponsor's protocol ID
- 08-008690
- Status last verified
- Nov 2016
- First submitted
- 24 Mar 2010
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
1. Lin G, Nishimura R, Connolly H, Dearani J, Sundt T, Hayes D: Severe symptomatic tricuspid valve regurgitation due to permanent pacemaker or implantable cardioverter-defibrillator leads. JACC 2005; 45:1672-1675. 2. Leibowitz D, Rosenheck S, Pollak A, Geist M, Gilon D: Transvenous pacemaker leads do not worsen tricuspid regurgitation: a prospective echocardiographic study. Arrhythmias, Electrophysiology and Electrocardiography 2000; 93:74-77. 3. Kucukarslan N, Kirilmaz A, Ulusoy E, Yokusoglu M, Gramatnikovski N, Ozal E, Tatar H: Tricuspid insufficiency does not increase early after permanent implantation of pacemaker leads. J Card Surg 2006; 21:391-394. 4. Wilkoff B, Invesigators DT: The dual chamber and WI implantable defibrillator (DAVID) Trial: rationale, design, results, clinical implications and lessons for future trials. Cardiac Electrophysiol Review 2004; 7:468-472.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cardiac Pacing Leads on Tricuspid Regurgitation
- ClinicalTrials.gov ID
- NCT01093001
- Acronym / sponsor ID
- 08-008690
- Keywords
- Reduce Tricuspid Regurgitation, Reduce Right Ventricular pacing, Lead position, Lead size
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- May 2010
- Primary completion
- Sep 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 Mar 2010 (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 effect of cardiac pacing leads on tricuspid regurgitation is unclear. This study will determine whether using a smaller diameter leads and an alternate position in the ventricle, the proximal septum, will reduce tricuspid regurgitation than larger leads placed in the apex.
Detailed description
Leads are commonly placed in the right ventricular apex. It is not known whether placing similar leads higher on the septum where there will be less redundancy or pressure on the septal leaflet will change the extent and severity of tricuspid regurgitation following pacemaker/ICD implantation. Data has shown that right ventricular pacing can give rise to right ventricular dysfunction, which in turn may give rise to enlargement of the right ventricle and cause tricuspid regurgitation.
The study will answer the clinically relevant questions on device lead-related tricuspid regurgitation.
This study is a single center prospective study at the Mayo Clinic, Rochester. The study will enroll 200 eligible subjects and follow for 12 months. 50 pacemaker subjects will be randomized to right ventricular apex pacing 50 pacemaker subjects will be randomized to right ventricular septum pacing 50 pacemaker subjects will be randomized to left ventricular pacing via coronary sinus 50 ICD subjects will be enrolled with right ventricular apex pacing.
A baseline heart failure assessment and Two Dimensional echocardiography will be performed before device implant.
A Two Dimensional echo will be performed 24 hours after device implant. If significance TR is present a Three Dimensional echo will be performed. At 12 months post implant heart failure assessment and Two Dimensional echo will be performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lead size | Active comparator | Other: EchoThe pacemaker lead will be < or = to 7Fr. The ICD lead will be 9 Fr. |
| RV Lead position | Active comparator | Other: Echo50 patients will be randomized to RV apex lead placement. |
| Mid-Septum Lead position | Active comparator | Other: Echo50 patients will be randomized to RV mid-septum lead placement. |
| CS lead position | Active comparator | Other: Echo50 patients will have lead placed in the CS |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of either sex
Key exclusion criteria (9 listed)
- Pregnant or breastfeeding women
- Congenital heart disease
- Pre-existing moderate or severe TR
- An existing pacemaker or defibrillator
- Pulmonary hypertension
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 |
|---|---|---|
| EchoTwo dimensional echocardiography will be performed to reassess Tricuspid Regurgitation. | Other | Lead size |
| EchoTwo dimensional echocardiography will be performed to reassess Tricuspid Regurgitation | Other | RV Lead position |
| EchoTwo dimensional echocardiography will be performed to reassess Tricuspid Regurgitation. | Other | Mid-Septum Lead position |
| EchoAlso: Medtronic Starfix leadTwo dimensional echocardiography will be performed to reassess Tricuspid Regurgitation. | Other | CS lead position |
Primary outcome
Decrease in Tricuspid Regurgitation using smaller diameter lead and placing the lead on the proximal septum.
Time frame: 12 months
1 secondary outcome
Left Ventricular lead placement will be associated with least amount of TR because of avoiding crossing the tricuspid valve and by virtue of relatively more synchronous ventricular contractions.
Time frame: 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 3 Nov 2016.
- Background1. Lin G, Nishimura R, Connolly H, Dearani J, Sundt T, Hayes D: Severe symptomatic tricuspid valve regurgitation due to permanent pacemaker or implantable cardioverter-defibrillator leads. JACC 2005; 45:1672-1675. 2. Leibowitz D, Rosenheck S, Pollak A, Geist M, Gilon D: Transvenous pacemaker leads do not worsen tricuspid regurgitation: a prospective echocardiographic study. Arrhythmias, Electrophysiology and Electrocardiography 2000; 93:74-77. 3. Kucukarslan N, Kirilmaz A, Ulusoy E, Yokusoglu M, Gramatnikovski N, Ozal E, Tatar H: Tricuspid insufficiency does not increase early after permanent implantation of pacemaker leads. J Card Surg 2006; 21:391-394. 4. Wilkoff B, Invesigators DT: The dual chamber and WI implantable defibrillator (DAVID) Trial: rationale, design, results, clinical implications and lessons for future trials. Cardiac Electrophysiol Review 2004; 7:468-472.
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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.
Yong-Mei Cha, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Echo in people with Tricuspid Regurgitation and Right Ventricular Dysfunction, run by Mayo Clinic at 1 site in United States.
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 9 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 3 Nov 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Decrease in Tricuspid Regurgitation using smaller diameter lead and placing the lead on the proximal septum. (time frame: 12 months). 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 NCT01093001, 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 3 Nov 2016.