BradyarrhythmiasPhase 4SAFE-LVPACENCT01717469
Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias
A Phase 4 study testing Left ventricular pacing through coronary sinus tributaries (Attain StarFix) and Right ventricular pacing (Medtronic) in people with Bradyarrhythmias and Arrhythmias, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Previous experimental and clinical studies have consistently suggested that right ventricular (RV) apical pacing has important adverse effects. Ventricular pacing, however, is required, and cannot be reduced in many patients with atrioventricular block. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bradyarrhythmias, Arrhythmias, Atrioventricular Block
- What is being tested?
- Left ventricular pacing through coronary sinus tributaries (Attain StarFix) and Right ventricular pacing (Medtronic)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2012to Jun 2017
- 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
- Older than 18 years
- Pacemaker initial implant by transvenous approach
- Presence of AV block
- Presence of atrial fibrillation / atrial flutter with slow ventricular response
- Left ventricular systolic function > 0.40
- Subject agreed to participate and signed the consent form
Who cannot join
- Absence of venous access
- Impediment of venous access due to presence of intracardiac defects
- Impediment of venous access due to presence of tricuspid valve prosthesis
- Need for radiotherapy in the chest
- Presence of chest deformity
- Pregnancy
- Life expectancy of less than one year
- Contraindication to administration of iodinated contrast (creatinine > 3.0) Unable to attend the follow-up appointments
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403-900
Robeto Costa, MD PhD, 55-11-2661 ext. 5284, rcosta@gmail.com
Katia R Silva, RN PhD, 9195978619, katia.research@gmail.com
About this study
Official title: Randomized Clinical Study to Assess the Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias
Previous experimental and clinical studies have consistently suggested that right ventricular (RV) apical pacing has important adverse effects. Ventricular pacing, however, is required, and cannot be reduced in many patients with atrioventricular block. The SAFE-LVPACE study is a randomized controlled trial that compare the effects of conventional right ventricular (RV) pacing vs. left ventricular (LV) in patients with AV block.
Read the detailed description
Over the past several years, there has been growing concern over the significant deleterious effects of RV pacing, including electromechanical dyssynchrony, proarrhythmia and development of heart failure (HF). However, it remains unclear whether pacing-related ventricular dyssynchrony can translate into significant LV structural changes and produce important clinical impairment in an average pacemaker population with compromised AV conduction. Alternatively, left ventricular pacing has been shown to minimize ventricular dyssynchrony and to improve symptoms and prognosis in patients with mild to moderated systolic HF and prolonged QRS duration.
This randomized controlled study is been conducted to compare the effects of conventional right ventricular (RV) pacing vs. left ventricular (LV) in patients with AV block. The hypothesis is that isolated LV pacing through the coronary sinus can be used safely and provide greater hemodynamic benefits to patients with AV block and normal ventricular function who require only the correction of heart rate.
Specifically, the investigator aims are to evaluate the safety, efficacy and the effects of left ventricular pacing using active-fixation coronary sinus lead-the Attain StarFix® Model 4195 OTW Lead, compared to right ventricular pacing in patients with implantation criteria for conventional pacemaker stimulation.
- Conditions
- Bradyarrhythmias, Arrhythmias, Atrioventricular Block, Ventricular Dysfunction, Cardiovascular Disease
- Being tested
- Left ventricular pacing through coronary sinus tributaries (Attain StarFix), Right ventricular pacing (Medtronic)
- Keywords
- Pacemaker, Pacemaker implantation, Coronary sinus, Ventricular dysfunction, Right ventricular pacing, Left ventricular pacing
- Medical subject headings
- Bradycardia, Arrhythmias, Cardiac, Atrioventricular Block, Ventricular Dysfunction, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left ventricular pacing through coronary sinus tributaries (Attain StarFix)Device
Also called Attain StarFix® Model 4195 OTW Lead
Left ventricular pacing in patients with bradycardia
Right ventricular pacing (Medtronic)Device
Also called Right ventricular lead Medtronic 5076-58
Conventional right ventricular pacing in patients with bradycardia.
| Study group | Role | What they receive |
|---|---|---|
| RV Pacing | Active comparator | Right ventricular pacing Receives: Device: Right ventricular pacing (Medtronic) |
| LV Pacing | Experimental | Left ventricular pacing through coronary sinus tributaries Receives: Device: Left ventricular pacing through coronary sinus tributaries (Attain StarFix) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical success
Surgical success: absence of complications
Measured: Participants will be evaluated during the perioperative period and during the hospital stay, an expected average of 2 days
Secondary outcomes (1)
Echocardiographic and Clinical composite
Echocardiographic: ventricular dysfunction Clinical composite: all mortality, cardiovascular mortality, hospitalization, heart failure
Measured: Participants will be evaluated at 6 and 24 months after PM implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2015 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradyarrhythmiasStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Principal investigator, Roberto Costa, University of Sao Paulo
- Investigators
- Roberto Costa, MD PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717469
- Sponsor's protocol ID
- CAAE 00610412.2.0000.0068
- Acronym
- SAFE-LVPACE
- Status last verified
- Nov 2012
- First submitted
- 30 Sep 2012
- Last updated
- 6 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Study to Assess the Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias
- ClinicalTrials.gov ID
- NCT01717469
- Acronym / sponsor ID
- SAFE-LVPACE / CAAE 00610412.2.0000.0068
- Conditions
- Bradyarrhythmias, Arrhythmias, Atrioventricular Block, Ventricular Dysfunction, Cardiovascular Disease
- Keywords
- Pacemaker, Pacemaker implantation, Coronary sinus, Ventricular dysfunction, Right ventricular pacing, Left ventricular pacing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- Jun 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 30 Oct 2012 (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.
Previous experimental and clinical studies have consistently suggested that right ventricular (RV) apical pacing has important adverse effects. Ventricular pacing, however, is required, and cannot be reduced in many patients with atrioventricular block. The SAFE-LVPACE study is a randomized controlled trial that compare the effects of conventional right ventricular (RV) pacing vs. left ventricular (LV) in patients with AV block.
Detailed description
Over the past several years, there has been growing concern over the significant deleterious effects of RV pacing, including electromechanical dyssynchrony, proarrhythmia and development of heart failure (HF). However, it remains unclear whether pacing-related ventricular dyssynchrony can translate into significant LV structural changes and produce important clinical impairment in an average pacemaker population with compromised AV conduction. Alternatively, left ventricular pacing has been shown to minimize ventricular dyssynchrony and to improve symptoms and prognosis in patients with mild to moderated systolic HF and prolonged QRS duration.
This randomized controlled study is been conducted to compare the effects of conventional right ventricular (RV) pacing vs. left ventricular (LV) in patients with AV block. The hypothesis is that isolated LV pacing through the coronary sinus can be used safely and provide greater hemodynamic benefits to patients with AV block and normal ventricular function who require only the correction of heart rate.
Specifically, the investigator aims are to evaluate the safety, efficacy and the effects of left ventricular pacing using active-fixation coronary sinus lead-the Attain StarFix® Model 4195 OTW Lead, compared to right ventricular pacing in patients with implantation criteria for conventional pacemaker stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RV Pacing | Active comparator | Device: Right ventricular pacing (Medtronic)Right ventricular pacing |
| LV Pacing | Experimental | Device: Left ventricular pacing through coronary sinus tributaries (Attain StarFix)Left ventricular pacing through coronary sinus tributaries |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Older than 18 years
- Pacemaker initial implant by transvenous approach
- Presence of AV block
- Presence of atrial fibrillation / atrial flutter with slow ventricular response
- Left ventricular systolic function > 0.40
Key exclusion criteria (8 listed)
- Absence of venous access
- Impediment of venous access due to presence of intracardiac defects
- Impediment of venous access due to presence of tricuspid valve prosthesis
- Need for radiotherapy in the chest
- Presence of chest deformity
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 |
|---|---|---|
| Left ventricular pacing through coronary sinus tributaries (Attain StarFix)Also: Attain StarFix® Model 4195 OTW LeadLeft ventricular pacing in patients with bradycardia | Device | LV Pacing |
| Right ventricular pacing (Medtronic)Also: Right ventricular lead Medtronic 5076-58Conventional right ventricular pacing in patients with bradycardia. | Device | RV Pacing |
Primary outcome
Surgical success
Time frame: Participants will be evaluated during the perioperative period and during the hospital stay, an expected average of 2 days
Surgical success: absence of complications
1 secondary outcome
Echocardiographic and Clinical composite
Time frame: Participants will be evaluated at 6 and 24 months after PM implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2012.
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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.
Roberto Costa, MD PhD principal investigator
University of Sao Paulo
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 Left ventricular pacing through coronary sinus tributaries (Attain StarFix) and Right ventricular pacing (Medtronic) in people with Bradyarrhythmias and Arrhythmias, run by University of Sao Paulo at 1 site in Brazil.
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 6 inclusion and 8 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 6 Nov 2012. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roberto Costa, MD PhD (55-11-2661 ext. 5284, rcosta@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical success (time frame: Participants will be evaluated during the perioperative period and during the hospital stay, an expected average of 2 days). 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 6 Nov 2012.