- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01717469
Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias (SAFE-LVPACE)
Randomized Clinical Study to Assess the Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Sao Paulo, Brazil, 05403-900
- Recruiting
- Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
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Sub-Investigator:
- Silvana AD Nishioka, MD, PhD
-
Contact:
- Robeto Costa, MD PhD
- Phone Number: 5284 55-11-2661
- Email: rcosta@gmail.com
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Principal Investigator:
- Roberto Costa, MD, PhD
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Sub-Investigator:
- Katia R Silva, RN, PhD
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Sub-Investigator:
- Caio MM Albertini, MD
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Sub-Investigator:
- Martino Martinelli Filho, MD, PhD
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Sub-Investigator:
- Wagner T Tamaki, MD, PhD
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Sub-Investigator:
- Irapuan M Penteado, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: RV Pacing
Right ventricular pacing
|
Conventional right ventricular pacing in patients with bradycardia.
Other Names:
|
EXPERIMENTAL: LV Pacing
Left ventricular pacing through coronary sinus tributaries
|
Left ventricular pacing in patients with bradycardia
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Participants will be evaluated during the perioperative period and during the hospital stay, an expected average of 2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Echocardiographic and Clinical composite
Time Frame: Participants will be evaluated at 6 and 24 months after PM implantation
|
Echocardiographic: ventricular dysfunction Clinical composite: all mortality, cardiovascular mortality, hospitalization, heart failure
|
Participants will be evaluated at 6 and 24 months after PM implantation
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life
Time Frame: Participants will be evaluated at 6 and 24 months after PM implantation
|
Quality of life: improvement on quality of life scores measured by three questionnaires: 36-Item Short Form Health Survey (SF-36), a disease specific questionnaire for pacemaker patients (Aquarel) and Minnesota Living With Heart Failure (MLWHF).
|
Participants will be evaluated at 6 and 24 months after PM implantation
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE 00610412.2.0000.0068
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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