Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias (SAFE-LVPACE)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified November 2012 by University of Sao Paulo
Sponsor:
University of Sao Paulo
Collaborator:
Duke University
Information provided by (Responsible Party):
Roberto Costa, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01717469
First received: September 30, 2012
Last updated: November 5, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bradyarrhythmias Arrhythmias Atrioventricular Block Ventricular Dysfunction Cardiovascular Disease |
Device: Left ventricular pacing through coronary sinus tributaries (Attain StarFix) Device: Right ventricular pacing (Medtronic) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Clinical Study to Assess the Safety and the Effects of Isolated Left Ventricular Pacing in Patients With Bradyarrhythmias |
Resource links provided by NLM:
Further study details as provided by University of Sao Paulo:
Primary Outcome Measures:
- Surgical success [ Time Frame: Participants will be evaluated during the perioperative period and during the hospital stay, an expected average of 2 days ] [ Designated as safety issue: Yes ]Surgical success: absence of complications
Secondary Outcome Measures:
- Echocardiographic and Clinical composite [ Time Frame: Participants will be evaluated at 6 and 24 months after PM implantation ] [ Designated as safety issue: Yes ]Echocardiographic: ventricular dysfunction Clinical composite: all mortality, cardiovascular mortality, hospitalization, heart failure
Other Outcome Measures:
- Quality of Life [ Time Frame: Participants will be evaluated at 6 and 24 months after PM implantation ] [ Designated as safety issue: No ]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).
| Estimated Enrollment: | 12 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: RV Pacing
Right ventricular pacing
|
Device: Right ventricular pacing (Medtronic)
Conventional right ventricular pacing in patients with bradycardia.
Other Name: Right ventricular lead Medtronic 5076-58
|
|
Experimental: LV Pacing
Left ventricular pacing through coronary sinus tributaries
|
Device: Left ventricular pacing through coronary sinus tributaries (Attain StarFix)
Left ventricular pacing in patients with bradycardia
Other Name: Attain StarFix® Model 4195 OTW Lead
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717469
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717469
Contacts
| Contact: Roberto Costa, MD PhD | 55-11-2661 ext 5284 | rcosta@incor.usp.br | |
| Contact: Katia R Silva, RN PhD | 9195978619 | katia.research@gmail.com |
Locations
| Brazil | |
| Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | Recruiting |
| Sao Paulo, Brazil, 05403-900 | |
| Contact: Robeto Costa, MD PhD 55-11-2661 ext 5284 rcosta@gmail.com | |
| Contact: Katia R Silva, RN PhD 9195978619 katia.research@gmail.com | |
| Principal Investigator: Roberto Costa, MD, PhD | |
| Sub-Investigator: Elizabeth S Crevelari, MD | |
| Sub-Investigator: Katia R Silva, RN, PhD | |
| Sub-Investigator: Caio MM Albertini, MD | |
| Sub-Investigator: Marianna S Lacerda, RN | |
| Sub-Investigator: Martino Martinelli Filho, MD, PhD | |
| Sub-Investigator: Wagner T Tamaki, MD, PhD | |
| Sub-Investigator: Roberto M Oliveira Jr, MD | |
| Sub-Investigator: Wilson Mathias Jr, MD, PhD | |
| Sub-Investigator: Silvana AD Nishioka, MD, PhD | |
| Sub-Investigator: Irapuan M Penteado, MD | |
Sponsors and Collaborators
University of Sao Paulo
Duke University
Investigators
| Principal Investigator: | Roberto Costa, MD PhD | University of Sao Paulo |
More Information
| Responsible Party: | Roberto Costa, Associated Professor of Cardiovascular Surgery, MD PhD, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT01717469 History of Changes |
| Other Study ID Numbers: | CAAE 00610412.2.0000.0068 |
| Study First Received: | September 30, 2012 |
| Last Updated: | November 5, 2012 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by University of Sao Paulo:
|
Pacemaker Pacemaker implantation Coronary sinus |
Ventricular dysfunction Right ventricular pacing Left ventricular pacing |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Ventricular Dysfunction Atrioventricular Block Bradycardia |
Heart Diseases Heart Block Arrhythmias, Cardiac Pathologic Processes |
ClinicalTrials.gov processed this record on September 30, 2016