Project Title: Effect of Ventricular Pacing on the Aortic Valve Pressure Gradient During TAVI Procedure
Principal Investigator:
Invitation to Participate
You are invited to participate in the research study on the effect of ventricular pacing on the aortic valve pressure gradient during a TAVI procedure. You are considered to be a good candidate to participate in this study because of your condition of severe aortic stenosis and you are undergoing a TAVI procedure, which are the important considerations of this research study.
Purpose of the Letter
This letter of information is provided to give you all the details that can help you make an informed decision concerning your participation in this research study. You are encouraged to read the information contained herein to give you a better concept regarding the purpose and goals that the research aims to achieve with your help, including the procedures, risks and benefits and other important matters involved in the process.
Purpose of this Study
The objective and focus of the research study are to investigate and explore the effect of ventricular pacing on the aortic valve pressure gradient during TAVI procedure by TEE immediately before placement of the aortic valve.
Inclusion Criteria
The major criteria required in the conduct of the study involve patients with severe aortic stenosis who are undergoing a TAVI procedure. No particular age group is considered in the study to be eligible since the main criteria being considered in undertaking the research is the presence of aortic stenosis with no reference to other criteria other than undergoing a TAVI procedure.
Exclusion Criteria
Individuals with severe and advanced aortic stenosis who cannot undergo an aortic valve replacement due to their old age, the presence of a left ventricular dysfunction and other underlying medical conditions are not eligible to participate and are thus excluded from the study.
Study Procedures
If you agree to participate, you should expect that a catheter probe will be inserted into your mouth to reach the esophagus in order to collect the necessary data about the valvular activities in your heart prior to the TAVI procedure. The procedure may take a while until all the information obtained through the sound waves coming from the TEE is completely collected. The procedure will be undertaken on a single session and will be made during your TAVI procedure, but prior to the balloon dilation. There will be a total of 100 patients who will participate in the study who have a similar condition as you do.
Possible Risks and Harms
The procedure involves a minimal discomfort upon the insertion of the probe into your mouth. However, this is mitigated by the administration of a medicine that will help make your mouth and throat feel numb and to calm you down. Gagging is common, but it does not involve some serious risks or long term discomfort. You will normally feel some sore throat within a day or two after the procedure. In some cases, the esophagus may bleed upon the insertion of the probe.
Possible Benefits
The potential benefit in conducting the research study is the determination on how the aortic valve pressure gradient can be reduced through the process of ventricular pacing at the rate of 5 to 10 b/m more than the baseline heart rate. While the study may not directly benefit you, it can provide a significant contribution on how to improve the TAVI procedure among high risk patients who cannot be eligible for the same. This research can help patients with a heart condition enhance their chance for a better survival rate.
Compensation
All research participants will be compensated for their valuable participation and cooperate that will make the study meaningful and possible. Should you fail you complete the entire process required for the study, the amount of your compensation will be pro-rated according to the length and extent of your participation in the study.
Voluntary Participation
Participation in this study is voluntary. You can always refuse to participate or answer certain questions and you can withdraw your participation in the study at any stage of the process. This will not affect any future care that you will receive for your condition, nor will it affect your current health status at the time of your withdrawal.
Confidentiality
All research data, personal information and other pertinent records involving the research will be treated with high confidentiality. Access thereto shall only be available to the researchers who are directly involved in the research. It is also possible that in the future or at any stage of the study, the ethics committee may also access some of the research data and information to ensure that ethical standards in the conduct of the research are observed. Should you decide to withdraw your participation in the study, your personal information and other related data will not be stored, but will be discarded or removed from our database.
Contacts for Further Information
For special concerns and if you need more clarification about the research study, you may contact ________________.
Publication
Upon the completion of the study and the same is published, your personal data will be held confidential and will not be disclosed to the public. Should you like to obtain a copy of the outcome of the research, you may contact ______ at _________.
Consent
Consent Form
Project Title: Effect of Ventricular Pacing on the Aortic Valve Pressure Gradient During TAVI Procedure
Study Investigator’s Name:
I have read the Letter of Information and the same provided me with the information I need to help me make an informed decision. All questions I may have involving the study have been answered to my satisfaction. I hereby voluntarily join this undertaking as a participant in the above-named research study.
Child’s Name: (if applicable) ______________________________________________
Participant’s Name (please print): _______________________________________________
Participant’s Signature: _______________________________________________
Parent / Legal Guardian / Legally Authorized Representative (if applicable) Print: __________
Parent / Legal Guardian / Legally Authorized Representative (if applicable) Sign: ___________
Parent / Legal Guardian / Legally Authorized Representative (if applicable) Date: ___________
Person Obtaining Informed Consent (please print): _____________________________
