Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06177392 |
| Other study ID # |
VARC-TAVI 6571-2023.735 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 8, 2024 |
| Est. completion date |
December 1, 2025 |
Study information
| Verified date |
January 2024 |
| Source |
Hospital Universitario La Paz |
| Contact |
Daniel Tébar Márquez DTM Daniel Tébar Márquez, MD |
| Phone |
+034 695-86-03-09 |
| Email |
daniel.tebar.m[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
SUMMARY:
The investigators are planning a clinical study to compare two methods of performing a
procedure called TAVI, used in patients with severe aortic stenosis. In this procedure, the
aortic valve is replaced in a less invasive way. Traditionally, access through the groin
(femoral) is used, but now radial access (through the wrist) is being considered as an
alternative.
Reasons for the Study:
- Currently, there is not enough solid evidence to support the choice between these two
accesses.
- The investigators want to understand if radial access could be safer and have fewer
complications compared to femoral access.
What the Investigators Will Measure:
- Major complications, such as bleeding or vascular injuries.
- Other important outcomes, such as functional recovery and quality of life.
How the Investigators Will Do It:
- The investigators will randomize patients to receive radial or femoral access.
- The investigators will record which type of access is used and assess complications and
outcomes.
- The investigators will compare the results to understand if there are significant
differences between the two groups.
Ultimate Goal:
- The investigators aim to improve the safety and efficacy of this procedure for patients.
- The results of this study will help doctors make informed decisions on how to perform
TAVI.
Conclusion:
- This study is crucial for enhancing care for patients with aortic stenosis and ensuring the
procedure is performed in the safest and most effective manner. The results will benefit
patients and guide doctors in choosing the best approach for each individual.
Description:
INTRODUCTION:
The TAVI procedure has been established as a safe and effective alternative for aortic valve
replacement in patients with severe aortic stenosis. Vascular access plays a crucial role
during the TAVI procedure, allowing the introduction of necessary devices for valve
implantation, as well as protection and resolution of potential complications. Traditionally,
femoral access has been the preferred approach for both main access (through which the valve
navigates) and secondary access (serving as a guide during implantation and protection of the
main access) due to its familiarity and technical ease. However, in recent years, radial
access has gained popularity due to its theoretical potential to reduce vascular
complications and improve participant recovery and quality of life. In this study, the
investigators aim to demonstrate if there are differences between radial and femoral
secondary access in transfemoral TAVI implantation.
JUSTIFICATION:
Conducting a clinical trial comparing radial and femoral secondary access in transfemoral
TAVI implantation is crucial for several fundamental reasons. The main aspects supporting the
need for such a clinical trial are outlined below.
1. Limited and Heterogeneous Evidence:
- Observational studies and retrospective data supporting radial access as
contralateral access during TAVI implantation exist, but they are non-randomized
and subject to biases and methodological limitations. Prospective and controlled
clinical trials are required to generate solid and reliable evidence.
2. Differences in Complication Rates:
- Multiple clinical trials have shown a reduction in both vascular and non-vascular
complications, major and minor, with radial access compared to femoral access in
coronary catheterizations, even demonstrating a reduction in mortality. Similarly,
observational studies suggest a similar trend for femoral and radial access as
secondary access in TAVI, but these studies have multiple biases. A clinical trial
would provide higher-level evidence regarding the existence of differences in
vascular complications associated with the procedure.
- Bleeding and Transfusions: Bleeding is a common complication after TAVI and is
associated with increased morbidity and mortality. Several studies have
demonstrated a reduction in bleeding and the need for transfusions in TAVI
participants with radial access compared to femoral access.
- Other Complications: Meta-analyses of observational studies have also observed a
reduction in peri-procedural renal failure and stroke in participants with radial
access. However, due to study limitations, other variables may influence these
observations, requiring evaluation in a clinical trial.
- Given that participants undergoing aortic valve replacement are often elderly,
multimorbid, and somewhat frail, achieving total and early functional recovery is
crucial. Studies in coronary catheterizations have shown better functional recovery
and higher quality of life parameters with radial access. No studies have evaluated
this in TAVI procedures, and a clinical trial would allow studying this outcome.
- In conclusion, radial access has emerged as a potentially favorable alternative to
femoral access as secondary access in TAVI. Current evidence suggests that radial
access may be associated with a lower rate of vascular complications, bleeding, and
the need for transfusions, as well as other complications not directly related to
access. However, prospective and controlled clinical trials are needed to confirm
these findings and establish clear guidelines for choosing secondary access in
TAVI. These studies will provide a more accurate and informed understanding of the
differences between radial and femoral access in terms of safety and efficacy in
the context of TAVI implantation.
EVALUATION OF RELEVANT CLINICAL OUTCOMES:
In addition to vascular complications and other complications, a comparative clinical trial
would allow for less biased evaluation of other relevant aspects of the chosen access type,
such as radial access feasibility, crossover percentage, procedure success, etc. These
results would provide essential information to guide clinical decision-making.
IDENTIFICATION OF BENEFITED PATIENT SUBGROUPS:
A comparative clinical trial could help identify participant subgroups that would benefit
more from one type of access over another in terms of clinical outcomes and safety. There are
indications of specific predictors of femoral vascular complications, such as peripheral
arterial disease, angiographically visualized calcification of the femoral access, chronic
kidney disease, etc. These could be verified in such a study, allowing for more personalized
care for each participant, optimizing outcomes.
CLINICAL PRACTICE GUIDELINES:
Since evidence in this specific field is scarce and of low quality, the results of a clinical
trial would have a significant impact on the development of guidelines and recommendations
for clinical practice. Current guidelines provide limited guidance on the choice of secondary
access in TAVI. Evidence generated through a clinical trial would help establish more robust
and scientifically based recommendations.
In summary, conducting a clinical trial comparing radial and femoral access as secondary
access in transfemoral TAVI implantation is essential to fill gaps in existing evidence and
provide solid data to support clinical decision-making. This type of trial would allow a
systematic assessment of complications, relevant clinical outcomes, and the identification of
potentially more benefited participants.
METHODS:
Participants will be randomly assigned to one of two groups: radial access or femoral access.
Comprehensive preoperative evaluations will be conducted, including medical history, physical
examination, imaging tests, and cardiological assessments. During the TAVI procedure, data on
the access used, success, procedure duration, intra-procedural complications, and valve
implantation outcomes will be recorded. Results at discharge and 30 days will also be
documented.
1. Study Design:
- A prospective, randomized, controlled clinical trial will be conducted to evaluate
radial versus femoral secondary access in percutaneous aortic valve implantation
(TAVI). Eligible participants will be randomly assigned to receive radial or
femoral access as secondary access in transfemoral TAVI. Data on the access used,
success, procedure duration, intra-procedural complications, and valve implantation
outcomes will be recorded during the TAVI procedure.
2. Primary Objectives:
- Compare the overall incidence of major access complications (both vascular and
non-vascular) between radial and femoral access at discharge. Major access
complications are defined as:
- Major Vascular Complication:
- Aortic dissection or rupture.
- Arterial or venous vascular injury resulting in death, bleeding ≥2 VARC*, limb or
visceral ischemia, or irreversible neurological damage. This includes perforation,
dissection, stenosis, ischemia, arterial or venous thrombosis (including pulmonary
embolism), arteriovenous fistula, pseudoaneurysm, hematoma, retroperitoneal
hematoma, infection, or compartment syndrome.
- Distal (non-cerebral) embolization from a vascular source resulting in death,
amputation, limb or visceral ischemia, or irreversible damage to end organs.
- Unplanned endovascular or surgical intervention resulting in death, bleeding ≥2
VARC*, limb or visceral ischemia, or irreversible neurological damage.
- Device closure failure resulting in death, bleeding ≥2 VARC*, limb or visceral
ischemia, or
irreversible neurological damage.
- Major Non-Vascular Complication:
- Non-vascular or non-cardiac structure perforation, injury, or infection resulting
in death, bleeding ≥2 VARC*, irreversible nerve injury, or requiring unplanned
intervention or surgical intervention.
- Device migration, embolization, or malposition resulting in death, bleeding ≥2
VARC*, limb or visceral ischemia, or irreversible neurological damage.
- Air or gas embolism resulting in death, bleeding ≥2 VARC*, limb or visceral
ischemia, or irreversible neurological damage.
- Valve-related infectious endocarditis resulting in death, bleeding ≥2 VARC*, limb
or visceral ischemia, or irreversible neurological damage.
- Cardiac injury resulting in death, bleeding ≥2 VARC*, limb or visceral ischemia, or
irreversible neurological damage.
- Valve embolization resulting in death, bleeding ≥2 VARC*, limb or visceral
ischemia, or irreversible neurological damage.
3. Secondary Objectives:
- Compare secondary endpoints between radial and femoral access at discharge and 30
days post-TAVI, including:
- Individual components of major access complications.
- Bleeding complications.
- Transfusions.
- Peri-procedural renal failure.
- Stroke.
- Functional recovery.
- Quality of life parameters.
4. Study Population:
- Eligible participants will include adult participants diagnosed with severe aortic
stenosis scheduled for elective transfemoral TAVI.
5. Sample Size Calculation:
- The sample size will be calculated based on the primary endpoint, considering a
two-sided significance level of 0.05 and a power of 80%. A presumed major access
complication rate of 10% in the femoral group and a hypothesized reduction to 5% in
the radial group will be used for the calculation.
6. Statistical Analysis:
- Descriptive statistics will be used to summarize baseline characteristics.
Categorical variables will be compared using chi-square or Fisher's exact test, and
continuous variables will be compared using t-tests or non-parametric tests, as
appropriate. The primary endpoint will be analyzed using logistic regression,
adjusting for relevant covariates. Secondary endpoints will be analyzed similarly.
Subgroup analyses will be conducted to explore potential differences in treatment
effects across subgroups defined by relevant baseline characteristics.
7. Ethical Considerations:
- The study will be conducted in accordance with the principles of the Declaration of
Helsinki and Good Clinical Practice guidelines. Ethical approval will be obtained
from the relevant institutional review board. Informed consent will be obtained
from all participants before enrollment.
8. Data Collection and Monitoring:
- Data will be collected by trained study personnel using standardized case report
forms. Data monitoring will be conducted regularly to ensure data quality and
participant safety.
9. Trial Oversight:
- An independent data and safety monitoring board will be established to oversee the
progress and safety of the trial. Periodic reviews will be conducted to assess the
accumulating data and make recommendations regarding continuation, modification, or
termination of the trial.
10. Dissemination of Results:
- The results of the trial will be disseminated through peer-reviewed publications
and presentations at relevant scientific conferences. The data will be shared with
the wider scientific community to contribute to the evidence base in the field of
TAVI.
EXPECTED OUTCOMES:
This clinical trial aims to provide high-quality evidence regarding the safety and efficacy
of radial versus femoral secondary access in transfemoral TAVI. The primary outcome measure,
major access complications, will be rigorously assessed, and secondary outcomes will provide
a comprehensive understanding of potential differences between the two access types. The
results will contribute to the development of evidence-based guidelines and recommendations
for clinical practice, ultimately improving participant outcomes and optimizing the delivery
of TAVI procedures.
CONCLUSION:
The proposed clinical trial is designed to address the existing gaps in evidence regarding
the choice of secondary access in transfemoral TAVI implantation. By conducting a randomized,
controlled trial, the investigators aim to provide robust data on the safety and efficacy of
radial versus femoral access, informing clinical decision-making and contributing to the
development of guidelines in the field of TAVI. This research has the potential to enhance
participant care, improve procedural outcomes, and guide future research in the dynamic field
of transcatheter aortic valve implantation.
