Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04525339
Other study ID # TAVI & OPCAB
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date August 2021

Study information

Verified date August 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Study Objectives/Specific Aims Overall Goal: To study the outcomes of patients undergoing TAVI, their subsequent results and complications.

- Objective 1: Identify risk factors that are predictive of the need for TAVI and CABG

- Objective3:Assess early 3 months outcomes and postoperative results

Outcome Measure:

1. All-cause mortality within 3 months.

Secondary Outcome Measures:

1. Stroke

2. Myocardial infarction

3. Bleeding

4. Hospital stay

5. Acute kidney injury

6. Number of patients with conduction disturbance and pacemaker implantation

7. Gradient on implanted valve

8. Degree of transvalvular leakage

9. 6 weeks follow-up

10. 3 months Echo


Description:

Severe symptomatic aortic stenosis in elderly patients represents a surgical challenge for cardiac surgeons due to heavy calcifications and associated comorbidities. Such conditions usually are associated with dramatic intra and postoperative complications leading to many cases being declined for open surgical replacement. Many treatment modalities were described including trans-catheter valvutomy but with only temporary improvements and high rates of recurrence. Transcatheter Aortic Valve Implantation (TAVI) has offered an alternative solution to such cases in which open surgery is deemed too risky or prohibited.

Coronary artery disease (CAD) is a common comorbidity in patients undergoing TAVI. It has been reported with 40-75% of the patients with increased adverse outcomes.Despite performing TAVI alone in these patient has shown significant improvement, yet CAD has showed increased risk in terms of hemodynamic instability and risk of myocardial infarction during rapid pacing which is an important step during the TAVI procedure.

According to the AHA/ACC guidelines, in patients undergoing Aortic valve replacement/ repair (AVR) who also have significant CAD, the combination of Coronary artery bypass grafting (CABG) and AVR reduces the rates of perioperative Myocardial Infarction, perioperative mortality, late mortality, and morbidity when compared with patients not undergoing simultaneous CABG, even though the combined operation carries a small but real increased risk of mortality (Class II A).

Percutaneous coronary intervention (PCI) has been the commonly used treatment modality for (CAD) which is usually carried out pre TAVI or less commonly simultaneously with TAVI (mainly due to access limitation after valve implantation). In patients with intermediate or high SYNTAX scores, CABG remains the standard therapy. Off-pump coronary artery bypass (OPCAB) procedure has demonstrated excellent results in these patients, due to the avoidance of cardiopulmonary bypass and manipulation of the aorta.

Only a few studies in the literature have reported the combined approach of CABG and TAVI in treatment of coronary artery disease and severe symptomatic aortic stenosis. Here the invesigators decided to study the early three months outcomes of patients undergoing TAVI and surgical revascularization.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 15
Est. completion date August 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with severe symptomatic aortic stenosis and CAD undergoing TAVI & OPCABG

Exclusion Criteria:

- Patients with concomitant valvular heart disease.

Study Design


Intervention

Procedure:
TAVI and Off pump CABG
Concomitant Transcatheter aortic valve implanatation and off pump coronary artery bypass grafting

Locations

Country Name City State
Egypt Assiut University Assiut

Sponsors (2)

Lead Sponsor Collaborator
Assiut University Manchester University NHS Foundation Trust

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause mortality 3 months
Secondary Occurence of Stroke I month
Secondary Occurence of Myocardial infarction I month
Secondary Need for reexploration I month
Secondary Occurence of Acute kidney injury I month
Secondary Number of patients with conduction disturbance and pacemaker implantation I month
Secondary Gradient on implanted valve 3 months Echo
Secondary Degree of transvalvular leakage 3 months Echo
Secondary Days of Hospital Stay from day of operation till medically fit for discharge (1 month)
See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions N/A