Trial · NCT07885761
REVIVE-FR Registry
NCT07885761, Not yet recruiting, Institut für Pharmakologie und Präventive Medizin
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. REVIVE-FR Registry. Trials, record NCT07885761. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07885761
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- REVIVE-FR Registry
- NCT number
- NCT07885761
- Status
- Not yet recruiting
- Enrollment
- 200 participants, estimated
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Conditions
- Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction, Structural Valve Deterioration, Prosthetic Heart Valve Thrombosis, Prosthetic Valve Endocarditis
- Interventions
- TAVI-in-SAVR (Valve-in-Valve), THV-in-THV (Redo-TAVI), Surgical Explantation of a Failed Transcatheter Heart Valve, Medical management
- First posted
- 2026-10-21
- Last updated
- 2026-10-21
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | REVIVE-FR Success at 30 Days | 30 days after procedure | Proportion of patients in the TAVI-in-SAVR, THV-in-THV, and Explant-TAVR cohorts achieving REVIVE-FR success, a VARC-3-adapted composite endpoint. Success requires correct positioning of a single prosthetic heart valve in the proper anatomic location; intended valve performance (mean gradient \<20 mmHg, peak velocity \<3.0 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation); and freedom from mortality, coronary obstruction, unplanned coronary revascularization, and surgery or intervention related to the device. The endpoint is assessed separately for each of the three interventional cohorts and does not apply to the Medical-Management cohort. |
| Primary | Early Safety at 30 Days | 30 days after procedure | Determine VARC-3 defined early safety at 30 days: * Freedom from all-cause mortality * Freedom from all Stroke * Freedom from all VARC type 2-4 bleeding * Freedom from all major vascular, access-related, or cardiac structural complication * Freedom from all acute kidney injury stage III/IV * Freedom from all moderate/severe aortic regurgitation * Freedom from all new permanent pacemaker implantations due to procedure-related conduction abnormalities * Freedom from all surgery/intervention related to the device These events will be adjudicated. Number and percentage of subjects with early safety at 30 days as per VARC-3 definition, along with individual component of the success, will be presented. |
| Secondary | Clinical Outcomes at 1 Year | 1 year after procedure | Composite of freedom from all-cause mortality, stroke, and valve- or procedure-related rehospitalization in the TAVI-in-SAVR, THV-in-THV, and Explant-TAVR cohorts. |
| Secondary | Valve Durability at 1 Year | 1 year after procedure | Incidence of subclinical and clinical transcatheter heart valve thrombosis and Stage II/III structural valve degeneration according to VARC-3, assessed by echocardiography and 1-year CT where available. |
| Secondary | All-Cause and Cardiovascular Mortality in the Medical-Management Cohort | 1 year, and optional 2 years after procedure | All-cause and cardiovascular mortality will be assessed descriptively in patients managed medically for a failing transcatheter heart valve. Results will be reported as the number and percentage of patients, where appropriate. This outcome is intended for descriptive characterization and is not powered for direct comparison with the interventional cohorts. |
| Secondary | Heart Failure Hospitalization in the Medical-Management Cohort | 1 year; and optional 2-year after procedure | Occurrence of hospitalization for heart failure during follow-up will be assessed descriptively in the Medical-Management cohort. Results will be reported descriptively and are not intended for direct statistical comparison with the interventional cohorts |
| Secondary | Unplanned Aortic Valve Reintervention in the Medical-Management Cohort | 1 year; and optional 2-year after procedure | Occurrence of unplanned aortic valve reintervention, including crossover to TAVI-in-SAVR, THV-in-THV, or surgical explantation, will be assessed descriptively in patients initially managed medically. |
| Secondary | Echocardiographic Progression of Transcatheter Heart Valve Failure | 1 year; and optional 2-year after procedure | Progression of transcatheter heart valve failure will be assessed descriptively using echocardiographic findings, including changes in VARC-3 structural valve degeneration stage and, in patients with endocarditis, resolution or persistence of endocarditis. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07885761
GET https://conductscience.org/api/trials/v1/NCT07885761/registered