Structured Shared Decision Making for Patients Undergoing SAVR or TAVR

Not Applicable

Recruiting

• Conditions: Aortic Valve Stenosis; Symptomatic Aortic Stenosis
• Interventions: Other: Structured SDM; Other: Usual Care

• Registration Number: NCT05711186
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

Transcatheter aortic valve replacement (TAVR) is a well-established alternative to surgical aortic valve replacement (SAVR) for the treatment of patients with severe aortic stenosis regardless of surgical risk. While TAVR and SAVR share some of the benefits and risks, they importantly differ with regards to invasiveness, time to recovery, hemodynamics, as well as options for re-intervention and possibly valve durability. An early benefit of TAVR may be offset by late risks. Therefore, current guidelines of the European Society of Cardiology recommend an integration of patient values and preferences for the selection of the treatment modality.

The objective of the TOGETHER trial is to investigate the efficacy of a structured shared decision making approach (SDM) to improve patient-centered outcomes for the choice between SAVR and TAVR.

TOGETHER is an investigator-initiated, randomized, open-label, single-center clinical trial. A total of 140 patients referred for treatment of symptomatic severe aortic stenosis and deemed to undergo TAVR or SAVR according to heart team decision will be randomized in a 1:1 ratio to structured SDM or usual care.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-24
• Study First Submitted QC: 2023-01-24
• Study First Posted: 2023-02-02
• Study Start: 2023-04-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Primary Completion: 2024-12-31
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Age ≥ 70 years
2. Symptomatic severe aortic stenosis defined by an aortic valve area ≤1.0 cm2 or an aortic valve area indexed to body surface area <0.6cm2/m2
3. Both SAVR and transfemoral TAVR as reasonable treatment options based on heart team decision

Exclusion Criteria

1. Life expectancy <1 year irrespective of valvular heart disease
2. Inability to provide informed consent
3. Participation in another clinical trial with an active intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Structured SDM	Structured SDM	Structured shared decision making for the choice between SAVR and TAVR
Usual Care	Usual Care	Usual care for the choice between SAVR and TAVR

Primary Outcome Measures

Name	Time	Method
Patient decisional conflict	3 days post baseline visit	Assessed by decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Patient decisional regret	30 days post TAVR/SAVR	Assessed by the decision regret scale (ranges from 0 to 100, with higher scores indicating a worse outcome)

Secondary Outcome Measures

Name	Time	Method
The incidences of major clinical adverse events	30 days and 1 year post TAVR/SAVR	All-cause mortality, stroke, transient ischemic attack, bleeding event, kidney injury, systemic embolism, myocardial infarction, new onset atrial fibrillation, permanent pacemaker implantation and intervention related to the device
Patient knowledge about the treatment options and outcomes	3 days post baseline visit	Assessed by 6 multiple-choice items (ranges from 0 to 6, with higher scores indicating a better outcome)
Patient decisional satisfaction	3 days post baseline visit; 30 days and 1 year post TAVR/SAVR	Assessed by Likert Scale (ranges from 1 to 5, with higher scores indicating a better outcome)
Quality of choice	3 days post baseline visit	Assessed by effective decision subscore of the decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Patient health-related quality of life	30 days post TAVR/SAVR	Assessed by KCCQ 12 (Kansas City Cardiomyopathy Questionnaire) (ranges from 0 to 100, with higher scores indicating a better outcome)
The proportion of patients choosing TAVR/SAVR	Baseline	Number of participants choosing valve replacement by TAVR or SAVR
Patient-centered communication	3 days post baseline visit	Assessed by CollaboRATE scale (ranges from 0 to 100, with higher scores indicating a better outcome)
Patient procedural satisfaction	3 days post baseline visit	Assessed by Likert Scale (ranges from 1 to 5, with higher scores indicating a better outcome)
Patient feeling of not being informed	3 days post baseline visit	Assessed by informed subscore of the decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Incorporation of patient values	3 days post baseline visit	Assessed by values clarity subscore of the decisional conflict scale (ranges from 0 to 100, with higher scores indicating a worse outcome)
Patient decisional regret	1 year post TAVR/SAVR	Assessed by the decision regret scale (ranges from 0 to 100, with higher scores indicating a worse outcome)

Trial Locations

Locations (1)

Bern University Hospital, Dep. of Cardiology; 🇨🇭 Bern, Switzerland