SIRONA 2 Trial Heart Failure NYHA Class III

Status Active, not recruiting

Clinical Trial Summary

This is a prospective, multi-center, open-label, single-arm CE-Mark trial to assess device safety and efficacy of the Cordella PA Sensor System in up to 75 New York Heart Association (NYHA) Class III Heart Failure patients who will receive the Cordella PA Sensor Implant.

Clinical Trial Description

The study objectives are: 1. To establish that the Cordella PA Sensor can be safely delivered, deployed, and remain stable within the target pulmonary artery (PA) segment through 30 days post-implant. 2. To compare Cordella PA Sensor System pressure measurements with fluid-filled catheter PA pressure measurements obtained by standard right heart catheterization (RHC) at 90 days post implant. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04012944
Study type	Interventional
Source	Endotronix, Inc.
Contact
Status	Active, not recruiting
Phase	N/A
Start date	June 26, 2019
Completion date	July 2027

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04452149` - Algorithm Using LINQ Sensors for Evaluation And Treatment of Heart Failure	N/A
Not yet recruiting	`NCT06097481` - Narrative Intervention for Chronic Illness- Heart Failure Trial (NICI-HF)	Phase 1/Phase 2
Withdrawn	`NCT03005184` - Mechanism(s) Underlying Cardiovascular Effects of ARB/NEP Inhibition - Aim 2	Phase 2
Not yet recruiting	`NCT01669395` - Severe Heart Failure and Homebased Rehabilitation - An Intersectoral Randomized Controlled Trial	N/A
Completed	`NCT05835063` - A Study to Improve Physician-Youth Communication and Medical Decision Making	N/A
Completed	`NCT03895073` - HEart fAiluRe evaluaTion Questionnaire
Completed	`NCT03095196` - Multipolar CRT-d and Diabetes	N/A
Recruiting	`NCT03180320` - Baduanjin-eight-silken-movement With Self-efficacy Building for Patients With Chronic Heart Failure (BESMILE-HF Study)	N/A
Completed	`NCT06233695` - Gender-based Differences in the Outcome of Treatment With Aldosterone Antagonists in Patients With Heart Failure
Withdrawn	`NCT03947853` - Clinical Study to Evaluate the Predictive Value of the Heart Failure Questionnaire (HF-Q) for the Occurrence of Μajor Αdverse Cardiovascular Events (MACE) in Patients With Symptomatic Heart Failure
Recruiting	`NCT05934487` - PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III	N/A
Recruiting	`NCT04829617` - Promoting Well-being and Health in Heart Failure	N/A
Recruiting	`NCT03538990` - Effect of DASH Eating Pattern on Heart Failure Outcomes	N/A
Recruiting	`NCT05487365` - Implementation and Cost-evaluation of a Smartphone-based Telemonitoring and Digital Support in Patients With HF	N/A
Completed	`NCT03592836` - Diuretic Response in Advanced Heart Failure: Bolus Intermittent vs Continuous INfusion	Phase 3
Completed	`NCT01560871` - Effects of a Walking Program and Inspiratory Muscle Training in Individuals With Chronic Heart Failure	N/A
Completed	`NCT03387813` - Hemodynamic-GUIDEd Management of Heart Failure	N/A
Not yet recruiting	`NCT06270875` - Addressing Pain Through Navigator-Led Palliative Care Optimized for Heart Failure (ADAPT-HF)	N/A
Enrolling by invitation	`NCT05885607` - Early Metabolic Adaptations to SGLT2 Inhibition in Heart Failure
Recruiting	`NCT05879887` - An Optimization Pilot to Optimize An Early Palliative Care Intervention for Advanced Heart Failure	N/A