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CardioGenesis Transmyocardial Revascularization 1-Year Follow-Up Study

3. März 2021 aktualisiert von: CryoLife, Inc.

A Multi-Center Single Arm One Year Prospective Follow-Up of Patients Treated With the CryoLife CardioGenesis Holmium:YAG Laser System for Transmyocardial Revascularization (The TMR 365 Study)

The purpose of this study it to collect real world 30-day and 1-year follow-up data for patients undergoing TMR with the CardioGenesis Holmium:YAG Laser System either as a sole therapy procedure or in conjunction with coronary artery bypass graft (CABG) surgery.

The primary objective of this study is to provide ongoing clinical data regarding the characteristics of the patient population undergoing TMR in community practices. Secondary objectives include rates of postoperative mortality and MACE at 30-days and 1-year, and benefit of sustained improvement in angina at 30-days and 1-year.

The study includes two patient populations:

Registry Group: Patients from selected centers who previously participated in the ANGINA RELIEF Registry and are eligible for a one-year, prospective follow-up;
Prospective Group: Up to 100 new, prospectively enrolled TMR patients from selected centers.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Klasse-IV-Angina

Detaillierte Beschreibung

The study objectives are as follows:

Track "real world" performance outcomes and physician experience using the CardioGenesis Laser System;
Further define the disease characteristics of the population being treated;
Examine transmyocardial revascularization (TMR) usage characteristics, including surgical procedure information, and 30-day and 1-year outcomes;
Further assess the risk factors for adverse events at 30-days and 1-year;
Further define MACE rates and angina scores at 30-days and 1-year. To limit the potential for bias, all patients eligible for TMR treatment who meet the Inclusion and Exclusion Criteria will be offered the opportunity to enroll in the study at participating centers.

Primary Endpoint:

- 1-year Canadian Cardiovascular Society (CCS) angina class

Secondary Endpoints:

All-cause mortality at 30-day and 1-year.
Rates of major adverse cardiovascular events (MACE) at 30-days and 1-year, defined as the incidence of cardiac-related death, myocardial infarction (Q-wave and non Q-wave), congestive heart failure, cerebrovascular accident, and serious arrhythmia.

The definitions for MACE events are as follows:

Cardiac-related death: any death that is not clearly attributable to a non-cardiac cause, and includes death due to any of the following: acute myocardial infarction, heart failure, cardiogenic shock, pulmonary edema, cardiac tamponade, arrhythmia, or post-procedural complications (i.e., bleeding).
Q-wave myocardial infarction: the appearance of new Q waves of 40 or more milliseconds in 2 or more contiguous leads and elevation of CK-MB.
Non Q-wave myocardial infarction: the elevation of total CK more than twice normal with elevated CK-MB.
Congestive heart failure: Symptoms of pulmonary vascular congestion or a low output state that is due to left ventricular failure and is new in onset or results in re-hospitalization.
Cerebrovascular accident: Any sudden development of neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, or thrombosis that persists for > 24 hours.
Serious arrhythmia: Supra-ventricular or ventricular arrhythmias that require sustained intravenous pharmacologic treatment, temporary or permanent pacing, or immediate electrical cardioversion or defibrillation. Arrhythmias resulting in syncope, myocardial ischemia, or death are also classified as serious.
Any other serious operative complications related to the procedure: example: major bleeding requiring transfusion.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

114

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Vereinigte Staaten
- Florida
  - Jacksonville, Florida, Vereinigte Staaten, 32204
    - Cardiothoracic and Vascular Surgical Associates
- Tennessee
  - Nashville, Tennessee, Vereinigte Staaten, 37203
    - TriStar Cardiovascular Surgery

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

All patients who meet the eligibility criteria at the selected centers will be provided an opportunity to participate.

Beschreibung

Inclusion Criteria:

Registry Group: Previously enrolled in the ANGINA RELIEF Registry; Eligible for a 1-year prospective follow-up (date of TMR procedure performed within 12-18 month follow-up window).
Prospective Group: Received TMR with the CardioGenesis Laser System; Class IV angina (according to Canadian Cardiovascular Society Angina Scale) prior to TMR; Patients with regions of myocardium in the distal two-thirds of the left ventricle with reversible ischemia and who are not eligible for direct coronary revascularization (e.g., CABG or PTCA).

Exclusion Criteria:

Registry Group: Date of ANGINA RELIEF Registry TMR procedure performed outside 1-year (12-18 month) follow-up window.
Prospective Group: Age less than 18 years; Severely unstable angina (un-weanable from intravenous anti-anginals for 48-hours).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Anzahl der Gruppen / Kohorten

Kohorten und Interventionen

Gruppe / Kohorte
Registry Group Patients previously enrolled in the ANGINA RELIEF Registry who are eligible for a 1-year, prospective follow-up (date of ANGINA RELIEF Registry TMR procedure performed within 12-18 month follow-up window).
Prospective Group A group of up to 100 new, prospectively enrolled patients from active centers that receive TMR with the CardioGenesis Laser System and complete a 30-day and 1-year follow-up.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Change in Canadian Cardiovascular Society (CCS) Angina Class from Baseline (Class IV) at 1 Year. Zeitfenster: 1 year	Class I: Ordinary physical activity does not cause angina, such as walking and climbing stairs. Angina with strenuous or rapid or prolonged exertion at work or recreation; Class II: Slight limitation of ordinary activity. Walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, or in cold, or in wind, or under emotional stress, or only during the few hours after awakening. Walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal conditions; Class III: Marked limitation of ordinary physical activity. Walking one or two blocks on the level and climbing one flight of stairs in normal conditions and at normal pace; Class IV: Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest.	1 year

Sekundäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Rate of all cause mortality Zeitfenster: 30 days, 1 year	All-cause mortality	30 days, 1 year
Rates of Major Adverse Cardiovascular Events (MACE) Zeitfenster: 30 days, 1 year	Defined as the incidence of cardiac-related death, myocardial infarction (Q-wave and non Q-wave), congestive heart failure, cerebrovascular accident, and serious arrhythmia.	30 days, 1 year

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

CryoLife, Inc.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. März 2016

Primärer Abschluss (Tatsächlich)

1. Oktober 2020

Studienabschluss (Tatsächlich)

1. Oktober 2020

Studienanmeldedaten

Zuerst eingereicht

22. Februar 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. Februar 2016

Zuerst gepostet (Schätzen)